PAINNCT05688891
Burn Patient Care, Virtual Reality, Music, Pain, Anxiety and Pain Anxiety
A study testing Virtual reality and Music in people with PAIN and ANXIETY, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Different non-pharmacological methods such as virtual reality glasses and music can be applied by nurses within the scope of care interventions for the management of pain and anxiety in burn patients during dressing changes and debridement. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PAIN, ANXIETY, PAIN ANXIETY
- What is being tested?
- Virtual reality and Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2022to 17 Nov 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be between the ages of 18-65,
- Ability to read, write and speak Turkish,
- Not participating in another clinical trial at the same time,
- Not having any problems that prevent cognitive, affective and verbal communication,
- Having a patient group with a burnt total body area (TBSA) of less than 15%,
- 2nd degree and 3rd degree patient group in the granulation stage,
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- No burns on the head, ears and face,
- Being a patient group with daily dressing changes and dressing frequency of 1-15,
- Absence of complaints such as respiratory problems that would prevent him from participating in the study,
- Absence of vision and hearing problems.
Who cannot join
- Pain intensity is between 8-10 points,
- Being under the influence of pharmacological or non-pharmacological intervention that will affect the pain,
- Being a first degree patient group,
- Having neurological, psychological and psychiatric diseases,
- Burns on the head, ears and face,
- Having vision and hearing problems,
Show all 9Show fewer
- Applying sedation to the patient during the dressing,
- Stop watching VR glasses during dressing,
- Stop listening to music during dressing.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkey, Istanbul University-Cerrahpasa
Istanbul
About this study
Official title: The Effect of Virtual Reality and Music on Pain, Anxiety and Pain Anxiety in Burn Patient Care
Different non-pharmacological methods such as virtual reality glasses and music can be applied by nurses within the scope of care interventions for the management of pain and anxiety in burn patients during dressing changes and debridement.
In this study, it was aimed to determine the effect of virtual reality and music on pain, anxiety and pain anxiety in burn patient care.
Read the detailed description
Wound debridement, wound care, surgical interventions and other invasive procedures applied during burn treatment cause the patient to feel pain, and the repeated pain process creates anxiety in the patient.
In the studies in the literature, it is stated that anxiety and pain are closely related, pain affects the level of anxiety and anxiety affects the severity of pain.
The role of nurses in the burn team is very important in the management of pain and anxiety in the treatment of burns, which have both physiological and psychological effects.
The most important responsibility of the nurse in burn patient care is continuous and individualized pain diagnosis and management.
Different non-pharmacological methods such as virtual reality glasses and music can be applied by nurses within the scope of care interventions for the management of pain and anxiety.
Music is widely used to reduce pain and anxiety in burn patients during dressing changes and debridement.
Virtual reality (VR) glasses, which facilitate daydreaming and daydreaming, are another method used to reduce pain and anxiety. With the development of technology, the use of virtual reality glasses by nurses as a method of distraction, especially in burn patients, is increasing.
In this study, it was aimed to determine the effect of virtual reality and music on pain, anxiety and pain anxiety in burn patient care.
The sample group was selected in accordance with the research criteria from the individuals in the population who were given permission to participate in the research after the purpose of the research was explained.
Within the scope of the planned study, the sample size to be used in determining the effect of virtual reality and music on pain, anxiety and pain anxiety in burn patient care, effect size d= 0.485 (effect size), α=0.05 ( margin of error), 1-β With the help of the G-power (version 3.1) package program, a total of 120 people (at least 40 people in each group) were calculated, as =0.80 (power).
A list was created for 120 patients who met the inclusion criteria in the study and distributed to the experimental and control groups using a computerized randomization program.
- Conditions
- PAIN, ANXIETY, PAIN ANXIETY
- Being tested
- Virtual reality, Music
- Keywords
- Burn care, Pain, Anxiety, Pain anxiety, Nursing
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
5 minutes before the burn dressing procedure, virtual reality glasses were put on the patient's head by the researcher and a 360° VR video with submarine and nature content pre-loaded on the glasses was opened.
Audio and video settings were made and started to be watched. Video monitoring with Virtual Reality continued throughout the entire dressing. This procedure was performed during 2 consecutive dressing changes. A 1-week period was given between 2 dressings.
MusicOther
5 minutes before the burn dressing procedure, the patient was asked about the type of music he preferred in the introductory patient information form. Then, the patient was started to listen after putting on headphones and adjusting the volume. The patient was asked to keep his eyes closed while listening to music. Music listening was continued throughout the entire dressing.
After the process was finished, the music was turned off and the headphones were removed.
This procedure was performed during 2 dressing changes in accordance with clinical treatment and protocols.
A 1-week period was given between 2 dressings.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Before the procedure, "Visual Analogue Scale-VAS", "Spielberger State and Trait Anxiety Inventory", "Burn-Specific Pain Anxiety Scale" were filled in.5 minutes before the burn dressing procedure, virtual reality glasses were put on the patient's head by the researcher and a 360° VR video with submarine and nature content pre-loaded on the glasses was opened.
Video monitoring with Virtual Reality continued throughout the entire dressing.This procedure was performed during 2 consecutive dressing changes. A 1-week period was given between 2 dressings.After the procedure, the scales were filled again. Receives: Other: Virtual reality |
| Music | Experimental | 5 minutes before the burn dressing procedure, the patient was asked about the type of music he preferred in the introductory patient information form. Then, the patient was started to listen after putting on headphones and adjusting the volume. The patient was asked to keep his eyes closed while listening to music. Music listening was continued throughout the entire dressing.This procedure was performed during 2 dressing changes in accordance with clinical treatment and protocols.
A 1-week period was given between 2 dressings.After the procedure, the scales were filled again. Receives: Other: Music |
| Control | No intervention | During the burn dressing procedure, no intervention method was used, and routine treatment and care interventions were continued.This procedure was performed during 2 dressing changes in accordance with clinical treatment and protocols. A 1-week period was given between 2 dressings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluated using Visual Analog Scale
Visual Analog Scale (VAS) is the most frequently used and simplest to use scale. In the scale with numbers between 0-10, "0" defines painlessness and "10" defines the most severe pain.
In order to define the numerical value of the patient's pain/anxiety severity, the patient is asked to mark the ruler consisting of a 10 cm line, and the patient's pain severity score is determined as a result of the measurement.
The scale consists of five parts. Each of the sections is in the range of 2 points. '0' points - no pain, '1-2 points, very mild pain', '3-4 points, mild pain', '5-6 points, moderate pain', '7-8 points, severe pain' means '9-10 points, excruciating pain'.
Measured: Change from baseline (before implementation) and 2th week of practice
Anxiety evaluated using The State Anxiety Inventory
It is a self-assessment scale consisting of twenty items developed by Spielberger et al. (1970) to determine state anxiety levels. The Turkish validity and reliability study of this scale was performed by Öner and LeCompte (1977), and the internal consistency (Cronbach's Alpha) coefficients were found to be between 0.83 and 0.92 for the state anxiety scale (Öner \& LeCompte, 1998). Higher total scores on the scale indicate a high level of state anxiety.
The response options collected in four classes in the state anxiety scale are (1) Not at all, (2) Somewhat, (3) A lot, and (4) Completely. There are ten reversed statements in the state anxiety scale. These are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20.
The scores obtained in the scale theoretically vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
Measured: Change from baseline (before implementation) and 2th week of practice
Pain Anxiety evaluated using The Burn Specific Pain Anxiety Scale (BSPAS)
The Burn Specific Pain Anxiety Scale (BSPAS) is another tool which evaluates pain related anxiety in burn patients. For each question in this scale, 0 "never" and 10 "worst possible" are accepted. The scale total score is calculated by summing the scores of all items and the lowest score is 0 and the highest score is 80. The higher the total score, the higher the anxiety experienced by the patient about painful procedures while in the hospital.
Measured: Change from baseline (before implementation) and 2th week of practice
Secondary outcomes (1)
Anxiety evaluated using The Trait Anxiety Inventory
In the trait anxiety scale, the number of reversed statements is seven and these make up the items 21, 26, 27, 30, 33, 36 and 39. On the trait anxiety scale, reversed statements the number of statements is seven and these make up Articles 21, 26, 27, 30, 33, 36 and 39.
The scores obtained from both scales theoretically vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. The same is true when interpreting scores in percentile order. That is, the low percentile rank (1, 5, 10) indicates less anxiety. The average score level determined in the applications varies between 36 and 41.
Measured: State from baseline (before implementation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start14 Mar 2022
- Primary completion14 Jan 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAINStudies 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
- prospective randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. SEHER DENİZ ÖZTEKİN
- Responsible party
- Principal investigator, RABİA GÖRÜCÜ, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688891
- Sponsor's protocol ID
- 2022/514/221/7
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality and Music on Pain, Anxiety and Pain Anxiety in Burn Patient Care
- ClinicalTrials.gov ID
- NCT05688891
- Acronym / sponsor ID
- 2022/514/221/7
- Conditions
- PAIN, ANXIETY, PAIN ANXIETY
- Keywords
- Burn care, Pain, Anxiety, Pain anxiety, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Collaborators
- Prof. Dr. SEHER DENİZ ÖZTEKİN
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 14 Jan 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 18 Jan 2023 (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.
Different non-pharmacological methods such as virtual reality glasses and music can be applied by nurses within the scope of care interventions for the management of pain and anxiety in burn patients during dressing changes and debridement.
In this study, it was aimed to determine the effect of virtual reality and music on pain, anxiety and pain anxiety in burn patient care.
Detailed description
Wound debridement, wound care, surgical interventions and other invasive procedures applied during burn treatment cause the patient to feel pain, and the repeated pain process creates anxiety in the patient.
In the studies in the literature, it is stated that anxiety and pain are closely related, pain affects the level of anxiety and anxiety affects the severity of pain.
The role of nurses in the burn team is very important in the management of pain and anxiety in the treatment of burns, which have both physiological and psychological effects.
The most important responsibility of the nurse in burn patient care is continuous and individualized pain diagnosis and management.
Different non-pharmacological methods such as virtual reality glasses and music can be applied by nurses within the scope of care interventions for the management of pain and anxiety.
Music is widely used to reduce pain and anxiety in burn patients during dressing changes and debridement.
Virtual reality (VR) glasses, which facilitate daydreaming and daydreaming, are another method used to reduce pain and anxiety. With the development of technology, the use of virtual reality glasses by nurses as a method of distraction, especially in burn patients, is increasing.
In this study, it was aimed to determine the effect of virtual reality and music on pain, anxiety and pain anxiety in burn patient care.
The sample group was selected in accordance with the research criteria from the individuals in the population who were given permission to participate in the research after the purpose of the research was explained.
Within the scope of the planned study, the sample size to be used in determining the effect of virtual reality and music on pain, anxiety and pain anxiety in burn patient care, effect size d= 0.485 (effect size), α=0.05 ( margin of error), 1-β With the help of the G-power (version 3.1) package program, a total of 120 people (at least 40 people in each group) were calculated, as =0.80 (power).
