The Effect of Progressive Relaxation Exercises on Bariatric Surgery Period

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to test the effect of the progressive relaxation exercises in perioperative bariatric surgery patient care. The investigators know that the preoperative anxiety is an important factor that affects acute postoperative pain experience. Additionally, the investigators know that there is a relationship between preoperative anxiety and moderate to severe pain in the first 12 hours postoperatively, and this is also true for patients undergoing bariatric surgery. The main questions it aims to answer are: Does preoperative anxiety level of patient who will undergo bariatric surgery and who are applied progressive relaxation exercises is lower than those who did not apply exercise? Does postoperative pain level of patient who underwent bariatric surgery and applied progressive relaxation exercises was lower than patients who did not apply exercise? Participants will be randomly split into two groups and one of the groups of participants will learn how to do progressive relaxation exercises preoperatively and the other group will learn nothing. Then at the time of the surgery, all participants will fill a survey preoperatively to analyze participants' anxiety level in each group and the investigators will collect data about participants' pain level postoperatively. Researchers will compare these data whether there is an effect of the progressive relaxation exercises on preoperative anxiety and postoperative pain or not.

Detailed Description
-----------------
Preoperative anxiety is a defined factor that affects the acute postoperative pain experience. There is an evidence-based relationship between preoperative anxiety and moderate to severe pain in the first 12 hours postoperatively. Similarly, patients with high anxiety before bariatric surgery experienced more pain in the first postoperative hour. Interventions to reduce anxiety may decrease the surgical pain response and improve postoperative recovery by reducing the sympathetic nervous system response. There are various pharmacological and non-pharmacological methods (such as education, music, acupuncture, massage) used for preoperative anxiety. One of the non-pharmacological methods is progressive relaxation exercises. Progressive muscle relaxation is a relaxation technique developed by Edmund Jacobson in the 1920s. It is one of the simple and easy to learn relaxation techniques. These exercises involve contracting muscles to create tension and gradually releasing that tension. It is routinely repeated until complete relief is achieved. In the literature, there are studies on the effect of progressive relaxation exercises on anxiety and pain. In these studies, it was determined that progressive relaxation exercises reduce anxiety, pain, muscle tension, sleep disorders and fatigue levels. No study has been found on the effect of progressive relaxation exercises on preoperative anxiety and postoperative pain in bariatric surgery patients. So, the investigators planned a study to determine the effect of progressive relaxation exercises on preoperative anxiety and postoperative pain in patients undergoing bariatric surgery. Patients willing to have a bariatric surgery in our hospital will be split into two groups randomly and one of the groups of participants will be learnt how to do progressive relaxation exercises one month preoperatively and the other group will learn nothing. Then at the time of the surgery, all patients will fill a survey preoperatively to collect the participants' anxiety level in each group and pain scores will be collected postoperatively. All patients will give informed consent to join to the study. H1: Preoperative anxiety level of patients who will undergo bariatric surgery and who are applied progressive relaxation exercises is lower than those who do not exercise. H2: Postoperative pain level of patients who underwent bariatric surgery and applied progressive relaxation exercises was lower than patients who did not apply exercise. Study arms are explained below.

Official Title
-----------------
The Effect of Progressive Relaxation Exercises on Preoperative Anxiety and Postoperative Pain in Bariatric Surgery Patients

Conditions
-----------------
Obesity, Morbid, Bariatric Surgery Candidate, Anxiety, Postoperative Pain

Intervention / Treatment
-----------------
* Behavioral: Progressive relaxation exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having bariatric surgery plan (such as sleeve gastrectomy, gastric bypass), 18 years and over, Do not have any medically diagnosed health problems (neurological, psychiatric, orthopedic) that will prevent learning and practicing progressive muscle relaxation exercises, Agreeing to apply progressive relaxation exercises, willing and willing to participate in the study, Patients who do not know and practice progressive relaxation exercises before will be included in the study. Exclusion Criteria: Patients younger than 18 and older than 65, Patients who do not want to apply progressive relaxation exercises, who do not apply them as desired during the study period, who have health problems (neurological, psychiatric, orthopedic) that may affect their ability to do the exercises will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progressive relaxation exercises group<br>Participants will be randomly selected by a computer based system (Block randomization was used to keep the sample size of the groups similar. Random Allocation Software (Ver. 1.0.0) will be used to allocate the patients to groups). Selected participants will be invited to a meeting which will be held face-to-face and in a quiet environment. Progressive Relaxation Exercises will be explained to this group in a step-by-step manner whose surgery date is determined to undergo bariatric surgery by the relevant researcher. After this stage, participants will be followed to do the exercises regularly for a month by a researcher. Patients will fill the Amsterdam Preoperative Anxiety and Information Score Scale preoperatively at the hospital. After the surgery, the patients will be evaluated by the researchers in terms of pain scores and analgesic usage frequency in the recovery room and 1st, 4th, 8th, 12th, 24th, 36th and 48th hours data will be collected in the postoperative service. | Behavioral: Progressive relaxation exercises<br>* Training booklet and CD as a guide on the implementation of Progressive Relaxation Exercises prepared by the Turkish Psychological Association; muscle relaxation exercises, rhythmic breathing and music recital. In the first 10 minutes of this three-part CD, the definition and purpose of deep relaxation and the practices to be considered during exercise are explained. In the second part of 30 minutes; relaxation exercises are explained with the sound of the stream and verbal instructions. The third part, consisting of 30 minutes; it contains only relaxation music without instructions.<br>|
| No Intervention: Control group<br>This group will be the randomized selected patients who will not get any intervention. Patients will fill the Amsterdam Preoperative Anxiety and Information Score Scale preoperatively at the hospital. After the surgery, the patients will be evaluated by the researchers in terms of pain scores and analgesic usage frequency in the recovery room and 1st, 4th, 8th, 12th, 24th, 36th and 48th hours data will be collected in the postoperative service. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative anxiety level | The Progressive relaxation exercises supposed to lower the preoperative anxiety level in bariatric surgery patients. The patients will fill the Amsterdam Preoperative Anxiety and Information Score Scale preoperatively. The Amsterdam Preoperative Anxiety and Information Scale is a self-report questionnaire composed of six questions that were developed and validated to evaluate a patient's preoperative anxiety. The range of the scale is between 6 to 30 and higher means more anxiety. | Preoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain level | Progressive relaxation exercises supposed to lower the postoperative pain scores in the bariatric surgery patients. The pain score will be identified by using the visual analog scale (VAS) score. VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. The range of the scale is between 0 to 10 and higher means more pain. | Postoperative pain scores collection is planned at the postoperative period in the first 48 hour after the surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bariatric surgery, Progressive relaxation exercises, anxiety, postoperative pain