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

NCT06544512 | Completed

• 1 other identifier: AtaturkUNI00
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety; Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• VAS( Visual Analog Scale)

  It is a scale with two different names on the two ends on a 10 cm long vertical or horizontal line (0=no pain, 10=most severe pain). The patient is asked to mark the point on this line that corresponds to the intensity of pain he feels.

  on the day of the surgery

• State-Trait Anxiety Scale

  The State-Trait Anxiety Inventory, which was adapted to Turkish culture by Öner and Le Compte (1983), and in which validity and reliability studies were conducted as well as norm studies, consists of a total of 40 items, including a State Anxiety Scale consisting of 20 items and a Trait Anxiety Scale consisting of 20 items. According to the "Item Remainder" correlation technique, which provides detailed information about the reliability and validity of the items forming the scale; the item reliability correlations of the Turkish form are between 0.34 and 0.72 for the Trait Anxiety Scale and between 0.42 and 0.85 for the State Anxiety Scale.

  on the day of the surgery

Study Arms (2)

the group that performed relaxation exercises

EXPERIMENTAL

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

Other: progressive relaxation exercise

the group that did not do relaxation exercises

NO INTERVENTION

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

Interventions

progressive relaxation exercise OTHER

looking at pain and anxiety by practicing progressive relaxation exercises

the group that performed relaxation exercises

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Van Yüzüncü Yıl University Dursun Odabaş Medical Center

Van, 65000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: intervention and control

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: August 9, 2024
• Study Start: August 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

TU (1)