A list was created for 120 patients who met the inclusion criteria in the study and distributed to the experimental and control groups using a computerized randomization program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- prospective randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Other: Virtual realityBefore the procedure, "Visual Analogue Scale-VAS", "Spielberger State and Trait Anxiety Inventory", "Burn-Specific Pain Anxiety Scale" were filled in.5 minutes before the burn dressing procedure, virtual reality glasses were put on the patient's head by the researcher and a 360° VR video with submarine and nature content pre-loaded on the glasses was opened. Video monitoring with Virtual Reality continued throughout the entire dressing.This procedure was performed during 2 consecutive dressing changes. A 1-week period was given between 2 dressings.After the procedure, the scales were filled again. |
| Music | Experimental | Other: Music5 minutes before the burn dressing procedure, the patient was asked about the type of music he preferred in the introductory patient information form. Then, the patient was started to listen after putting on headphones and adjusting the volume. The patient was asked to keep his eyes closed while listening to music. Music listening was continued throughout the entire dressing.This procedure was performed during 2 dressing changes in accordance with clinical treatment and protocols. A 1-week period was given between 2 dressings.After the procedure, the scales were filled again. |
| Control | No intervention | –During the burn dressing procedure, no intervention method was used, and routine treatment and care interventions were continued.This procedure was performed during 2 dressing changes in accordance with clinical treatment and protocols. A 1-week period was given between 2 dressings. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- be between the ages of 18-65,
- Ability to read, write and speak Turkish,
- Not participating in another clinical trial at the same time,
- Not having any problems that prevent cognitive, affective and verbal communication,
- Having a patient group with a burnt total body area (TBSA) of less than 15%,
Key exclusion criteria (9 listed)
- Pain intensity is between 8-10 points,
- Being under the influence of pharmacological or non-pharmacological intervention that will affect the pain,
- Being a first degree patient group,
- Having neurological, psychological and psychiatric diseases,
- Burns on the head, ears and face,
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 reality5 minutes before the burn dressing procedure, virtual reality glasses were put on the patient's head by the researcher and a 360° VR video with submarine and nature content pre-loaded on the glasses was opened. Audio and video settings were made and started to be watched. Video monitoring with Virtual Reality continued throughout the entire dressing. This procedure was performed during 2 consecutive dressing changes. A 1-week period was given between 2 dressings. | Other | Virtual reality |
| Music5 minutes before the burn dressing procedure, the patient was asked about the type of music he preferred in the introductory patient information form. Then, the patient was started to listen after putting on headphones and adjusting the volume. The patient was asked to keep his eyes closed while listening to music. Music listening was continued throughout the entire dressing. After the process was finished, the music was turned off and the headphones were removed. This procedure was performed during 2 dressing changes in accordance with clinical treatment and protocols. A 1-week period was given between 2 dressings. | Other | Music |
Primary outcome
Pain evaluated using Visual Analog Scale
Time frame: Change from baseline (before implementation) and 2th week of practice
Visual Analog Scale (VAS) is the most frequently used and simplest to use scale. In the scale with numbers between 0-10, "0" defines painlessness and "10" defines the most severe pain. In order to define the numerical value of the patient's pain/anxiety severity, the patient is asked to mark the ruler consisting of a 10 cm line, and the patient's pain severity score is determined as a result of the measurement. The scale consists of five parts. Each of the sections is in the range of 2 points. '0' points - no pain, '1-2 points, very mild pain', '3-4 points, mild pain', '5-6 points, moderate pain', '7-8 points, severe pain' means '9-10 points, excruciating pain'.
Anxiety evaluated using The State Anxiety Inventory
Time frame: Change from baseline (before implementation) and 2th week of practice
It is a self-assessment scale consisting of twenty items developed by Spielberger et al. (1970) to determine state anxiety levels. The Turkish validity and reliability study of this scale was performed by Öner and LeCompte (1977), and the internal consistency (Cronbach's Alpha) coefficients were found to be between 0.83 and 0.92 for the state anxiety scale (Öner \& LeCompte, 1998). Higher total scores on the scale indicate a high level of state anxiety. The response options collected in four classes in the state anxiety scale are (1) Not at all, (2) Somewhat, (3) A lot, and (4) Completely. There are ten reversed statements in the state anxiety scale. These are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The scores obtained in the scale theoretically vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
Pain Anxiety evaluated using The Burn Specific Pain Anxiety Scale (BSPAS)
Time frame: Change from baseline (before implementation) and 2th week of practice
The Burn Specific Pain Anxiety Scale (BSPAS) is another tool which evaluates pain related anxiety in burn patients. For each question in this scale, 0 "never" and 10 "worst possible" are accepted. The scale total score is calculated by summing the scores of all items and the lowest score is 0 and the highest score is 80. The higher the total score, the higher the anxiety experienced by the patient about painful procedures while in the hospital.
1 secondary outcome
Anxiety evaluated using The Trait Anxiety Inventory
Time frame: State from baseline (before implementation)
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 10 Dec 2025.
- 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.
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 and Music in people with PAIN and ANXIETY, run by Karabuk 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 10 inclusion and 9 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 10 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 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?
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?
Pain evaluated using Visual Analog Scale (time frame: Change from baseline (before implementation) and 2th week of practice). 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 10 Dec 2025.