Effect of PMR on Anxiety and Pain Level in Patients Undergoing Obesity Surgery

NCT ID: NCT06544512

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-03-30

Brief Summary

The aim of this clinical trial is to find out whether progressive relaxation exercises work on the effect of anxiety and pain level in patients undergoing obesity surgery. The main questions that it aims to answer are:

• Do progressive relaxation exercises reduce participants' pain levels?
• Do progressive relaxation exercises reduce participants' anxiety levels? The researchers will compare the effect of progressive relaxation exercises on the level of anxiety and pain between experimental and control groups .

Participants:

• He will experience obesity surgery surgery as planned for the first time

• Who volunteered to participate in the research
• 18 years and over
• The mental state is healthy

Detailed Description

Obesity, which has been increasing in frequency in recent years, is a public health problem that many factors such as age, gender, education level, marital status and lack of physical activity are responsible for. The treatment of obesity can be divided into several stages: diet, physical activity, medical treatment and surgical treatment. Obesity surgery is resorted to in cases where diet therapy or medical treatment accompanied by physical activity does not give results. The sick individual is concerned both as a result of the physical effects of the disease on himself or as a result of the environmental change brought about by hospitalization. Encountering procedures that cause physical pain, being away from family, losing one's job, encountering unknown tools and procedures are some of the factors that may cause the hospitalized individual to feel anxiety. Having surgery is also among these factors and occupies an important place. Surgery includes the meanings of pain for the patient, loss of independence, deterioration in body image, and each of these elements is perceived as a threat. Nonpharmacological treatment to reduce postoperative pain and anxiety; the patient can be relieved by using methods such as diverting attention, listening to music, relaxation, breathing techniques, meditation, hypnosis. Progressive relaxation exercises are one of these methods. Progressive relaxation exercises involve the voluntary stretching and Novation of all muscle groups in the human body. Progressive relaxation exercise is a type of exercise that relaxes a person physically and spiritually, reduces a person's blood pressure, pain sensitivity, fatigue, stress, anxiety, heart rate, and positively affects a person physically and spiritually.The aim of this clinical trial is to find out whether progressive relaxation exercises work on the effect of anxiety and pain level in patients undergoing obesity surgery. The main questions that it aims to answer are:

• Do progressive relaxation exercises reduce participants' pain levels?
• Do progressive relaxation exercises reduce participants' anxiety levels? This research is planned to be conducted at the General Surgery Clinic of Van Yüzüncü Yıl University Dursun Odabaş Medical Center between August 2023- March 2024. The research is planned to be conducted in the General Surgery Clinic of Van Yüzüncü Yil University. Dependent Variables: State-Trait Anxiety scale, VAS Pain Scale Independent Variables: Training in progressive relaxation exercises Control Variables: the patient's age, gender, marital status, educational level, the status of having had surgery before, the status of having another health problem.

Collection of Data and Initiatives:Firstly, approval from the Ethics Committee of Atatürk University Faculty of Medicine and written permissions from the hospitals where the research will be conducted were obtained for the research. The "Patient Introduction Form", the "Condition-Continuity Anxiety Scale", the "Visual Analog Scale (VAS) Pain Form" will be used in the collection of research data. The data collection tools will be applied as follows: Questionnaires will be filled out by the researcher to the patients using the face-to-face interview technique.The scales will be introduced and the Patient Introduction form, the Status-Trait Anxiety Scale and the Visual Analog Scale (VAS) Pain Form will be completed. Later relaxation exercises will be performed during a session lasting 30 minutes, and after the session, the State-Trait Anxiety Scale and the Visual Analog Scale (VAS) Pain Form will be re-applied to patients.

Conditions

Anxiety; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

the group that performed relaxation exercises

The group that received progressive relaxation exercise and filled out the pain and state-trait anxiety scales

Group Type: EXPERIMENTAL

progressive relaxation exercise

Intervention Type: OTHER

looking at pain and anxiety by practicing progressive relaxation exercises

the group that did not do relaxation exercises

The group that did not receive progressive relaxation exercise and only filled out the pain and state-trait anxiety scales

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

progressive relaxation exercise

looking at pain and anxiety by practicing progressive relaxation exercises

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• He will experience obesity surgery surgery as planned for the first time
• Who volunteered to participate in the research 18 years and over
• The mental state is healthy
• Without vision, hearing and speech problems
• Patients who know Turkish will be included in the study.

Exclusion Criteria

• The patient has had bariatric surgery before,
• Have previously applied progressive relaxation exercises,
• Having a communication problem,
• Progressive relaxation exercise prevents the practice of health problems (epilepsy, bipolar disorder, schizophrenia, fever, infection, etc.) to be
• It has been determined that the patient does not want to be involved in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Şuheda Zorer

research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Van Yüzüncü Yıl University Dursun Odabaş Medical Center

Van, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AtaturkUNI00

Identifier Type: -

Identifier Source: org_study_id