- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05032586
The Effect of Virtual Reality on Pain, Anxiety, and Fear During Burn Dressing in Children
The Effect of Virtual Reality on Pain, Anxiety, and Fear During Burn Dressing in Children: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Yakutiye
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Erzurum, Yakutiye, Turkey, 25300
- Turkey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control groups: without wearing virtual reality headsets
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.
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|
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Experimental: experimental groups
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Descriptive Information Form
Time Frame: up to 1 hour
|
The Descriptive Information Form prepared by the researcher consists of 15 questions in total.
|
up to 1 hour
|
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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)
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up to 1 hour
|
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Children's Fear Scale
Time Frame: up to 1 hour
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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.
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up to 1 hour
|
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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
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up to 1 hour
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- merve25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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