Clinical trial NCT05971641: The Effect of Progressive Relaxation Exercises on Postoperative Pain
Official title: The Effect of Progressive Relaxation Exercises on Postoperative Pain Intensity, Sleep Quality, and Recovery in Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthroplasty
Replacement
Knee
Keywords: Total Knee Replacement
Progressive relaxation exercises
Lead sponsor: Bartın Unıversity
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group with a progressive relaxation exercise intervention group
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Introduction: Knee osteoarthritis is observed in approximately 6% of adult individuals. Knee osteoarthritis, which causes pain in individuals, often results in the impairment of their daily lives. Total knee arthroplasty surgery is considered as the final method in the treatment process of knee osteoarthritis. The indicators of patient recovery in the postoperative period include sleep, physical functionality, mental health, cognitive functionality, pain, and psychosocial functionality.

Objective: 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.

Method: 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. The progressive relaxation exercises Compact disc 8 (CD) prepared by the Turkish Psychologists Association will be used for the patients' progressive relaxation exercise training. The data will be analyzed using the Statistical Package for the Social Sciences (SPSS) program. The data will be presented as numbers and percentages, means and standard deviations, and their distribution will be assessed to determine whether parametric or non-parametric tests should be employed for analysis. The data will be evaluated with a significance level of p\<0.05 and a confidence interval of 95%.

Eligibility criteria: Inclusion Criteria:

* 18 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Numeric Rating Scale (NRS):
timeFrame: six day
Secondary outcomes:
measure: Richard Campbell Sleep Questionnaire (RCSQ):
timeFrame: five day
measure: Postoperative Recovery Index Scale (PRIS):
timeFrame: four day
Other outcomes:
Locations:
Study officials:
affiliation: Bartın Unıversity
name: Rumeysa Birkanım, Msc student
role: PRINCIPAL_INVESTIGATOR
References: