Virtual RealityTHANCT07689461
VR Effects After Hip Replacement Surgery Pain
A study testing cognitive intervention in people with Virtual Reality and Hip Arthropathy, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
Total Hip Arthroplasty (THA), a procedure performed to enhance the quality of life, is accompanied by postoperative challenges such as pain and anxiety that adversely affect patient comfort. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Virtual Reality, Hip Arthropathy, Comfort
- What is being tested?
- cognitive intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2025to 31 Dec 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective surgery who agree to participate in the study,
- Individuals 18 years of age or older,
- Those with adequate cognitive function,
- Those who have not previously undergone total hip replacement surgery,
- Those who volunteer to participate in the study and sign the informed consent form,
- Patients with a pain score (on a scale of 1 to 10) of 4 or higher were included in the study.
Who cannot join
- Individuals under the age of 18,
- Those previously diagnosed with a chronic pain syndrome (other than hip osteoarthritis),
- Individuals with impaired cognitive function (severe psychiatric disorders),
- Individuals who have previously undergone total hip replacement surgery,
- Individuals with severe hearing or visual impairments,
- Individuals with a history of opioid dependence,
- Patients with a pain score (on a scale of 1 to 10) of 4 or lower were excluded from the study.
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
Malatya Turgut Özal University
Malatya, 44900
Malatya Turgut Özal Medical Center, 4228461255 ext. +90, ilker.ayten@ozal.edu.tr
About this study
Official title: The Effect of Virtual Reality on Pain, Anxiety, and Comfort Levels After Total Hip Replacement Surgery
Total Hip Arthroplasty (THA), a procedure performed to enhance the quality of life, is accompanied by postoperative challenges such as pain and anxiety that adversely affect patient comfort. Inadequate management of these complications can prolong the length of hospital stay, delay recovery, lead to functional impairments, and elevate the risk of chronic pain development. Conventional pharmacological interventions employed for management are limited due to their potential for adverse effects and dependency. Virtual reality (VR) is a non-pharmacological distraction technique utilized in the healthcare sector, leveraging advanced technology to maximize patient comfort by alleviating pain and minimizing anxiety.
A review of the literature reveals that while the use of VR has positive effects on pain and anxiety, there is a notable scarcity of high-quality randomized controlled trials concurrently evaluating its impact on pain, anxiety, and comfort levels in postoperative orthopedic procedures such as THA. In this randomized controlled trial, participants in the control group will receive standard care, whereas those in the experimental group will receive a 30-minute VR intervention-offering three distinct options-in addition to standard care during the acute phase of the first 48 hours. Postoperative assessments will be conducted using the Visual Analogue Scale (VAS) for pain intensity, the State Anxiety Inventory for anxiety levels, and the Perianesthesia Comfort Scale for comfort levels.
By evaluating the potential of VR as a non-pharmacological adjuvant in post-THA care, the findings of this study will provide significant contributions to evidence-based nursing practices aimed at developing multimodal pain management strategies, reducing opioid consumption, and enhancing patient satisfaction.
- Conditions
- Virtual Reality, Hip Arthropathy, Comfort, Anxiety, Pain, Postoperative
- Being tested
- cognitive intervention
- Keywords
- Virtual Reality, Total Hip Arthroplasty, Postoperative Pain, Anxiety, Comfort Level
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive interventionBehavioural
The patient undergoing the virtual reality session will lie in a supine position, supported and comfortable, with the head elevated at an angle of 30˚-45˚. The content will feature nature sounds and soothing background music; three different segments will be programmed: a forest or beach landscape, an underwater scene, and an outdoor excursion. Each option consists of 30 minutes of footage. The patient will select their preferred footage from these options, and after the sound settings are adjusted to a level the patient finds comfortable and non-disturbing, the session will begin and last for 30 minutes. Following the session, data will be collected in a face-to-face setting.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in the experimental group will undergo a virtual reality headset intervention. This intervention will be administered to patients in the clinic during the acute phase-the first 48 hours following total hip replacement surgery. The scales used in the study will be administered twice: once before and once after the intervention. Receives: Behavioral: cognitive intervention |
| Control Group | No intervention | Participants in the control group will receive standard care. The intervention will be administered to patients who are in the clinic during the acute phase-the first 48 hours-following total hip replacement surgery. The scales used in the study will be administered twice: once before and once after the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Pain in Patients After Total Hip Arthroplasty Surgery
The Visual Analog Scale (VAS) was used to measure pain intensity; it is a simple, unidimensional measure. It was developed by Price et al. in 1983 to assess perceived pain. Compared to the VAS scale, which is known to be more sensitive in the assessment and characterization of acute pain, "no pain" is rated as 0 points and "most severe pain" as 10 points. On this scale, an increase in score indicates an increase in pain. Pain is also categorized as mild (<3), moderate (3-6), and severe (>6).
Measured: The first 24 hours after surgery, 25-48 hours after surgery
Evaluation of Anxiety in Patients After Total Hip Arthroplasty Surgery
The Spielberger State-Trait Anxiety Inventory was used to assess patients' anxiety levels. The original scale was developed in 1970 by Spielberger and his team and adapted to the Turkish language and culture by Öner and Le Compte. Scale items are answered on a four-point Likert-type scale. For the state anxiety scale, the response options are "not at all," "a little," "a lot," and "completely," while for the trait anxiety scale, they are "never," "sometimes," "most of the time," and "almost always." Higher scores on the scale indicate higher levels of anxiety, while lower scores indicate lower levels of anxiety. According to the score ranges established by Spielberger and colleagues, a score of 0-19 indicates no anxiety, 20-39 indicates mild anxiety, 40-59 indicates moderate anxiety, and 60-79 indicates severe anxiety.
Measured: The first 24 hours after surgery, 25-48 hours after surgery
Evaluation of Comfort Levels in Patients After Total Hip Arthroplasty Surgery
The comfort levels of postoperative patients were assessed using the Perianesthesia Comfort Scale. The scale was developed by Kolcaba in 1990 and adapted into Turkish by Üstündağ and Aslan (2010). The Perianesthesia Comfort Scale (PCS) is a self-report assessment tool designed to measure individuals' comfort levels during the perianesthesia period. The scale consists of a total of 24 items and uses a six-point Likert-type scale. Participants respond to each item with scores ranging from "strongly disagree (1)" to "strongly agree (6)." The total score that can be obtained from the scale ranges from 24 to 144. The total score is divided by the number of items to calculate the mean score, which is expressed as a value between 1 and 6. A low mean score indicates a low level of comfort, while a high mean score indicates a high level of comfort.
Measured: The first 24 hours after surgery, 25-48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start21 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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 Research
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oğuzhan Çağlar, Adiyaman University
- Investigators
- OĞUZHAN ÇAĞLAR, MSc Std, Principal investigator, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689461
- Sponsor's protocol ID
- VR-THA-2026
- Acronym
- THA
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Pain, Anxiety, and Comfort Levels After Total Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT07689461
- Acronym / sponsor ID
- THA / VR-THA-2026
- Conditions
- Virtual Reality, Hip Arthropathy, Comfort, Anxiety, Pain, Postoperative
- Keywords
- Virtual Reality, Total Hip Arthroplasty, Postoperative Pain, Anxiety, Comfort Level
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jul 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.
Total Hip Arthroplasty (THA), a procedure performed to enhance the quality of life, is accompanied by postoperative challenges such as pain and anxiety that adversely affect patient comfort. Inadequate management of these complications can prolong the length of hospital stay, delay recovery, lead to functional impairments, and elevate the risk of chronic pain development. Conventional pharmacological interventions employed for management are limited due to their potential for adverse effects and dependency. Virtual reality (VR) is a non-pharmacological distraction technique utilized in the healthcare sector, leveraging advanced technology to maximize patient comfort by alleviating pain and minimizing anxiety.
A review of the literature reveals that while the use of VR has positive effects on pain and anxiety, there is a notable scarcity of high-quality randomized controlled trials concurrently evaluating its impact on pain, anxiety, and comfort levels in postoperative orthopedic procedures such as THA. In this randomized controlled trial, participants in the control group will receive standard care, whereas those in the experimental group will receive a 30-minute VR intervention-offering three distinct options-in addition to standard care during the acute phase of the first 48 hours. Postoperative assessments will be conducted using the Visual Analogue Scale (VAS) for pain intensity, the State Anxiety Inventory for anxiety levels, and the Perianesthesia Comfort Scale for comfort levels.
By evaluating the potential of VR as a non-pharmacological adjuvant in post-THA care, the findings of this study will provide significant contributions to evidence-based nursing practices aimed at developing multimodal pain management strategies, reducing opioid consumption, and enhancing patient satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Research
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: cognitive interventionParticipants in the experimental group will undergo a virtual reality headset intervention. This intervention will be administered to patients in the clinic during the acute phase-the first 48 hours following total hip replacement surgery. The scales used in the study will be administered twice: once before and once after the intervention. |
| Control Group | No intervention | –Participants in the control group will receive standard care. The intervention will be administered to patients who are in the clinic during the acute phase-the first 48 hours-following total hip replacement surgery. The scales used in the study will be administered twice: once before and once after the intervention. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled for elective surgery who agree to participate in the study,
- Individuals 18 years of age or older,
- Those with adequate cognitive function,
- Those who have not previously undergone total hip replacement surgery,
- Those who volunteer to participate in the study and sign the informed consent form,
Key exclusion criteria (7 listed)
- Individuals under the age of 18,
- Those previously diagnosed with a chronic pain syndrome (other than hip osteoarthritis),
- Individuals with impaired cognitive function (severe psychiatric disorders),
- Individuals who have previously undergone total hip replacement surgery,
- Individuals with severe hearing or visual impairments,
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 |
|---|---|---|
| cognitive interventionThe patient undergoing the virtual reality session will lie in a supine position, supported and comfortable, with the head elevated at an angle of 30˚-45˚. The content will feature nature sounds and soothing background music; three different segments will be programmed: a forest or beach landscape, an underwater scene, and an outdoor excursion. Each option consists of 30 minutes of footage. The patient will select their preferred footage from these options, and after the sound settings are adjusted to a level the patient finds comfortable and non-disturbing, the session will begin and last for 30 minutes. Following the session, data will be collected in a face-to-face setting. | Behavioural | Experimental Group |
Primary outcome
Evaluation of Pain in Patients After Total Hip Arthroplasty Surgery
Time frame: The first 24 hours after surgery, 25-48 hours after surgery
The Visual Analog Scale (VAS) was used to measure pain intensity; it is a simple, unidimensional measure. It was developed by Price et al. in 1983 to assess perceived pain. Compared to the VAS scale, which is known to be more sensitive in the assessment and characterization of acute pain, "no pain" is rated as 0 points and "most severe pain" as 10 points. On this scale, an increase in score indicates an increase in pain. Pain is also categorized as mild (<3), moderate (3-6), and severe (>6).
Evaluation of Anxiety in Patients After Total Hip Arthroplasty Surgery
Time frame: The first 24 hours after surgery, 25-48 hours after surgery
The Spielberger State-Trait Anxiety Inventory was used to assess patients' anxiety levels. The original scale was developed in 1970 by Spielberger and his team and adapted to the Turkish language and culture by Öner and Le Compte. Scale items are answered on a four-point Likert-type scale. For the state anxiety scale, the response options are "not at all," "a little," "a lot," and "completely," while for the trait anxiety scale, they are "never," "sometimes," "most of the time," and "almost always." Higher scores on the scale indicate higher levels of anxiety, while lower scores indicate lower levels of anxiety. According to the score ranges established by Spielberger and colleagues, a score of 0-19 indicates no anxiety, 20-39 indicates mild anxiety, 40-59 indicates moderate anxiety, and 60-79 indicates severe anxiety.
Evaluation of Comfort Levels in Patients After Total Hip Arthroplasty Surgery
Time frame: The first 24 hours after surgery, 25-48 hours after surgery
The comfort levels of postoperative patients were assessed using the Perianesthesia Comfort Scale. The scale was developed by Kolcaba in 1990 and adapted into Turkish by Üstündağ and Aslan (2010). The Perianesthesia Comfort Scale (PCS) is a self-report assessment tool designed to measure individuals' comfort levels during the perianesthesia period. The scale consists of a total of 24 items and uses a six-point Likert-type scale. Participants respond to each item with scores ranging from "strongly disagree (1)" to "strongly agree (6)." The total score that can be obtained from the scale ranges from 24 to 144. The total score is divided by the number of items to calculate the mean score, which is expressed as a value between 1 and 6. A low mean score indicates a low level of comfort, while a high mean score indicates a high level of comfort.
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 8 Jul 2026.
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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.
OĞUZHAN ÇAĞLAR, MSc Std principal investigator
Adiyaman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive intervention in people with Virtual Reality and Hip Arthropathy, run by Adiyaman University 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 6 inclusion and 7 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 8 Jul 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 OĞUZHAN ÇAĞLAR, MSc Std (5423455495 ext. +90, ocaglar@adiyaman.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Pain in Patients After Total Hip Arthroplasty Surgery (time frame: The first 24 hours after surgery, 25-48 hours after surgery). The study lists 3 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 8 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.