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The Effect of Progressive Relaxation Exercises on Postoperative Pain

Primary Purpose

Arthroplasty, Replacement, Knee

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
progressive relaxation exercise
Sponsored by
Bartın Unıversity
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthroplasty focused on measuring Total Knee Replacement, Progressive relaxation exercises

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    intervention group

    control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Richard Campbell Sleep Questionnaire (RCSQ):
    The Richard Campbell Sleep Questionnaire (RCSQ), developed by Richards (1987), is a 6-item scale that assesses the depth of nighttime sleep, sleep onset latency, frequency of awakenings, duration of wakefulness upon awakening, sleep quality, and noise levels in the environment. Each item is evaluated on a visual analog scale ranging from 0 to 100. Scores between '0-25' indicate very poor sleep, while scores between '76-100' indicate very good sleep. The scale's total score is based on the evaluation of 5 items, excluding the 6th item that assesses the noise level in the environment. As the score increases on the scale, the quality of patients' sleep also improves.
    Postoperative Recovery Index Scale (PRIS):
    The Postoperative Recovery Index Scale (PRIS), developed by Butler et al. in 2012, is a scale that can be used within 30 days after surgery. It is suitable for different surgical procedures. PRIS consists of 5 subscales, which are psychological symptoms, physical activities, general symptoms, bowel symptoms, and desire-satisfaction symptoms. The scores of the items within each subscale are summed, arithmetic means are calculated, and subscale scores are determined. For the total score of PRIS, all 25 items are summed, and the arithmetic mean is taken. Higher scores obtained from the index reflect greater difficulties in postoperative recovery, while lower scores indicate easier postoperative recovery.

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    August 14, 2023
    Sponsor
    Bartın Unıversity
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05971641
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bartın Unıversity

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthroplasty, Replacement, Knee
    Keywords
    Total Knee Replacement, Progressive relaxation exercises

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two group with a progressive relaxation exercise intervention group
    Masking
    Participant
    Masking Description
    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
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Active Comparator
    Arm Description
    The experimental group is the one in which progressive relaxation exercises will be taught, and we will monitor the results in patients.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    The control group is the one in which the service routine is implemented, and progressive relaxation exercises are not taught but monitored.
    Intervention Type
    Other
    Intervention Name(s)
    progressive relaxation exercise
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Numeric Rating Scale (NRS):
    Description
    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.
    Time Frame
    six day
    Secondary Outcome Measure Information:
    Title
    Richard Campbell Sleep Questionnaire (RCSQ):
    Description
    The Richard Campbell Sleep Questionnaire (RCSQ), developed by Richards (1987), is a 6-item scale that assesses the depth of nighttime sleep, sleep onset latency, frequency of awakenings, duration of wakefulness upon awakening, sleep quality, and noise levels in the environment. Each item is evaluated on a visual analog scale ranging from 0 to 100. Scores between '0-25' indicate very poor sleep, while scores between '76-100' indicate very good sleep. The scale's total score is based on the evaluation of 5 items, excluding the 6th item that assesses the noise level in the environment. As the score increases on the scale, the quality of patients' sleep also improves.
    Time Frame
    five day
    Title
    Postoperative Recovery Index Scale (PRIS):
    Description
    The Postoperative Recovery Index Scale (PRIS), developed by Butler et al. in 2012, is a scale that can be used within 30 days after surgery. It is suitable for different surgical procedures. PRIS consists of 5 subscales, which are psychological symptoms, physical activities, general symptoms, bowel symptoms, and desire-satisfaction symptoms. The scores of the items within each subscale are summed, arithmetic means are calculated, and subscale scores are determined. For the total score of PRIS, all 25 items are summed, and the arithmetic mean is taken. Higher scores obtained from the index reflect greater difficulties in postoperative recovery, while lower scores indicate easier postoperative recovery.
    Time Frame
    four day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rumeysa Birkanım, Msc student
    Phone
    +905458107793
    Email
    rumeysa.birkanim67@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sevim Çelik, Professor
    Phone
    +905327832989
    Email
    sevimakcel@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rumeysa Birkanım, Msc student
    Organizational Affiliation
    Bartın Unıversity
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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