Fear and AnxietyNCT05032586
The Effect of Virtual Reality on Pain, Anxiety, and Fear During Burn Dressing in Children
A study testing wearing virtual reality headsets in people with Fear and Anxiety, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted to determine the effect of VR on the pain, anxiety, and fear levels experienced by patients during burn dressing. The experimental (VR group) (n=33) and the control group (n=32) were determined using the simple randomization method for the children participating in the study (n=65). Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear and Anxiety
- What is being tested?
- wearing virtual reality headsets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 25 Dec 2020
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- being in the 7-12 age group,
- not having any dressing in the burn center before
- having a second degree superficial and deep burn
- having burns with a percentage of less than 10%,
- having upper and lower extremity burns
- not having any chronic disease other than burns,
- being willing to participate in the study,
- not having any mental and communication problems and visual impairments
Who cannot join
- being <7 and >12 years old
- having previous dressing in the burn center,
- having a 1st or 3rd degree burn area,
- having burns on the head, trunk, and genital area,
- having chronic illness other than burns any
- not being willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality on Pain, Anxiety, and Fear During Burn Dressing in Children: A Randomized Controlled Study
This research was conducted to determine the effect of VR on the pain, anxiety, and fear levels experienced by patients during burn dressing. The experimental (VR group) (n=33) and the control group (n=32) were determined using the simple randomization method for the children participating in the study (n=65).
Read the detailed description
Burn injuries are considered one of the most severe physical and psychosocial traumas a person can face. Burn injuries, especially in the childhood, are an important health problem that causes long-term psychological and physiological consequences and includes rehabilitation processes that continue for years.
During burn treatment, wound debridement, daily dressing change, repair surgeries, and applications during hospitalization cause serious pain, physical stress, and psychological damage to the patient in burn injuries, as in all injuries. Anxiety, loss of control, hopelessness, disruption of body integrity, and pain during burns and procedures during the treatment process are early traumatic features of the burn.
Since pain is not only a sensory experience but also an emotional and cognitive experience, using pharmacological treatment methods alone may not be sufficient. Using nonpharmacological methods in addition to pharmacological methods is recommended in order to control the pain that occurs during wound care and reduce the dose of analgesic administered. The distraction technique is one of the most frequently preferred nonpharmacological methods to reduce pain perception during dressing and control fear and anxiety in children hospitalized in the clinic due to burns. It is a method included in the Nursing Interventions Classification taxonomy.
When the literature was examined, it was observed that there are a limited number of studies examining the effect of VR on pain and anxiety in children during burn dressing. However, there was no study evaluating the fear experienced during burn dressing in children. This study aimed to propagate the use of VR, which is a potentially important technology for nursing care and multidisciplinary healthcare team and has an important place in the treatment of burn patients by reducing the level of pain and anxiety experienced by patients. It is thought that the result of the research will shed light on how to reduce pain, fear, and anxiety experienced during dressing and contribute to the literature as an evidence-based nonpharmacological method.
The research is a randomized controlled experimental study conducted between April 2019 and September 2020. The experimental (VR group) (n=33) and the control group (n=32) were determined using the simple randomization method for the children participating in the study (n=65). The data were collected using the Descriptive Information Form, Wong-Baker FACES Pain Rating Scale, Children's Fear Scale, and State-Trait Anxiety Inventory for Children. In addition, oxygen saturation and heart rate measurements were recorded before and after the procedure.
- Conditions
- Fear and Anxiety
- Being tested
- wearing virtual reality headsets
- Keywords
- anxiety, burn dressing, child, fear, pain, virtual reality
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearing virtual reality headsetsDevice
When the patient adapted to the headset and started to play games, he was taken to the dressing room with the VR headset and the application continued until the process was completed. Before starting the study, a pilot study was conducted to determine the time to wear headsets in ten children. It was observed that the children who were taken to the dressing room without wearing VR headsets refused to wear it. In order to prevent the child from experiencing anxiety in the dressing room, the child was put on VR headset in the patient room and then taken to the dressing room. After the procedure was completed, the VR headset was removed and the patient's oxygen saturation and heart rate were recorded on the "Application Registration Form." The patients were asked regarding the pain and anxiety levels felt during dressing before and after the procedure and marked on the Wong Baker Scale, State-Trait Anxiety Inventory for Children and Children's Fear Scale.
