Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain, Anxiety in Colorectal Cancer Surgery

January 28, 2021 updated by: YASEMİN ÖZHANLI

The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety in Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study

This research was carried out as an pre-test/post-test control group experimental design study in order to determine the effect of progressive relaxation exercises on the level of vital sign, pain and anxiety underwent who laparoscopic surgery for colorectal cancer in patients. This research data was collected between March 2018 and May 2019. The research was carried out with 63 patients (experiment group= 31, control group= 32) who underwent elective laparoscopic colorectal surgery in a general surgery clinic of a university hospital in Istanbul and in accordance with the research criteria. Patients in the experiment group were taught breathing exercises in the preoperative period and on the 1st, 2nd and 3rd day after surgery then, progressive relaxation exercise that lasted 15 minutes was applied to the group. Pain (Short McGill Pain Scale) and anxiety (STAI-S Scale) levels of both groups were evaluated in the preoperative and postoperative period. The patient's vital signs, oxygen saturation and serum cortisol level parameters were measured in the same time interval before and after the relaxation exercise. Significance was evaluated at p <0.05 and p<0,001 levels in the analysis of the data. Prior to the study, the consent of the institution and ethics committee, written and verbal patient consent were obtained.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The universe of the study consisted of patients with colorectal cancer who were admitted to Istanbul University, Istanbul Faculty of Medicine, General Surgery Clinics for treatment between March 2018 and May 2019 and who would undergo laparoscopic surgery.The research was planned as a randomized controlled experimental study. Block randomization method was to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program(https://www.randomizer.org/) was used. Randomization done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list.Research data will be collected in a hospital's general surgery ward between March 2018 and May 2019. The independent variable of the study is Progressive Relaxation Exercise.The dependent variables of the study are physiological parameters, pain, anxiety and serum cortisol. In the research, "Individual Characteristics Form" and "Patient Follow-up Form" prepared by the researcher in line with the literature will be used as data collection tools.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34000
        • Istanbul University-Istanbul Medical Faculty Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being 18 years or over,
  • Consenting to participate in the study with verbal and written declaration after being informed,
  • Being scheduled for elective laparoscopic colorectal cancer surgery,
  • Not participating in another randomized controlled study simultaneously.

Exclusion Criteria:

  • Having a health problem that will alter cortisol release,
  • Preoperative and postoperative unconsciousness,
  • Having a psychiatric problem,
  • Having a disease that requires corticosteroid therapy,
  • Developing any complications during the operation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Progressive Relaxation Exercise
In individuals with normal daily circadian rhythms, cortisol levels peak at 8:00 AM, followed by a constantly declining daily cycle throughout the day. Therefore, it is important to collect blood samples taken for the measurement of serum cortisol levels approximately at the same time. Venous blood samples (3 ml) were obtained from the upper arm at 06:45 AM to evaluate the baseline and 45 minutes after Progressive Relaxation Exercise at 08:00. Vital signs and oxygen saturation were assessed at 6:30 AM before Progressive Relaxation Exercise and at 07:20 AM 5 minutes after Progressive Relaxation Exercise. Measurements were performed in the morning on the day of surgery and on postoperative days 1, 2, and 3.
Behavioral: Progressive Relaxation Exercise
Progressive Relaxation Exercise involves stretching sixteen muscle groups while breathing in sequentially, relaxing while exhaling. Exercise can be from head to toe or from foot to head. In order for the technique to be effective, it is important to have affective (music, etc.) and visual aids. During the exercise, the patient should complete the processes of perceiving the tension in his body, maintaining control and getting into a state of relaxation. After the patient is informed about the exercise, the person starts with breathing exercises. A deep but relaxing breath is taken from the nose, and lips are given by contracting simultaneously with relaxation. During this application, the patient keeps contracting the muscle group that he exercises for 10 seconds; the nurse provides the patient to notice the temperature / warming felt in the muscle group.
NO_INTERVENTION: Standard Care
In the control group, no application made during and after the surgical intervention, and routine treatment and care applied.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Preoperative pain severity
Time Frame: Preoperative pain assessment of the groups was made 2 hours before surgery.

