- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07354542
Effects of Different Relaxation Therapies on Pain and Sleep in Hip and Knee Arthroplasty Patients
Comparison of the Effects of Virtual Reality-based and Traditional Relaxation Therapy on Postoperative Pain and Sleep Quality in Patients Undergoing Hip and Knee Replacement Surgery
Hip and knee replacement surgery is commonly performed in older adults. After surgery, many patients experience pain, limited movement, and sleep problems. These difficulties can make daily activities such as walking or climbing stairs more challenging and may reduce quality of life during recovery.
Relaxation exercises are often used to help reduce pain and improve sleep after surgery. Virtual reality (VR) is a technology that provides a multisensory experience and may help people relax by shifting their attention away from pain and discomfort.
This study is designed to compare two different relaxation approaches used after hip and knee replacement surgery. One group of patients will perform relaxation exercises using virtual reality, while another group will perform traditional relaxation exercises. The study will examine pain levels and sleep quality in both groups.
The results of this study may help to better understand whether virtual reality-based relaxation can be used as an alternative or supportive method for managing pain and sleep problems after joint replacement surgery.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Meltem Soydan, Nurse
- Phone Number: +90 545 890 12 99
- Email: meltemsoydannn@gmail.com
Study Locations
-
-
Center
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Bartın, Center, Turkey (Türkiye), 74100
- Recruiting
- Bartın State Hospital
-
Contact:
- Mesut Çimen, Supervizor
- Phone Number: +90 543 776 00 67
- Email: bartindh@saglik.gov.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Those who volunteered to participate in the research,
- 18 years and older,
- No diagnosed mental or sleep problems, epilepsy, or depression,
- No vision, hearing, or speech problems,
- Those who speak Turkish,
- Knee and hip replacement surgery ,
- No active nausea or vomiting prior to the virtual reality application,
- According to the Numerical Rating Scale, the patient reports pain.
- Those receiving analgesia treatment according to clinical protocol,
- Anyone who owns a mobile phone or tablet capable of playing videos, using any brand of internet provider,
- Patients who had not previously practiced breathing exercises were included .
Exclusion Criteria:
- Having a problem that prevents communication,
Being admitted to the ward where the surgery and study were performed at another center,
. Complications develop after knee and hip replacement surgery,
- Nausea and vomiting may occur during the procedure.
- Wanting to withdraw from the research,
- Experiencing chronic pain.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality-Based Relaxation Group
Participants receive relaxation exercises delivered through virtual reality technology following hip and knee replacement surgery.
The intervention is provided during the postoperative period in addition to standard care.
|
Relaxation exercises delivered through virtual reality technology during the postoperative period following hip and knee replacement surgery.
|
|
Active Comparator: Traditional Relaxation Therapy Group
Participants receive traditional relaxation exercises without virtual reality following hip and knee replacement surgery.
The intervention is provided during the postoperative period in addition to standard care.
|
Standard relaxation exercises performed without virtual reality during the postoperative period following hip and knee replacement surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity
Time Frame: Postoperative three days period
|
Pain intensity will be assessed using Numerical Rating Scale (0-10 points) in patients undergoing hip and knee replacement surgery.
0 represents no pain and 10 represents the most severe pain.
|
Postoperative three days period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Quality
Time Frame: Postoperative three days period
|
Sleep quality will be evaluated using Richards Campbell Sleep Questionnaire (0-100 points) during the postoperative period.The scale uses a score range of "0-25" to indicate very poor sleep and a score range of "76-100" to indicate very good sleep.
The total score is evaluated based on 5 items; item 6, which assesses the noise level in the environment, is excluded from the total score evaluation.
As the score obtained from the questionnaire increases, it is interpreted that the patients' sleep quality has improved.
|
Postoperative three days period
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sevim Çelik, Professor, Bartin University Health Science Faculty
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Osteoarthritis
- Sleep Initiation and Maintenance Disorders
Other Study ID Numbers
- BartınU-SBF-MS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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