| Study group | Role | What they receive |
|---|---|---|
| control groups: without wearing virtual reality headsets | No intervention | Before dressing, the child was given paracetamol, which is routinely used to prevent pain. The child was reminded that they would be with their family during the procedure, and either the mother or father was taken to the dressing room during dressing. After the standard burn dressing was applied to the patient by the healthcare personnel in the burn center treatment room, oxygen saturation and heart rate measurements were made again after the procedure and recorded in the "Application Registration Form." Before and after the procedure, the patients were asked about the pain and anxiety levels felt during dressing and marked on the Wong Baker Scale, State-Trait Anxiety Inventory for Children and Children's Fear Scale. |
| experimental groups | Experimental | When the patient adapted to the headset and started to play games, he was taken to the dressing room with the VR headset and the application continued until the process was completed. Before starting the study, a pilot study was conducted to determine the time to wear headsets in ten children. It was observed that the children who were taken to the dressing room without wearing VR headsets refused to wear it. In order to prevent the child from experiencing anxiety in the dressing room, the child was put on VR headset in the patient room and then taken to the dressing room. After the procedure was completed, the VR headset was removed and the patient's oxygen saturation and heart rate were recorded on the "Application Registration Form." The patients were asked regarding the pain and anxiety levels felt during dressing before and after the procedure and marked on the Wong Baker Scale, State-Trait Anxiety Inventory for Children and Children's Fear Scale. Receives: Device: wearing virtual reality headsets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Information Form
The Descriptive Information Form prepared by the researcher consists of 15 questions in total.
Measured: up to 1 hour
Wong-Baker FACES Pain Rating Scale
This scale is used in children aged ≥3 to rate the severity of pain. This numerical rating scale ranges from 0 to 5. Faces show emotions from smiling (0 = very happy/no pain) to crying (5 = hurts worst)
Measured: up to 1 hour
Children's Fear Scale
This scale is a one-item self-report measure for measuring pain-related fear in children. It consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right.
Measured: up to 1 hour
State-Trait Anxiety Inventory for Children (STAI-C)
The scale was transformed into 2 separate scales containing a total of 40 items (20 state and 20 trait anxiety items) as a result of some processes. The scale was seen to be used in all school-age children who can read. The maximum score that can be obtained from the State Anxiety Inventory is 60 and the minimum score is 20
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Nov 2019
- Primary completion1 Nov 2020
- Study completion25 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear and AnxietyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Single group
- Model description
- parallel assigment
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MERVE KAYA, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032586
- Sponsor's protocol ID
- merve25
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2021
- Last updated
- 2 Sep 2021
- 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 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Pain, Anxiety, and Fear During Burn Dressing in Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05032586
- Acronym / sponsor ID
- merve25
- Conditions
- Fear and Anxiety
- Keywords
- anxiety, burn dressing, child, fear, pain, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 2 Sep 2021 (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 research was conducted to determine the effect of VR on the pain, anxiety, and fear levels experienced by patients during burn dressing. The experimental (VR group) (n=33) and the control group (n=32) were determined using the simple randomization method for the children participating in the study (n=65).
Detailed description
Burn injuries are considered one of the most severe physical and psychosocial traumas a person can face. Burn injuries, especially in the childhood, are an important health problem that causes long-term psychological and physiological consequences and includes rehabilitation processes that continue for years.
During burn treatment, wound debridement, daily dressing change, repair surgeries, and applications during hospitalization cause serious pain, physical stress, and psychological damage to the patient in burn injuries, as in all injuries. Anxiety, loss of control, hopelessness, disruption of body integrity, and pain during burns and procedures during the treatment process are early traumatic features of the burn.
Since pain is not only a sensory experience but also an emotional and cognitive experience, using pharmacological treatment methods alone may not be sufficient. Using nonpharmacological methods in addition to pharmacological methods is recommended in order to control the pain that occurs during wound care and reduce the dose of analgesic administered. The distraction technique is one of the most frequently preferred nonpharmacological methods to reduce pain perception during dressing and control fear and anxiety in children hospitalized in the clinic due to burns. It is a method included in the Nursing Interventions Classification taxonomy.
When the literature was examined, it was observed that there are a limited number of studies examining the effect of VR on pain and anxiety in children during burn dressing. However, there was no study evaluating the fear experienced during burn dressing in children. This study aimed to propagate the use of VR, which is a potentially important technology for nursing care and multidisciplinary healthcare team and has an important place in the treatment of burn patients by reducing the level of pain and anxiety experienced by patients. It is thought that the result of the research will shed light on how to reduce pain, fear, and anxiety experienced during dressing and contribute to the literature as an evidence-based nonpharmacological method.
