Clinical trial NCT06749626: Progressive Relaxation Exercises Applied After Laparoscopic Cholecystectomy Surgery; Pain Intensity, Physiological Parameters, Anxiety and Its Effect on Discharge
Official title: Progressive Relaxation Exercises Applied After Laparoscopic Cholecystectomy Surgery; Pain Intensity, Physiological Parameters, Anxiety and Its Effect on Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cholecystectomy Surgery
Keywords: pain
anxiety
physiological parameters
laparoscopic cholecystectomy
progressive relaxation exercise
discharge
Lead sponsor: Bartın Unıversity
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale- VAS
timeFrame: For the experimental group, before the progressive relaxation exercise and after the progressive relaxation exercise applied at the 6th and 10th hours, for the control group, before the 6th hour without the progressive relaxation exercise, at the 6th and
measure: State-Trait Anxiety Scale
timeFrame: For the experimental group, before the progressive relaxation exercise and after the progressive relaxation exercise applied at the 6th and 10th hours, for the control group, before the 6th hour without the progressive relaxation exercise, at the 6th and
measure: Discharge Readiness Scale
timeFrame: It will be applied to patients in both groups the day after surgery.
measure: Physiological Parameters Monitoring Form
timeFrame: For the experimental group, before the progressive relaxation exercise and after the progressive relaxation exercise applied at the 6th and 10th hours, for the control group, before the 6th hour without the progressive relaxation exercise, at the 6th and
measure: Data Collection Form
timeFrame: The Data Collection Form will be filled out at least 1 hour before the surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Bartın
country: Turkey
facility: Bartin State Hospital
state: Merkez
Study officials:
References: