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The Effect of Virtual Reality on Pain, Anxiety, and Fear During Burn Dressing in Children

Primary Purpose

Fear and Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
wearing virtual reality headsets
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fear and Anxiety focused on measuring anxiety, burn dressing, child, fear, pain, virtual reality

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • TURKEY

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control groups: without wearing virtual reality headsets

experimental groups

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Descriptive Information Form
The Descriptive Information Form prepared by the researcher consists of 15 questions in total.
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)
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.
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

Secondary Outcome Measures

Full Information

First Posted
August 24, 2021
Last Updated
August 31, 2021
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05032586
Brief Title
The Effect of Virtual Reality on Pain, Anxiety, and Fear During Burn Dressing in Children
Official Title
The Effect of Virtual Reality on Pain, Anxiety, and Fear During Burn Dressing in Children: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fear and Anxiety
Keywords
anxiety, burn dressing, child, fear, pain, virtual reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
parallel assigment
Masking
None (Open Label)
Masking Description
randomized
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control groups: without wearing virtual reality headsets
Arm Type
No Intervention
Arm Description
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.
Arm Title
experimental groups
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
wearing virtual reality headsets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Descriptive Information Form
Description
The Descriptive Information Form prepared by the researcher consists of 15 questions in total.
Time Frame
up to 1 hour
Title
Wong-Baker FACES Pain Rating Scale
Description
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)
Time Frame
up to 1 hour
Title
Children's Fear Scale
Description
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.
Time Frame
up to 1 hour
Title
State-Trait Anxiety Inventory for Children (STAI-C)
Description
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
Time Frame
up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
TURKEY
City
Erzurum
State/Province
Yakutiye
ZIP/Postal Code
25300
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Virtual Reality on Pain, Anxiety, and Fear During Burn Dressing in Children

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