The Effect of Progressive Relaxation Exercises on Bariatric Surgery Period

NCT05591898 | Unknown

• 1 other identifier: KAEK/2022.01.7
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid; Bariatric Surgery Candidate; Anxiety; Postoperative Pain

Keywords

bariatric surgery; Progressive relaxation exercises; anxiety; postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative pain level

  Postoperative pain scores collection is planned at the postoperative period in the first 48 hour after the surgery.

Study Arms (2)

Progressive relaxation exercises group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Progressive relaxation exercises BEHAVIORAL

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.

Progressive relaxation exercises group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having bariatric surgery plan (such as sleeve gastrectomy, gastric bypass),
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead
• Atlas University: collaborator
• Istanbul Medeniyet University: collaborator

Study Sites (1)

Başakşehir Çam & Sakura Şehir Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• Daniel S, Sindhu JV. Effectiveness of Progressive Muscle Relaxation Technique on Post Operative Pain and Anxiety Among patients Who Have Undergone Abdominal Surgery. International Journal of Nursing Critical Care. 2020; 6(1), 35-41.

  BACKGROUND

• David LA, Sijercic I, Cassin SE. Preoperative and post-operative psychosocial interventions for bariatric surgery patients: A systematic review. Obes Rev. 2020 Apr;21(4):e12926. doi: 10.1111/obr.12926. Epub 2020 Jan 22.

  PMID: 31970925 BACKGROUND

• Felix MMDS, Ferreira MBG, Oliveira LF, Barichello E, Pires PDS, Barbosa MH. Guided imagery relaxation therapy on preoperative anxiety: a randomized clinical trial. Rev Lat Am Enfermagem. 2018 Nov 29;26:e3101. doi: 10.1590/1518-8345.2850.3101.

  PMID: 30517586 BACKGROUND

• Gravani S, Matiatou M, Nikolaidis PT, Menenakos E, Zografos CG, Zografos G, Albanopoulos K. Anxiety and Depression Affect Early Postoperative Pain Dimensions after Bariatric Surgery. J Clin Med. 2020 Dec 25;10(1):53. doi: 10.3390/jcm10010053.

  PMID: 33375765 BACKGROUND

• Alvarez-Garcia C, Yaban ZS. The effects of preoperative guided imagery interventions on preoperative anxiety and postoperative pain: A meta-analysis. Complement Ther Clin Pract. 2020 Feb;38:101077. doi: 10.1016/j.ctcp.2019.101077. Epub 2019 Dec 4.

  PMID: 32056813 RESULT

MeSH Terms

Conditions

Obesity, Morbid; Anxiety Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Study Officials

• İsmail Çalıkoğlu, M.D.

  Başakşehir Çam & Sakura Şehir Hospital

  PRINCIPAL INVESTIGATOR

• İsmail Çalıkoğlu

  Başakşehir Çam & Sakura Şehir Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 24, 2022
• Study Start: January 15, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 15, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)