The Effect Of Machine-Based And Manually Applied Hand Massage On Pain, Anxiety And Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

December 2, 2022 updated by: Münevver Şengül

Introduction: As after almost every surgical procedure, changes in the patient's system functions, acute pain and an increase in anxiety level occur after laparoscopic cholecystectomy. Uncontrolled pain and anxiety slows down the healing process, increases the possibility of opioid use and the risk of undesirable side effects, and increases mortality, and prolongs hospital discharge.

Objective: The aim of the thesis study is to evaluate the effect of machine-based and manual hand massage applied in the postoperative period on pain, anxiety and gastrointestinal system functions in patients who have undergone laparoscopic cholecystectomy.

Method: In the study planned as a randomized controlled experimental study; There will be 3 groups, 57 patients in each group, including the experimental groups and the control group, who have undergone laparoscopic cholecystectomy and hospitalized in the General Surgery Clinic of Bartın State Hospital, where machine-based and manual hand massage will be applied. In addition to the analgesic treatment requested by the physician at the 0th, 4th and 8th hours after the surgery, the experimental groups will be given 10 minutes of hand massage to each hand, and only the requested treatment will be applied to the control group. After the applications, the changes in the pain and anxiety levels of the patients as well as the effects on the gastrointestinal system functions will be recorded. 'Data Collection Form', 'Numerical Rating Scale', 'State-Trait Anxiety Scale' and 'Gastrointestinal functions monitoring form' will be used to collect the data and the data will be analyzed in SPSS 22.0 program.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

As with almost every surgical procedure, changes in the patient's system functions, acute pain and an increase in anxiety level occur after laparoscopic cholecystectomy. Uncontrolled pain and anxiety slows down the healing process, increases the possibility of opioid use and the risk of undesirable side effects, and increases mortality, and prolongs hospital discharge. Massage; increases patient comfort, relaxation and satisfaction and reduces stress. Receptors associated with nerve fibers that transmit pain to the brain are mostly found in the feet and hands. For this reason, the effect of hand massage was wanted to be examined.

The aim of the thesis study is to evaluate the effect of manual and machine-based application of hand massage on pain, anxiety and GIS functions after laparoscopic cholecystectomy. In the study planned as a randomized controlled experimental study; There will be 3 groups, 57 patients in each group, including the experimental groups and the control group, who have undergone laparoscopic cholecystectomy and hospitalized in the General Surgery Clinic of Bartın State Hospital, where machine-based and manual hand massage will be applied.

First, the researcher will receive certified training on hand massage. Necessary permissions will be obtained to carry out the research. Patients who have undergone laparoscopic cholecystectomy in the general surgery service of Bartın state hospital and meet the inclusion criteria will be divided into 3 groups, 2 experimental and 1 control group, by block randomization. Before starting the application, the purpose of the research will be explained by the researcher and the informed consent of the individuals will be obtained. Data will be collected between September 2022 and June 2023. The patient will fill in the 'Section 1 of the Data Collection Form' and the 'Trait Anxiety Scale' at least 1 hour before the surgery in the preoperative period. The second part will be filled at the most appropriate time after the surgery. When the patient comes to the service after the surgery, before the first hour is up, that is, at the 0th hour and at the 4th and 8th hours, a hand massage device will be used and manual hand massage will be applied in addition to the treatment according to the clinical analgesia protocol, and hand massage will be applied for 10 minutes for each hand. The control group will be treated only according to the clinical analgesia protocol. Before the massage and after the massage at 0, 4 and 8 hours; On the other hand, the 'Numerical Rating Scale', State Anxiety Scale' will be applied to the control group during the periods when other groups are massaged without hand massage, and the 'Gastrointestinal Functions Monitoring Form' will be filled.

All these evaluation stages will be done in the form of dividing 171 patients into 3 groups and evaluating them sequentially by numbering.

Application of manual hand massage: The researcher will receive certified training on hand massage. Hand massage application method will be determined after the training.

Application of machine-based hand massage: The pressure of the machine will be adjusted according to the manual massage application method. In manual massage and machine massage, machine adjustments will be made to keep the temperature and pressure difference as low as possible.

Study Type

Interventional

Enrollment (Anticipated)

171

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
      • Bartın, Turkey, 74100
        • Bartin universty

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years and over,
  • Having undergone laparoscopic cholecystectomy,
  • No complications after laparoscopic cholecystectomy,
  • Receiving analgesia treatment according to the clinical protocol,
  • Pain score >4 according to the Numerical Rating Scale,
  • Able to speak and understand Turkish
  • No visual or auditory problems,
  • No diagnosed psychiatric problem,
  • No diagnosed gastrointestinal problem,
  • Voluntary patients will be included.

Exclusion Criteria:

  • Having undergone open cholecystectomy,
  • Complications after laparoscopic cholecystectomy,
  • Pain score ≤4 according to the Numerical Rating Scale,
  • Using analgesic drugs or methods other than clinical protocol,
  • Having visual or auditory problems,
  • Having a diagnosed psychiatric problem,
  • Diagnosed gastrointestinal problem,
  • Patients with contagious skin disease (such as zoster, fungus, wart, eczema) on their hands, presence of thrombosis or phlebitis, any fracture, ligament injury,
  • Non-voluntary patients will be excluded.

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manuel hand massage group
According to the hand massage training received, the patient coming out of the surgery is in diamond shape for ten minutes for each hand.
Other: Manual hand massage after laparoscopic cholecystectomy surgery
Manual hand massage is applied to a group of patients at 0, 4 and 8 hours after the patient returns from laparoscopic cholecystectomy surgery. It is applied to each hand for ten minutes.
Experimental: machine-based hand massage
The pressure setting of the machine is made according to the manual massage application method. In manual massage and machine massage, machine adjustments are made to keep the temperature and pressure difference as low as possible. A hand massage is done for ten minutes for each hand.
Other: Machine-based hand massage after laparoscopic cholecystectomy surgery
Machine-based hand massage is applied to a group of patients at 0, 4 and 8 hours after the patient returns from laparoscopic cholecystectomy surgery. It is applied to each hand for ten minutes.
No Intervention: Control group
The control group will be treated only according to the clinical analgesia protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time Frame: It will be evaluated using the numerical rating scale (NRS) before the massage. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
To see the effect of manual hand massage
It will be evaluated using the numerical rating scale (NRS) before the massage. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time Frame: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 0th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
To see the effect of manual hand massage
It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 0th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time Frame: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 4th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
To see the effect of manual hand massage
It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 4th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time Frame: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 8th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
To see the effect of manual hand massage
It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 8th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time Frame: It will be evaluated using the numerical rating scale (NRS) before the massage. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
To see the effect of machine-based hand massage
It will be evaluated using the numerical rating scale (NRS) before the massage. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time Frame: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 0th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
To see the effect of machine-based hand massage
It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 0th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time Frame: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 4th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
To see the effect of machine-based hand massage
It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 4th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time Frame: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 8th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
To see the effect of machine-based hand massage
It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 8th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time Frame: Immediately after surgery, it will be evaluated using the numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
assessing patients who are not massaged (control group)
Immediately after surgery, it will be evaluated using the numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time Frame: After surgery at 0 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
assessing patients who are not massaged (control group)
After surgery at 0 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time Frame: After surgery at 4 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I
assessing patients who are not massaged (control group)
After surgery at 4 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time Frame: After surgery at 8 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I
assessing patients who are not massaged (control group)
After surgery at 8 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: The State Anxiety Scale is used. The State Anxiety Scale will be used immediately after the surgery and before the massage to be performed at the 0th hour.
To see the effect of manual hand massage on state anxiety level
The State Anxiety Scale is used. The State Anxiety Scale will be used immediately after the surgery and before the massage to be performed at the 0th hour.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 0th hour after the surgery.
To see the effect of manual hand massage on state anxiety level
The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 0th hour after the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 4th hour after the surgery.
To see the effect of manual hand massage on state anxiety level
The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 4th hour after the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 8th hour after the surgery.
To see the effect of manual hand massage on state anxiety level
The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 8th hour after the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.
To see the effect of manual hand massage on trait anxiety level
The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: The State Anxiety Scale is used. The State Anxiety Scale will be used immediately after the surgery and before the massage to be performed at the 0th hour.
To see the effect of machine-based hand massage on state anxiety level
The State Anxiety Scale is used. The State Anxiety Scale will be used immediately after the surgery and before the massage to be performed at the 0th hour.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 0th hour after the surgery.
To see the effect of machine-based hand massage on state anxiety level
The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 0th hour after the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 4th hour after the surgery.
To see the effect of machine-based hand massage on state anxiety level
The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 4th hour after the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 8th hour after the surgery.
To see the effect of machine-based hand massage on state anxiety level
The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 8th hour after the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.
To see the effect of machine-based hand massage on trait anxiety level
The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: Immediately after surgery the State Anxiety Scale is used.
Evaluation of state anxiety level of patients who were not massaged (control group)
Immediately after surgery the State Anxiety Scale is used.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: After surgery at 0th hour the State Anxiety Scale is used.
Evaluation of state anxiety level of patients who were not massaged (control group)
After surgery at 0th hour the State Anxiety Scale is used.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: After surgery at 4th hour the State Anxiety Scale is used.
Evaluation of state anxiety level of patients who were not massaged (control group)
After surgery at 4th hour the State Anxiety Scale is used.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: After surgery at 8th hour the State Anxiety Scale is used.
Evaluation of state anxiety level of patients who were not massaged (control group)
After surgery at 8th hour the State Anxiety Scale is used.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time Frame: The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.
Evaluation of trait anxiety level of patients who were not massaged (control group)
The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time Frame: The form of monitoring of gastrointestinal functions is used. Before the massage, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of manual hand massage
The form of monitoring of gastrointestinal functions is used. Before the massage, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time Frame: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of manual hand massage
The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time Frame: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of manual hand massage
The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time Frame: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of manual hand massage
The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time Frame: The form of monitoring of gastrointestinal functions is used. Before the massage, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of machine-based hand massage
The form of monitoring of gastrointestinal functions is used. Before the massage, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time Frame: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of machine-based hand massage
The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time Frame: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of machine-based hand massage
The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time Frame: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of machine-based hand massage
The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time Frame: immediately after surgery, it will be evaluated using a The form of monitoring of gastrointestinal functions.
assessing patients who are not massaged (control group)
immediately after surgery, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time Frame: After surgery at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
assessing patients who are not massaged (control group)
After surgery at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time Frame: After surgery at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
assessing patients who are not massaged (control group)
After surgery at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time Frame: After surgery at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
assessing patients who are not massaged (control group)
After surgery at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.

Collaborators and Investigators

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

Sponsor

Münevver Şengül

Collaborators

Bartin State Hospital

Investigators

  • Principal Investigator: Münevver Şengül, mnvvrsngll58@gmail.com
  • Study Director: Sevim Çelik, sevimakcel@yahoo.com

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)

October 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-SBB-0329

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

product manufactured in and exported from the U.S.

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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