The Effect Of Relaxation Exercises Before Cataract Surgery on Elderly İndividuals

February 15, 2023 updated by: Mehmet Ata Demir, Istanbul University - Cerrahpasa (IUC)

The Effect Of Relaxation Exercises Before Cataract Surgery On The Anxiety Level Of Elderly İndividuals

The aim of this study was to determine the effect of relaxation exercises applied before cataract surgery on the anxiety level of elderly individuals.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The study was planned as a randomized controlled study to determine the effect of relaxation exercises applied before cataract surgery on the anxiety level of elderly individuals. In this context, as a result of the study, it will be concluded about the effect of relaxation exercises applied before cataract surgery on the anxiety level of elderly individuals. It is also aimed to evaluate the effect of relaxation exercises on the preoperative and intraoperative vital signs of elderly individuals and their satisfaction level with the intervention.

Patients who meet the inclusion criteria will be informed about the purpose, content and method of the study during patient admission in the preoperative period, and the sample group (experimental and control) will be formed by obtaining written permission from those who voluntarily agree to participate in the study. The determination of the experimental and control groups will be provided by the random numbers generated by the https://www.randomizer.org/ website. In the sample group (experimental, control), a pilot study will be conducted to evaluate the applicability of the study plan before the implementation (10 experimental, 10 control). In addition, the researcher will explain the application of relaxation exercises within the scope of the research to the patients in the experimental group by accepting the intervention application in the preoperative period.

Formation of the Experimental Group and Interventions:

  • First, patients who meet the sample selection criteria will be identified.
  • Standardized Mini Mental Test will be administered to patients who are eligible for the study. Patients with a score of 25 and above will be informed about the purpose, content and method of the study by reading the voluntary information form, and those who voluntarily agree to participate in the study and accept the intervention will be included in the study by obtaining verbal and written consent. According to the order of inclusion in the study, the experimental group will be formed from the numbers generated by the https://www.randomizer.org/ website.
  • Cataract surgery (phacoemulsification) is usually performed on a daily basis. In this period, firstly, the Information Form will be applied to the patients. Then, preoperative State-Trait Anxiety Inventory and Visual Comparison Scale will be used to determine anxiety levels and vital signs will be evaluated.
  • The non-pharmacologic relaxation exercise method will be explained to the patient by the researcher.
  • In order to ensure that the 30-minute relaxation exercises can be performed in a comfortable environment, the patient can relax sufficiently, and the patients can make independent decisions in anxiety assessments; care will be taken to ensure that the patient's relatives are not present in the room, the curtain / screen on the patient's bed is closed, there is no urgency for urinary and bowel evacuation, the CD volume is adjusted according to the patient's preference, and the room is quiet and calm. An eye patch will be used during this period to minimize environmental factors.
  • Immediately after the intervention, the State Anxiety Inventory and Visual Comparison Scale will be used to measure the individual's anxiety, satisfaction level with the intervention and vital signs will be evaluated.
  • When the individual arrives at the operating room, his/her anxiety level and vital signs will be assessed in the waiting room using the State Anxiety Inventory and Visual Comparison Scale. During the operation, vital signs will be monitored on the monitor at 5 minute intervals. The interpretation of vital signs during the operation will be based on the average value of the measurements.

Relaxation Exercises Practice:

  • Relaxation exercises consist of voluntary, rhythmic and regular stretching and relaxation of large and small muscle groups until the whole body relaxes. For this exercise application; "Relaxation Exercises CD" prepared by the Turkish Psychologists Association will be used.
  • The CD consists of 3 parts. In the first part, the definition and purpose of 10 minutes of deep relaxation and the practices to be considered during the exercise are explained. The second part consists of 30 minutes and explains relaxation exercises with the sound of a stream accompanied by verbal instructions. The 3rd part consists of 30 minutes and includes only relaxation music without instructions.
  • In this study, only the second part of the "Relaxation Exercises CD" will be used and it will be applied in the patient's room/bed by the researcher by using a portable VCD/DVD player, adjusting the volume according to the patient's preference, with the help of headphones, taking into account the institutional policy in the preoperative period.

