BurnsNCT07306442
VR for Pain & Sleep in Burn Patients: A RCT
A study testing Virtual Reality Distraction in people with Burns and Pain, run by Abadan University of Medical Sciences at 1 site in Iran.
Trial summary
This study aims to evaluate whether virtual reality (VR) can reduce pain and improve sleep quality during wound dressing changes in burn patients with 25-60% total body surface area (TBSA) burns, compared to standard care. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burns, Pain, Sleep Disturbances
- What is being tested?
- Virtual Reality Distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2025to 1 Jun 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Adult patients aged 18 to 60 years.
- Deep partial-thickness or full-thickness burns covering 25% to 60% of total body surface area (TBSA).
- Hemodynamic stability (systolic BP ≥90 mmHg, HR 60-100 bpm, no vasopressor use).
- Ability to understand and comprehend Persian language.
- Scheduled for at least one standardized, non-sedated wound dressing change procedure.
Who cannot join
- - Diagnosed psychiatric or neurological disorder (e.g., schizophrenia, epilepsy).
- Severe visual impairment (best-corrected visual acuity <20/200) or auditory impairment.
- History of motion sickness or VR intolerance.
- Contraindications to VR use (e.g., active vertigo, uncontrolled hypertension).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Abadan University of Medical Sciences
This study aims to evaluate whether virtual reality (VR) can reduce pain and improve sleep quality during wound dressing changes in burn patients with 25-60% total body surface area (TBSA) burns, compared to standard care.
Read the detailed description
Background:
Burn injuries are extremely painful, especially during wound dressing changes. They also cause severe sleep problems, which can slow down healing. While medicines help, they often have side effects and don't fully solve these issues. Virtual reality (VR) is a new tool that distracts the brain from pain by immersing patients in a calming digital world. This study was designed to assess if VR could help with both pain and sleep in burn patients.
Methods:
We conducted a randomized controlled trial with 60 adult burn patients who had between 25% and 60% of their body burned. All patients were stable and able to understand instructions. We randomly assigned them into two groups: one group used VR headsets during their dressing changes, and the other group received standard care without VR. Pain was measured before and after the procedure using a simple 0-to-10 scale. Sleep quality was assessed using a standard questionnaire (PSQI) before and 24 hours after the treatment.
- Conditions
- Burns, Pain, Sleep Disturbances
- Being tested
- Virtual Reality Distraction, Standard Care
- Keywords
- Virtual reality, Non-pharmacological intervention, Wound dressing, Tbsa
- Medical subject headings
- Burns, Pain, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DistractionBehavioural
Also called VR Therapy
Participants in the experimental group received immersive virtual reality distraction during their wound dressing change procedure. They wore an Oculus Quest 2 headset and were immersed in a calming, interactive virtual environment (e.g., a peaceful beach or forest) for the duration of the dressing change (approximately 30-45 minutes). The audio was enabled to enhance immersion. This intervention aimed to reduce procedural pain and improve sleep quality through cognitive distraction and relaxation.
Standard CareOther
Also called Routine Burn Care
Participants in the control group received standard care during their wound dressing change, which included verbal reassurance and routine analgesic administration as prescribed, without any additional distraction techniques such as virtual reality. No specific intervention was administered beyond standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Intervention Group | Experimental | Participants in this group received immersive virtual reality distraction during their wound dressing change procedure. They wore an Oculus Quest 2 headset and were immersed in a calming, interactive virtual environment (e.g., a peaceful beach or forest) for the duration of the dressing change (approximately 30-45 minutes). The audio was enabled to enhance immersion. Receives: Behavioral: Virtual Reality Distraction; Other: Standard Care |
| Standard Care Group | Placebo comparator | Participants in this group received standard care during their wound dressing change, which included verbal reassurance and routine analgesic administration as prescribed, without any additional distraction techniques such as virtual reality. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score
The primary outcome for sleep quality was the change in the total score of the Pittsburgh Sleep Quality Index (PSQI) from baseline to 24 hours post-intervention. The PSQI is a validated self-report questionnaire assessing seven components of sleep quality over the past month. A higher score indicates poorer sleep quality. The change score (post-intervention minus pre-intervention) was calculated, with negative values indicating improvement.
Measured: 24 hours post-intervention
Change in Visual Analog Scale (VAS) Pain Score
The primary outcome for pain was the change in the Visual Analog Scale (VAS) score from immediately before to immediately after the wound dressing change procedure. The VAS is a 10-cm scale where 0 represents "no pain" and 10 represents "worst pain imaginable." The change score (post-procedure minus pre-procedure) was calculated, with negative values indicating pain reduction.
Measured: Immediately before and after the dressing change procedure
Secondary outcomes (1)
Change in individual components of the Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes included changes in each of the seven individual components of the PSQI: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. These were assessed at baseline and 24 hours post-intervention.
Measured: 24 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Jan 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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
- This is a two-arm, parallel-group, randomized controlled trial comparing virtual reality intervention with standard care in burn patients.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abadan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasool Paygozar, Abadan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306442
- Sponsor's protocol ID
- 2004
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, but only for specific purposes or under certain conditions Individual participant data (IPD) will be made available upon reasonable request to the corresponding author. Data sharing is subject to approval by the Ethics Committee of Abadan University of Medical Sciences and may require a formal data use agreement. Requests should include a detailed research proposal and must comply with local ethical and legal regulations.