Pain severity assessment with Short Form McGill Pain Questionnaire In the first part, pain intensity is evaluated as 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain In the second part, the pain felt is evalauted using the Visuel Analog Scale (VAS).0-10; 0- No Pain, 10- Worst pain In the third part, the total pain intensity is measured with a 6-point Likert-type assessment. (0=no pain, 1=mild, 2=annoying , 3=troublesome, 4=miserable, 5=unbearable pain) Pain assessment for the experimental group Preoperative pain assessment of the experimental group was made before applying the progressive relaxation exercise. This evaluation was made 2 hours before surgery (6.30 am).

Pain assessment for the control group Preoperative pain assessment of the control group was made 2 hours before the operation in order to ensure the equivalence between the groups (6.30 am).
Preoperative pain assessment of the groups was made 2 hours before surgery.
Preoperative anxiety severity
Time Frame: Preoperative anxiety assessment of the groups was made 2 hours before surgery.

Anxiety severity with Spielberger's State and Trait Anxiety Inventory State Anxiety Subscale are specified by choosing one of the options "1) not at all, 2) somewhat, 3) moderately so, and 4) very much so" according to the severity of such experiences.

Anxiety assessment for the experimental group Preoperative anxiety assessment of the experimental group was made before applying the progressive relaxation exercise. This evaluation was made 2 hours before surgery (6.30 am).

Anxiety assessment for the control group Preoperative anxiety assessment of the control group was made 2 hours before the operation in order to ensure the equivalence between the groups (6.30 am).
Preoperative anxiety assessment of the groups was made 2 hours before surgery.
Preoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)
Time Frame: In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 2 hours before surgery.

Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device.

For experimental group The first evaluation was made before applying the progressive relaxation exercise(6.30 am).

For the control group The first evaluation was made 6.30am.
In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 2 hours before surgery.
Preoperative pulse rate (heart rate per minute) (1st. assessment)
Time Frame: In the preoperative period, the pulse rate was evaluated 2 hours before surgery.

Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter.

For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30 am).

For the control group The first evaluation was made 6.30am.
In the preoperative period, the pulse rate was evaluated 2 hours before surgery.
Preoperative respiratory rate (respiratory per minute) (1st. assessment)
Time Frame: In the preoperative period, respiratory rate was evaluated 2 hours before surgery.

Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute.

For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am).

For the control group The first evaluation was made 6.30am.
In the preoperative period, respiratory rate was evaluated 2 hours before surgery.
Preoperative body temperature (Celcius) (1st. assessment)
Time Frame: In the preoperative period, body temperature was evaluated 2 hours before surgery

Body temperature (Celcius)assessment was made with a digital thermometer. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am).

For the control group The first evaluation was made 6.30am.
In the preoperative period, body temperature was evaluated 2 hours before surgery
Preoperative oxygen saturation (SpO2) (1st. assessment)
Time Frame: In the preoperative period, oxygen saturation was evaluated 2 hours before surgery.

Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am).

For the control group The first evaluation was made 6.30am.
In the preoperative period, oxygen saturation was evaluated 2 hours before surgery.
Preoperative serum cortisol levels (1st. assessment)
Time Frame: In the preoperative period, serum cortisol levels assessment of the groups was made 2 hours before surgery.

Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory.

For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.45 am).

For the control group The first evaluation was made 6.45am.
In the preoperative period, serum cortisol levels assessment of the groups was made 2 hours before surgery.
Use of analgesic (See Table 1)(in the first 24 hours after surgery)
Time Frame: Analgesic consumption of the patients was recorded in the first 24 hours after surgery.
In this section, dose (mg) of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 0 Opioid NSAİ Other
Analgesic consumption of the patients was recorded in the first 24 hours after surgery.
Preoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)
Time Frame: In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 1 hour before surgery.

Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device.

For experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.).

For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 1 hour before surgery.
Preoperative pulse rate (heart rate per minute) (2nd. assessment)
Time Frame: In the preoperative period, the pulse rate was evaluated 1 hour before surgery.

Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute.

For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.).

For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
In the preoperative period, the pulse rate was evaluated 1 hour before surgery.
Preoperative respiratory rate (respiratory per minute) (2nd. assessment)
Time Frame: In the preoperative period, respiratory rate was evaluated 1 hour before surgery.

Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute.

For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.).