The elderly individuals in the control group will be measured in the same time period as the experimental group without any intervention.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • 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
    • Beyoğlu
      • Istanbul, Beyoğlu, Turkey
        • Beyoglu Eye Training and Research 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

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 65 years of age or older,
  • At least be able to read and write,
  • No problems in terms of hearing, communication (verbal / non-verbal),
  • Can communicate in Turkish,
  • Mini Mental State Examination Test score of 25 points and above,
  • First time cataract surgery under planned topical/local anesthesia.

Exclusion Criteria:

  • Lacking cognitive competence,
  • Additional eye problems other than cataracts,
  • According to the STAI, with additional anxiety problems other than surgery,
  • Known psychiatric problems,
  • Developing complications during surgery,
  • Elderly individuals who have to undergo different anesthesia will not be included in the study.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Elderly individuals undergoing relaxation exercises before cataract surgery
Procedure: Relaxation Exercises
Relaxation exercises consist of voluntary, rhythmic and regular stretching and relaxation of large and small muscle groups until the whole body relaxes. For this exercise application, the "Relaxation Exercises CD" prepared by the Turkish Psychological Association will be used. The CD consists of 30 minutes and relaxation exercises are explained with the sound of a stream accompanied by verbal instructions. This exercise includes rhythmic breathing, muscle relaxation exercises and music (stream sound).
No Intervention: Control Group
Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in STAI-S's Inventory
Time Frame: before and immediately after the relaxation exercise and before surgery (in the operating room waiting room)
State anxiety (STAI-S) refers to a temporary emotional state related to a specific situation. The STAI -S consists of 20 items. The total score obtained from the scale is between 20-80 and an increase in the score indicates an increase in the level of anxiety. The validity and reliability of the Turkish versions of these instruments have been validated.
before and immediately after the relaxation exercise and before surgery (in the operating room waiting room)
STAI-T's Inventory
Time Frame: before the relaxation exercise
Trait anxiety (STAI-T) represents anxiety as a stable personality character. The STAI -T consists of 20 items. The total score obtained from the scale is between 20-80 and an increase in the score indicates an increase in the level of anxiety. The validity and reliability of the Turkish versions of these instruments have been validated.
before the relaxation exercise
Change in Anxiety as Measured by Visual Analog Scale (VAS-A)
Time Frame: before and immediately after the relaxation exercise, in the operating room waiting room and immediately before surgery.
Measured using the Visual Analogue Scale for Anxiety (VAS-A), on a scale of 0 to 10, in which a higher score means an increased level of anxiety
before and immediately after the relaxation exercise, in the operating room waiting room and immediately before surgery.
Change in Blood Pressure
Time Frame: before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery
A calibrated digital sphygmomanometer will be used to measure blood pressure. Results will be reported in mmHg.
before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery
Change in Pulse Rate
Time Frame: before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery
Calibrated digital finger type pulse oximeter will be used for pulse measurement. The results presented as beat per minute.
before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery
Change in Respiratory Rate
Time Frame: before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery
Respiratory rate per minute. Higher scores mean a worse result.
before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery
Change in Peripheral Oxygen Saturation (SpO2)
Time Frame: before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery
Calibrated digital finger type pulse oximeter will be used for Peripheral Oxygen Saturation (SpO2). Approaching 100% is considered positive. Higher scores mean a better result.
before and immediately after the relaxation exercise, in the operating room waiting room, immediately before surgery and during surgery
Change in Body Temperature
Time Frame: before and immediately after the relaxation exercise, in the operating room waiting room (before surgery )
A calibrated non-contact infrared thermometer will be used to measure body temperature. Results will be reported in Celcius.
before and immediately after the relaxation exercise, in the operating room waiting room (before surgery )

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Satisfaction as Measured by Visual Analog Scale
Time Frame: before and immediately after the relaxation exercise
Measured using the Visual Analogue Scale for Satisfaction, on a scale of 0 to 10, in which a higher score means an increased level of satisfaction
before and immediately after the relaxation exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-48670771-514.99

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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