The research is a randomized controlled experimental study conducted between April 2019 and September 2020. The experimental (VR group) (n=33) and the control group (n=32) were determined using the simple randomization method for the children participating in the study (n=65). The data were collected using the Descriptive Information Form, Wong-Baker FACES Pain Rating Scale, Children's Fear Scale, and State-Trait Anxiety Inventory for Children. In addition, oxygen saturation and heart rate measurements were recorded before and after the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel assigment
| Arm | Type | Receives |
|---|---|---|
| control groups: without wearing virtual reality headsets | No intervention | –Before dressing, the child was given paracetamol, which is routinely used to prevent pain. The child was reminded that they would be with their family during the procedure, and either the mother or father was taken to the dressing room during dressing. After the standard burn dressing was applied to the patient by the healthcare personnel in the burn center treatment room, oxygen saturation and heart rate measurements were made again after the procedure and recorded in the "Application Registration Form." Before and after the procedure, the patients were asked about the pain and anxiety levels felt during dressing and marked on the Wong Baker Scale, State-Trait Anxiety Inventory for Children and Children's Fear Scale. |
| experimental groups | Experimental | Device: wearing virtual reality headsetsWhen the patient adapted to the headset and started to play games, he was taken to the dressing room with the VR headset and the application continued until the process was completed. Before starting the study, a pilot study was conducted to determine the time to wear headsets in ten children. It was observed that the children who were taken to the dressing room without wearing VR headsets refused to wear it. In order to prevent the child from experiencing anxiety in the dressing room, the child was put on VR headset in the patient room and then taken to the dressing room. After the procedure was completed, the VR headset was removed and the patient's oxygen saturation and heart rate were recorded on the "Application Registration Form." The patients were asked regarding the pain and anxiety levels felt during dressing before and after the procedure and marked on the Wong Baker Scale, State-Trait Anxiety Inventory for Children and Children's Fear Scale. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- being in the 7-12 age group,
- not having any dressing in the burn center before
- having a second degree superficial and deep burn
- having burns with a percentage of less than 10%,
- having upper and lower extremity burns
Key exclusion criteria (6 listed)
- being <7 and >12 years old
- having previous dressing in the burn center,
- having a 1st or 3rd degree burn area,
- having burns on the head, trunk, and genital area,
- having chronic illness other than burns any
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 |
|---|---|---|
| wearing virtual reality headsetsWhen the patient adapted to the headset and started to play games, he was taken to the dressing room with the VR headset and the application continued until the process was completed. Before starting the study, a pilot study was conducted to determine the time to wear headsets in ten children. It was observed that the children who were taken to the dressing room without wearing VR headsets refused to wear it. In order to prevent the child from experiencing anxiety in the dressing room, the child was put on VR headset in the patient room and then taken to the dressing room. After the procedure was completed, the VR headset was removed and the patient's oxygen saturation and heart rate were recorded on the "Application Registration Form." The patients were asked regarding the pain and anxiety levels felt during dressing before and after the procedure and marked on the Wong Baker Scale, State-Trait Anxiety Inventory for Children and Children's Fear Scale. | Device | experimental groups |
Primary outcome
Descriptive Information Form
Time frame: up to 1 hour
The Descriptive Information Form prepared by the researcher consists of 15 questions in total.
Wong-Baker FACES Pain Rating Scale
Time frame: up to 1 hour
This scale is used in children aged ≥3 to rate the severity of pain. This numerical rating scale ranges from 0 to 5. Faces show emotions from smiling (0 = very happy/no pain) to crying (5 = hurts worst)
Children's Fear Scale
Time frame: up to 1 hour
This scale is a one-item self-report measure for measuring pain-related fear in children. It consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right.
State-Trait Anxiety Inventory for Children (STAI-C)
Time frame: up to 1 hour
The scale was transformed into 2 separate scales containing a total of 40 items (20 state and 20 trait anxiety items) as a result of some processes. The scale was seen to be used in all school-age children who can read. The maximum score that can be obtained from the State Anxiety Inventory is 60 and the minimum score is 20
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 2 Sep 2021.
- 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 wearing virtual reality headsets in people with Fear and Anxiety, run by Ataturk 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 8 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: finished, as of the sponsor's last update on 2 Sep 2021. 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?
Descriptive Information Form (time frame: up to 1 hour). The study lists 4 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 2 Sep 2021.