For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
In the preoperative period, respiratory rate was evaluated 1 hour before surgery.
Preoperative body temperature (Celcius) (2nd. assessment)
Time Frame: In the preoperative period, body temperature was evaluated 1 hour before surgery.

Body temperature (Celcius)assessment was made with a digital thermometer. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.).

For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
In the preoperative period, body temperature was evaluated 1 hour before surgery.
Preoperative oxygen saturation (SpO2) (2nd. assessment)
Time Frame: In the preoperative period, oxygen saturation was evaluated 1 hour before surgery.

Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.).

For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
In the preoperative period, oxygen saturation was evaluated 1 hour before surgery.
Preoperative serum cortisol levels (2nd. assessment)
Time Frame: In the preoperative period, serum cortisol levels assessment of the groups was made 1 hour before surgery.

Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory.

For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 45 minutes after the application (8.00am.).

For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 8.00am.
In the preoperative period, serum cortisol levels assessment of the groups was made 1 hour before surgery.
Use of analgesic (See Table 1)(postoperative 1st. day)
Time Frame: Analgesic consumption of the patients was recorded in the postoperative 1st. day.
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Doses (mg) Postoperative 1 Opioid NSAİ Other
Analgesic consumption of the patients was recorded in the postoperative 1st. day.
Use of analgesic (See Table 1)(postoperative 2nd day)
Time Frame: Analgesic consumption of the patients was recorded in the postoperative 2nd. day.
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 2 Opioid NSAİ Other
Analgesic consumption of the patients was recorded in the postoperative 2nd. day.
Use of analgesic (See Table 1)(postoperative 3rd day)
Time Frame: Analgesic consumption of the patients was recorded in the postoperative 3rd. days.
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 3 Opioid NSAİ Other
Analgesic consumption of the patients was recorded in the postoperative 3rd. days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative pain severity
Time Frame: Postoperative pain assessment of the groups was made postoperative 3rd. day.

Pain severity assessment with Short Form McGill Pain Questionnaire

For the experimental group The pain assessment of the experimental group in the postoperative period was made on the 3rd day after surgery. This evaluation was made 1 hour after the progressive relaxation exercise on the 3rd postoperative day (8.30 am).

For the control group Postoperative pain assessment of the control group was made on the 3rd day after surgery.

Postoperative pain assessment of the control group was made on the 3rd day after surgery. Post-operative pain assessment of the control group was performed at the same time (8.30 am) to ensure intergroup equivalence.
Postoperative pain assessment of the groups was made postoperative 3rd. day.
Postoperative anxiety severity
Time Frame: Postoperative anxiety assessment of the groups was made postoperative 3rd. day.

Anxiety severity with Spielberger's State and Trait Anxiety Inventory State Anxiety Subscale are specified by choosing one of the options "1) not at all, 2) somewhat, 3) moderately so, and 4) very much so" according to the severity of such experiences.

Anxiety assessment for the experimental group The anxiety assessment of the experimental group in the postoperative period was made on the 3rd day after surgery. This evaluation was made 1 hour after the progressive relaxation exercise on the 3rd postoperative day (8.30 am).

Anxiety assessment for the control group Postoperative anxiety assessment of the control group was made on the 3rd day after surgery.

Postoperative anxiety assessment of the control group was made on the 3rd day after surgery. Post-operative anxiety assessment of the control group was performed at the same time (8.30 am) to ensure intergroup equivalence.
Postoperative anxiety assessment of the groups was made postoperative 3rd. day.
Postoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)
Time Frame: Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 1st. day.

Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device.

For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 1st. day.
Postoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)
Time Frame: Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 2nd. day.

Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device.

For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 2nd. day.
Postoperative systolic and diastolic blood pressure (mmHg) (3rd. assessment)
Time Frame: Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 3rd. day.

Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device.

For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 3rd. day.
Postoperative pulse rate (heart rate per minute) (1st. assessment)
Time Frame: Pulse rate (heart rate per minute) evaluation was made on postoperative 1st. day.

Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter.

For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Pulse rate (heart rate per minute) evaluation was made on postoperative 1st. day.
Postoperative pulse rate (heart rate per minute) (2nd. assessment)
Time Frame: Pulse rate (heart rate per minute) evaluation was made on postoperative 2nd. day.

Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter.

For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Pulse rate (heart rate per minute) evaluation was made on postoperative 2nd. day.
Postoperative pulse rate (heart rate per minute) (3rd. assessment)
Time Frame: Pulse rate (heart rate per minute) evaluation was made on postoperative 3rd. day.

Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter.

For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Pulse rate (heart rate per minute) evaluation was made on postoperative 3rd. day.
Postoperative respiratory rate (respiratory per minute) (1st. assessment)
Time Frame: Respiratory rate (respiratory per minute) evaluations was made on postoperative 1st. day.

Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute.

For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Respiratory rate (respiratory per minute) evaluations was made on postoperative 1st. day.
Postoperative respiratory rate (respiratory per minute) (2nd. assessment)
Time Frame: Respiratory rate (respiratory per minute) evaluations was made on postoperative 2nd. day.

Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute.

For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Respiratory rate (respiratory per minute) evaluations was made on postoperative 2nd. day.
Postoperative respiratory rate (respiratory per minute) (3rd. assessment)
Time Frame: Respiratory rate (respiratory per minute) evaluations was made on postoperative 3rd. day.

Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute.

For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Respiratory rate (respiratory per minute) evaluations was made on postoperative 3rd. day.
Postoperative body temperature (celcius) (1st. assessment)
Time Frame: Body temperature (0C) evaluation was made on postoperative 1st. day.
Body temperature (celcius)assessment was made with a digital thermometer. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Body temperature (0C) evaluation was made on postoperative 1st. day.
Postoperative body temperature (celcius) (2nd. assessment)
Time Frame: Body temperature (0C) evaluation was made on postoperative 2nd. day.
Body temperature (celcius)assessment was made with a digital thermometer. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Body temperature (0C) evaluation was made on postoperative 2nd. day.
Postoperative body temperature (celcius) (3rd. assessment)
Time Frame: Body temperature (0C) evaluation was made on postoperative 3rd. day.
Body temperature (celcius)assessment was made with a digital thermometer. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Body temperature (0C) evaluation was made on postoperative 3rd. day.
Postoperative oxygen saturation (SpO2) (1st. assessment)
Time Frame: Oxygen saturation (SpO2) evaluation was made on postoperative 1st. day.
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Oxygen saturation (SpO2) evaluation was made on postoperative 1st. day.
Postoperative oxygen saturation (SpO2) (2nd. assessment)
Time Frame: Oxygen saturation (SpO2) evaluation was made on postoperative 2nd. day.
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Oxygen saturation (SpO2) evaluation was made on postoperative 2nd. day.
Postoperative oxygen saturation (SpO2) (3rd. assessment)
Time Frame: Oxygen saturation (SpO2) evaluation was made on postoperative 3rd. day.
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Oxygen saturation (SpO2) evaluation was made on postoperative 3rd. day.
Postoperative serum cortisol levels (1st. assessment)
Time Frame: In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 1st. day.

Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory.

For the experimental group The first day evaluation was made 45 minutes after applying the progressive relaxation exercise (8.00 am).

For the control group The first day evaluation was made 8.00 am. Progressive relaxation exercise wasn't applied because of was control group.
In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 1st. day.
Postoperative serum cortisol levels (2nd. assessment)
Time Frame: In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 2nd. day.

Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory.

For the experimental group The second day evaluation was made 45 minutes after applying the progressive relaxation exercise (8.00 am).

For the control group The second day evaluation was made 8.00 am. Progressive relaxation exercise wasn't applied because of was control group.
In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 2nd. day.
Postoperative serum cortisol levels (3rd. assessment)
Time Frame: In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 3rd. day.

Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory.

For the experimental group The third day evaluation was made 45 minutes after applying the progressive relaxation exercise (8.00 am).

For the control group The third day evaluation was made 8.00 am. Progressive relaxation exercise wasn't applied because of was control group.
In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 3rd. day.

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
YASEMİN ÖZHANLI

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nuray Akyüz, Assoc. Prof., Istanbul University - Cerrahpasa (IUC)
  • Study Chair: Yasemin Özhanlı, PhD, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

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General Publications

Study record dates

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Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2020

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First Submitted

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January 15, 2021

First Submitted That Met QC Criteria

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January 28, 2021

First Posted (ACTUAL)

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February 1, 2021

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February 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

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January 28, 2021

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January 1, 2021

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Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/141525

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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