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

NCT05032586 | Completed

• 1 other identifier: merve25
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

Fear and Anxiety

Keywords

anxiety; burn dressing; child; fear; pain; virtual reality

Outcome Measures

Primary Outcomes (4)

• Descriptive Information Form

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

  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)

  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.

  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

  up to 1 hour

Study Arms (2)

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.

Device: wearing virtual reality headsets

Interventions

wearing virtual reality headsets DEVICE

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.

experimental groups

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

TURKEY

Erzurum, Yakutiye, 25300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: randomized
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ataturk University

Model Details: parallel assigment

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 2, 2021
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 25, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)