Randomized Controlled TrialNCT06591832
Effect of Virtual Reality-Based Relaxation Exercise on Postoperative Pain and Kinesiophobia After Total Knee Replacement
A study testing Exercise in people with Randomized Controlled Trial, run by Aksaray University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of virtual reality-based relaxation exercise on pain and kinesiophobia in patients after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Randomized Controlled Trial
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 31 Dec 2024
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The research included people between the ages of 40-75,
- Volunteering to participate in the research,
- Being able to understand and speak Turkish,
- Being able to understand the verbal, written and video explanations given,
- Having no problems communicating cognitively, affectively and verbally,
- Not having any obstacle to using virtual reality glasses,
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- Patients who underwent unilateral TKA surgery,
- Using the SPH device at the same degree for three postoperative days after the FFP operation.
- Having the surgeon's permission
Who cannot join
- Patients who will undergo revision TDP surgery,
- Those who have a neurological disease that causes functional disability,
- Those with a diagnosed psychiatric disorder,
- Refusing to take the SPH device after the operation or taking it to a different degree,
- Those who have a condition that prevents them from wearing virtual glasses for any reason,
- These are patients after the FFP operation and outside the third postoperative day.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aksaray University
Aksaray, 68100
Aksaray Universitesi
Aksaray
About this study
Official title: Effect of Virtual Reality-Based Relaxation Exercise on Postoperative Pain and Kinesiophobia After Total Knee Replacement: Randomized Controlled Study
The aim of this study is to evaluate the effect of virtual reality-based relaxation exercise on pain and kinesiophobia in patients after total knee arthroplasty.
Read the detailed description
Virtual reality application, which is a non-pharmacological application; It is a three-dimensional simulation model that gives individuals the feeling of reality and allows mutual communication with a dynamic environment created by computers, and studies determining the effects of the application are increasing day by day. Virtual reality-based rehabilitation is a promising approach to achieve recovery in many cases, optimize functional outcomes, and increase the clinical and social benefits of surgery . As a result, pain and fear of movement may negatively affect early functional results in patients undergoing total knee arthroplasty. Explaining how to change patients' fears, encouraging them to adopt positive attitudes and increasing their physical strength has an important place in determining the effectiveness of virtual reality application.
- Conditions
- Randomized Controlled Trial
- Being tested
- Exercise
- Keywords
- Pain, kinesiophobia, virtual reality glasses
- Medical subject headings
- Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Virtual reality based progressive relaxation exercise
| Study group | Role | What they receive |
|---|---|---|
| Experimental Gorup | Experimental | Routine nursing practice will be performed and Virtual reality based progressive relaxation exercise will be applied Receives: Other: Exercise |
| Control Group | No intervention | Routine nursing practice will be performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual Analog Scale
Measured: Min 0 Max 10 (As the score increases, the pain increases.)
Tampa kinesiophobia scale
assesses fear of movement
Measured: min 17 max 68 (As the score increases, the fear of movement increases.)
Secondary outcomes (2)
After application Visual Analog Scale
Visual Analog Scale
Measured: Min 0 Max 10 (As the score increases, the pain increases.)
After application Tampa kinesiophobia scale
assesses fear of movement
Measured: min 17 max 68 (As the score increases, the fear of movement increases.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Jan 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Randomized Controlled TrialStudies 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
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aksaray University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Kocak, Aksaray University
- Investigators
- Zeynep Koçak, Principal investigator, Aksaray UniversityFunda Çetinkaya, Principal investigator, Aksaray University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591832
- Sponsor's protocol ID
- 2023/23-30
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality-Based Relaxation Exercise on Postoperative Pain and Kinesiophobia After Total Knee Replacement: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06591832
- Acronym / sponsor ID
- 2023/23-30
- Conditions
- Randomized Controlled Trial
- Keywords
- Pain, kinesiophobia, virtual reality glasses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Aksaray UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (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 aim of this study is to evaluate the effect of virtual reality-based relaxation exercise on pain and kinesiophobia in patients after total knee arthroplasty.
Detailed description
Virtual reality application, which is a non-pharmacological application; It is a three-dimensional simulation model that gives individuals the feeling of reality and allows mutual communication with a dynamic environment created by computers, and studies determining the effects of the application are increasing day by day. Virtual reality-based rehabilitation is a promising approach to achieve recovery in many cases, optimize functional outcomes, and increase the clinical and social benefits of surgery . As a result, pain and fear of movement may negatively affect early functional results in patients undergoing total knee arthroplasty. Explaining how to change patients' fears, encouraging them to adopt positive attitudes and increasing their physical strength has an important place in determining the effectiveness of virtual reality application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Gorup | Experimental | Other: ExerciseRoutine nursing practice will be performed and Virtual reality based progressive relaxation exercise will be applied |
| Control Group | No intervention | –Routine nursing practice will be performed |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The research included people between the ages of 40-75,
- Volunteering to participate in the research,
- Being able to understand and speak Turkish,
- Being able to understand the verbal, written and video explanations given,
- Having no problems communicating cognitively, affectively and verbally,
Key exclusion criteria (6 listed)
- Patients who will undergo revision TDP surgery,
- Those who have a neurological disease that causes functional disability,
- Those with a diagnosed psychiatric disorder,
- Refusing to take the SPH device after the operation or taking it to a different degree,
- Those who have a condition that prevents them from wearing virtual glasses for any reason,
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 |
|---|---|---|
| ExerciseVirtual reality based progressive relaxation exercise | Other | Experimental Gorup |
Primary outcome
Visual Analog Scale
Time frame: Min 0 Max 10 (As the score increases, the pain increases.)
Visual Analog Scale
Tampa kinesiophobia scale
Time frame: min 17 max 68 (As the score increases, the fear of movement increases.)
assesses fear of movement
2 secondary outcomes
After application Visual Analog Scale
Time frame: Min 0 Max 10 (As the score increases, the pain increases.)
After application Tampa kinesiophobia scale
Time frame: min 17 max 68 (As the score increases, the fear of movement increases.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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.
Zeynep Koçak principal investigator
Aksaray University
Funda Çetinkaya principal investigator
Aksaray University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Randomized Controlled Trial, run by Aksaray University at 2 sites 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 9 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Min 0 Max 10 (As the score increases, the pain increases.)). The study lists 2 primary outcomes in all. 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 19 Sep 2024.