ArthroplastyNCT05971641
The Effect of Progressive Relaxation Exercises on Postoperative Pain
A study testing progressive relaxation exercise in people with Arthroplasty and Replacement, run by Bartın Unıversity.
Trial summary
The indicators of patient recovery in the postoperative period include sleep, physical functionality, mental health, cognitive functionality, pain, and psychosocial functionality. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- progressive relaxation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Progressive Relaxation Exercises on Postoperative Pain Intensity, Sleep Quality, and Recovery in Patients Undergoing Total Knee Arthroplasty
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.
Read the 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%.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- progressive relaxation exercise
- Keywords
- Total Knee Replacement, Progressive relaxation exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six day
Secondary outcomes (2)
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.
Measured: five day
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.
Measured: four day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start9 Dec 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group with a progressive relaxation exercise intervention group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rumeysa Birkanım, Bartın Unıversity
- Investigators
- Rumeysa Birkanım, Msc student, Principal investigator, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971641
- Sponsor's protocol ID
- Bartın U
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises on Postoperative Pain Intensity, Sleep Quality, and Recovery in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05971641
- Acronym / sponsor ID
- Bartın U
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Total Knee Replacement, Progressive relaxation exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 9 Dec 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two group with a progressive relaxation exercise intervention group
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Other: progressive relaxation exerciseThe experimental group is the one in which progressive relaxation exercises will be taught, and we will monitor the results in patients. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| progressive relaxation exercisePatients 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. | Other | intervention group |
Primary outcome
Numeric Rating Scale (NRS):
Time frame: six day
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.
2 secondary outcomes
Richard Campbell Sleep Questionnaire (RCSQ):
Time frame: five day
Postoperative Recovery Index Scale (PRIS):
Time frame: four day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rumeysa Birkanım, Msc student principal investigator
Bartın Unıversity
Questions about this trial
What is this clinical trial studying?
A study testing progressive relaxation exercise in people with Arthroplasty and Replacement, run by Bartın Unıversity.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rumeysa Birkanım, Msc student (+905458107793, rumeysa.birkanim67@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS): (time frame: six day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.