Publications
Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7.
PubMed 21264690Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abadan University of Medical Sciences
- ClinicalTrials.gov ID
- NCT07306442
- Acronym / sponsor ID
- 2004
- Conditions
- Burns, Pain, Sleep Disturbances
- Keywords
- Virtual reality, Non-pharmacological intervention, Wound dressing, Tbsa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abadan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 29 Dec 2025 (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.
This study aims to evaluate whether virtual reality (VR) can reduce pain and improve sleep quality during wound dressing changes in burn patients with 25-60% total body surface area (TBSA) burns, compared to standard care.
Detailed description
Background:
Burn injuries are extremely painful, especially during wound dressing changes. They also cause severe sleep problems, which can slow down healing. While medicines help, they often have side effects and don't fully solve these issues. Virtual reality (VR) is a new tool that distracts the brain from pain by immersing patients in a calming digital world. This study was designed to assess if VR could help with both pain and sleep in burn patients.
Methods:
We conducted a randomized controlled trial with 60 adult burn patients who had between 25% and 60% of their body burned. All patients were stable and able to understand instructions. We randomly assigned them into two groups: one group used VR headsets during their dressing changes, and the other group received standard care without VR. Pain was measured before and after the procedure using a simple 0-to-10 scale. Sleep quality was assessed using a standard questionnaire (PSQI) before and 24 hours after the treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group, randomized controlled trial comparing virtual reality intervention with standard care in burn patients.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Intervention Group | Experimental | Behavioral: Virtual Reality Distraction, Other: Standard CareParticipants in this group received immersive virtual reality distraction during their wound dressing change procedure. They wore an Oculus Quest 2 headset and were immersed in a calming, interactive virtual environment (e.g., a peaceful beach or forest) for the duration of the dressing change (approximately 30-45 minutes). The audio was enabled to enhance immersion. |
| Standard Care Group | Placebo comparator | Other: Standard CareParticipants in this group received standard care during their wound dressing change, which included verbal reassurance and routine analgesic administration as prescribed, without any additional distraction techniques such as virtual reality. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- - Adult patients aged 18 to 60 years.
- Deep partial-thickness or full-thickness burns covering 25% to 60% of total body surface area (TBSA).
- Hemodynamic stability (systolic BP ≥90 mmHg, HR 60-100 bpm, no vasopressor use).
- Ability to understand and comprehend Persian language.
- Scheduled for at least one standardized, non-sedated wound dressing change procedure.
Key exclusion criteria (4 listed)
- - Diagnosed psychiatric or neurological disorder (e.g., schizophrenia, epilepsy).
- Severe visual impairment (best-corrected visual acuity <20/200) or auditory impairment.
- History of motion sickness or VR intolerance.
- Contraindications to VR use (e.g., active vertigo, uncontrolled hypertension).
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 DistractionAlso: VR TherapyParticipants in the experimental group received immersive virtual reality distraction during their wound dressing change procedure. They wore an Oculus Quest 2 headset and were immersed in a calming, interactive virtual environment (e.g., a peaceful beach or forest) for the duration of the dressing change (approximately 30-45 minutes). The audio was enabled to enhance immersion. This intervention aimed to reduce procedural pain and improve sleep quality through cognitive distraction and relaxation. | Behavioural | Virtual Reality Intervention Group |
| Standard CareAlso: Routine Burn CareParticipants in the control group received standard care during their wound dressing change, which included verbal reassurance and routine analgesic administration as prescribed, without any additional distraction techniques such as virtual reality. No specific intervention was administered beyond standard clinical practice. | Other | Standard Care Group, Virtual Reality Intervention Group |
Primary outcome
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score
Time frame: 24 hours post-intervention
The primary outcome for sleep quality was the change in the total score of the Pittsburgh Sleep Quality Index (PSQI) from baseline to 24 hours post-intervention. The PSQI is a validated self-report questionnaire assessing seven components of sleep quality over the past month. A higher score indicates poorer sleep quality. The change score (post-intervention minus pre-intervention) was calculated, with negative values indicating improvement.
Change in Visual Analog Scale (VAS) Pain Score
Time frame: Immediately before and after the dressing change procedure
The primary outcome for pain was the change in the Visual Analog Scale (VAS) score from immediately before to immediately after the wound dressing change procedure. The VAS is a 10-cm scale where 0 represents "no pain" and 10 represents "worst pain imaginable." The change score (post-procedure minus pre-procedure) was calculated, with negative values indicating pain reduction.
1 secondary outcome
Change in individual components of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 24 hours post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 21264690Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Individual participant dataSharing planned: Yes. Yes, but only for specific purposes or under certain conditions Individual participant data (IPD) will be made available upon reasonable request to the corresponding author. Data sharing is subject to approval by the Ethics Committee of Abadan University of Medical Sciences and may require a formal data use agreement. Requests should include a detailed research proposal and must comply with local ethical and legal regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Distraction in people with Burns and Pain, run by Abadan University of Medical Sciences at 1 site in Iran.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 29 Dec 2025. 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 Iran. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score (time frame: 24 hours post-intervention). 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?
On the ClinicalTrials.gov record for NCT07306442, which also lists 2 linked publications.
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 29 Dec 2025.