Osteoarthritis (OA) of the HipNCT07354542
Effects of Different Relaxation Therapies on Pain and Sleep in Hip and Knee Arthroplasty Patients
A study testing Virtual Reality-Based Relaxation and Traditional Relaxation Therapy in people with Osteoarthritis (OA) of the Hip and Osteoarthritis (OA) of the Knee, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Knee
- What is being tested?
- Virtual Reality-Based Relaxation and Traditional Relaxation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 ,
Show all 11Show fewer
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bartın State Hospital
Bartın, Center, 74100
Mesut Çimen, Supervizor, +90 543 776 00 67, bartindh@saglik.gov.tr
About this study
Official title: 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.
Read more
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.
- Being tested
- Virtual Reality-Based Relaxation, Traditional Relaxation Therapy
- Keywords
- Postoperative Pain, Sleep Quality, Virtual Reality
- Medical subject headings
- Osteoarthritis, Pain, Postoperative, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based RelaxationBehavioural
Relaxation exercises delivered through virtual reality technology during the postoperative period following hip and knee replacement surgery.
Traditional Relaxation TherapyBehavioural
Standard relaxation exercises performed without virtual reality during the postoperative period following hip and knee replacement surgery.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-Based Relaxation Group | Experimental | 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. Receives: Behavioral: Virtual Reality-Based Relaxation |
| Traditional Relaxation Therapy Group | Active comparator | 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. Receives: Behavioral: Traditional Relaxation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
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.
Measured: Postoperative three days period
Secondary outcomes (1)
Sleep Quality
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.
Measured: Postoperative three days period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Nov 2024
- Primary completion15 Jan 2026
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the HipStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Soydan, Bartın Unıversity
- Investigators
- Sevim Çelik, Professor, Study director, Bartin University Health Science Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354542
- Sponsor's protocol ID
- BartınU-SBF-MS-01
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 23 Jan 2026
- 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 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07354542
- Acronym / sponsor ID
- BartınU-SBF-MS-01
- Keywords
- Postoperative Pain, Sleep Quality, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 21 Jan 2026 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-Based Relaxation Group | Experimental | Behavioral: Virtual Reality-Based RelaxationParticipants 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. |
| Traditional Relaxation Therapy Group | Active comparator | Behavioral: Traditional Relaxation TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
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 |
|---|---|---|
| Virtual Reality-Based RelaxationRelaxation exercises delivered through virtual reality technology during the postoperative period following hip and knee replacement surgery. | Behavioural | Virtual Reality-Based Relaxation Group |
| Traditional Relaxation TherapyStandard relaxation exercises performed without virtual reality during the postoperative period following hip and knee replacement surgery. | Behavioural | Traditional Relaxation Therapy Group |
Primary outcome
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.
1 secondary outcome
Sleep Quality
Time frame: Postoperative three days period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- 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.
Sevim Çelik, Professor study director
Bartin University Health Science Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Based Relaxation and Traditional Relaxation Therapy in people with Osteoarthritis (OA) of the Hip and Osteoarthritis (OA) of the Knee, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
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 6 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meltem Soydan, Nurse (+90 545 890 12 99, meltemsoydannn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: Postoperative three days period). 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 23 Jan 2026.