Progressive Relaxation Exercises Applied After Laparoscopic Cholecystectomy Surgery; Pain Intensity, Physiological Parameters, Anxiety and Its Effect on Discharge

NCT ID: NCT06749626

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-23

Study Completion Date

2024-09-18

Brief Summary

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INTRODUCTION: Among gastrointestinal system diseases, gallbladder diseases are the most common. As is the case after every surgical intervention, changes occur in the patient's homeostasis after laparoscopic cholecystectomy surgery. Studies have shown that more than half of the patients experience moderate to severe pain in the postoperative period. In addition, postoperative pain negatively affects the patients' quality of life by reducing their comfort levels. Progressive relaxation exercises, one of the cognitive-behavioral techniques, aim to gradually contract and relax the patients' muscles. Progressive relaxation exercises; It provides stabilization in physiological parameters by reducing pain caused by muscle tension and increased sympathetic activity after surgery.

At the end of this initiative, it is anticipated that the patient's comfort and satisfaction will increase, the healing process will accelerate, the duration of hospital stay will decrease and, accordingly, hospital care costs will decrease.

PURPOSE: The aim of the thesis study is to determine the progressive relaxation exercises applied after laparoscopic cholecystectomy surgery; To evaluate pain intensity, physiological parameters, anxiety and its effect on discharge.

METHOD: Planned as a randomized controlled experimental study, patients who underwent laparoscopic cholecystectomy surgery at Bartın State Hospital General Surgery Clinic were evaluated according to the algorithm created by the computer program (https://www.randomizer.org/) using numbers from 1 to 102. It will be randomly divided into 2 blocks. A two-block randomization will be made, the first block will be determined as the control group and the second block will be determined as the experimental group. There will be 104 patients in total, 52 in each group. In addition to routine treatment, patients in the experimental group will receive progressive relaxation exercises at the 6th and 10th hour after surgery. After the application, the effect of changes on the patients' pain, physiological parameters, anxiety and discharge will be recorded. 'Data Collection Form', 'Visual Comparison Scale (VAS)', 'Physiological Parameters Monitoring Form', 'State-Trait Anxiety Scale' and 'Readiness for Discharge Scale' will be used to collect data. The analysis of the collected data will be evaluated using the SPSS for Windows 22 program.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy Surgery

Keywords

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pain anxiety physiological parameters laparoscopic cholecystectomy progressive relaxation exercise discharge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group undergoing progressive relaxation exercise after laparoscopic cholecystectomy surgery

Progressive relaxation exercises lasting approximately 30 minutes were applied to the patients in the experimental group, accompanied by the researcher, at the 6th hour, when the nonsteroidal anti-inflammatory drug administered by the clinic was half-done, and at the 10th hour after the surgery.

Group Type EXPERIMENTAL

progressive relaxation exercise

Intervention Type OTHER

Relaxation exercises CD developed by the Turkish Psychologists Association; It consists of muscle exercises, rhythmic breathing and music recital. The CD content, which includes relaxation exercises accompanied by music, was prepared by Psychologist Elif Kabak and voiced by Tülay Bursa. The CD, which includes deep breathing and muscle relaxation exercises, consists of three parts. The first section includes the definition of deep relaxation, the purpose of relaxation exercises and the rules to be considered in exercise practice. In the second part; There are relaxation exercises with audio instructions accompanied by streaming sounds. The third part contains relaxation music without instructions. After the information in the first part of the CD is explained to the patients in the experimental group, the second part, which lasts only approximately 30 minutes, will be administered under the supervision of the researcher. However, since the patients have undergone abdominal surgery, the

Group without progressive relaxation exercise after laparoscopic cholecystectomy surgery

Patients in the control group were treated only according to the clinical analgesia protocol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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progressive relaxation exercise

Relaxation exercises CD developed by the Turkish Psychologists Association; It consists of muscle exercises, rhythmic breathing and music recital. The CD content, which includes relaxation exercises accompanied by music, was prepared by Psychologist Elif Kabak and voiced by Tülay Bursa. The CD, which includes deep breathing and muscle relaxation exercises, consists of three parts. The first section includes the definition of deep relaxation, the purpose of relaxation exercises and the rules to be considered in exercise practice. In the second part; There are relaxation exercises with audio instructions accompanied by streaming sounds. The third part contains relaxation music without instructions. After the information in the first part of the CD is explained to the patients in the experimental group, the second part, which lasts only approximately 30 minutes, will be administered under the supervision of the researcher. However, since the patients have undergone abdominal surgery, the

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Volunteer to participate in the research,
* No visual or auditory problems,
* Able to speak and understand Turkish,
* No diagnosed psychiatric problems,
* No complications such as bleeding, nausea or vomiting after laparoscopic cholecystectomy surgery,
* Not using patient-controlled analgesia and opioids for postoperative pain control,
* Patients with a pain score ≥4 according to the Visual Comparison Scale will be included.

Exclusion Criteria

* Those who do not volunteer to participate in the research,
* Having visual or auditory problems,
* Those who cannot speak or understand Turkish,
* Having a diagnosed psychiatric problem,
* Complications such as bleeding, nausea and vomiting occur after laparoscopic cholecystectomy surgery,
* Using patient-controlled analgesia and opioids for postoperative pain control,
* Patients with a pain score \<4 according to the Visual Comparison Scale will not be included.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bartın Unıversity

OTHER

Sponsor Role lead

Responsible Party

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Buse Dinçer

Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bartin State Hospital

Bartın, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BartınU- SBF- BD- 01

Identifier Type: -

Identifier Source: org_study_id