The Effect of Progressive Relaxation Exercises on Postoperative Pain

NCT05971641 | Not Yet Recruiting

• 1 other identifier: Bartın U
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

The indicators of patient recovery in the postoperative period include sleep, physical functionality, mental health, cognitive functionality, pain, and psychosocial functionality. This thesis aims to investigate the effects of progressive relaxation exercises on postoperative pain intensity, sleep quality, and recovery in patients undergoing total knee arthroplasty.This study, designed as a randomized controlled experimental study, will be conducted between September 1, 2023, and August 1, 2024, at ÇAYCUMA State Hospital in ZONGULDAK province, Turkey, among patients undergoing total knee arthroplasty. A total of 96 patients will be recruited based on the sample size calculated using G-power analysis. Through block randomization, 48 patients will be assigned to the intervention group and 48 patients to the control group. Data will be collected using the Numeric Rating Scale for pain, the Richard-Campbell Sleep Scale, a sleep tracker smart wristband to measure sleep quality and duration, the Postoperative Recovery Index, and a Patient Information Form.

Conditions

Arthroplasty; Replacement; Knee

Keywords

Total Knee Replacement; Progressive relaxation exercises

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS):

  The numeric rating scale is used to objectively measure pain and evaluate the effectiveness of pain management. It is utilized to determine patients' pain levels and guide treatment plans. In this scale, participants express their pain level with a specific numerical value. Typically, pain intensity is rated on a scale of 0 to 10, where 0 represents no pain and 10 represents the most severe pain. Participants are asked to indicate their pain intensity using a number based on their own experiences and perceptions. For example, a value between 0 and 2 may indicate mild pain, a value between 3 and 5 may indicate moderate pain, a value between 6 and 8 may indicate severe pain, and a value between 9 and 10 may indicate the most intense pain.

  six day

Secondary Outcomes (2)

• Richard Campbell Sleep Questionnaire (RCSQ):

  five day

• Postoperative Recovery Index Scale (PRIS):

  four day

Study Arms (2)

intervention group

ACTIVE COMPARATOR

The experimental group is the one in which progressive relaxation exercises will be taught, and we will monitor the results in patients.

Other: progressive relaxation exercise

control group

NO INTERVENTION

The control group is the one in which the service routine is implemented, and progressive relaxation exercises are not taught but monitored.

Interventions

progressive relaxation exercise OTHER

Patients who undergo total knee replacement surgery in the experimental group will be taught progressive relaxation exercises. The exercise will last for 30 minutes and will be applied twice a day. Patients will wear a smart wristband. Patient Information Form, Numeric Rating Scale, Richard Campbell Sleep Quality Survey, and Postoperative Recovery Index Scale will be administered. The scales will be filled out for 5 days and will take approximately 10-15 minutes.

intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older,
• Without diagnosed mental disorders,
• Without visual, hearing, and speech impairments,
• Proficient in Turkish,
• Diagnosed with gonarthrosis and scheduled for total knee replacement,
• No postoperative complications following total knee replacement surgery,
• Literate with an educational level,
• Pain level of 4 or above on the NRS,
• Receiving analgesic treatment according to the clinical protocol,
• Ownership of a mobile device such as a smart phone or tablet capable of accessing internet-based video content with the latest technology from any brand,
• Patients without diagnosed sleep problems will be included in the thesis study.

You may not qualify if:

• Illiterate individuals,
• Under the age of 18,
• Having a condition that hinders communication,
• Referred from another center after surgery,
• Pain level of 4 or below on the NRS,
• Developing complications after total knee replacement surgery,
• Receiving analgesic treatment and methods outside of the clinical protocol,
• Not owning a mobile device such as a smart phone or tablet capable of accessing internet-based video content with the latest technology from any brand,
• Having diagnosed sleep problems,
• Having diagnosed mental disorders, will be excluded from the scope of the thesis study.

Sponsors & Collaborators

• Bartın Unıversity: lead

Study Officials

• Rumeysa Birkanım, Msc student

  Bartın Unıversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rumeysa Birkanım, Msc student

CONTACT

+905458107793; rumeysa.birkanim67@gmail.com

Sevim Çelik, Professor

CONTACT

+905327832989; sevimakcel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A total of 96 patients will be recruited based on the sample size calculated using G-power analysis. Through block randomization, 48 patients will be assigned to the intervention group and 48 patients to the control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: Two group with a progressive relaxation exercise intervention group

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: December 9, 2024
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share