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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05591898
Study type Interventional
Source Basaksehir Cam & Sakura Sehir Hospital
Contact
Status Enrolling by invitation
Phase N/A
Start date January 15, 2023
Completion date December 15, 2023

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