The Effect of Progressive Relaxation Exercises on Postoperative Pain

NCT ID: NCT05971641

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-09

Study Completion Date

2025-09-01

Brief Summary

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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

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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%.

Conditions

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Arthroplasty Replacement Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two group with a progressive relaxation exercise intervention group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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

Study Groups

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intervention group

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

Group Type ACTIVE_COMPARATOR

progressive relaxation exercise

Intervention Type 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.

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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progressive relaxation exercise

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 Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bartın Unıversity

OTHER

Sponsor Role lead

Responsible Party

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Rumeysa Birkanım

Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rumeysa Birkanım, Msc student

Role: PRINCIPAL_INVESTIGATOR

Bartın Unıversity

Central Contacts

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Rumeysa Birkanım, Msc student

Role: CONTACT

+905458107793

Sevim Çelik, Professor

Role: CONTACT

+905327832989

Other Identifiers

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Bartın U

Identifier Type: -

Identifier Source: org_study_id

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