The Effect of Virtual Reality Headset Use on Pain, Comfort, and Psychosocial Symptoms in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- wong-baker faces scale
Study Overview
Brief Summary
The aim of this study is to examine the effect of virtual reality glasses use on pain, comfort, and psychosocial symptoms in children after hypospadias surgery.
Detailed Description
This research was conducted as a randomized controlled trial, with a sample consisting of 62 pediatric patients (intervention group = 31, control group = 31) undergoing hypospadias surgery. Virtual reality headsets were administered to the intervention group postoperatively, while the control group received routine care. Data were collected using a Descriptive Information Form, the Wong-Baker FACES Scale, the Pediatric Comfort Assessment Scale, and the Psychosocial Symptom Identification Scale for Hospitalized Children. Data were analyzed using the IBM SPSS Statistics 22.0 software package. Descriptive statistics, independent samples t-test, chi-square test, and mixed-design repeated measures analysis were employed for data analysis. Statistical significance was set at p<0.05.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must provide written and verbal informed consent from their parents for participation in the study, and be male children aged 6-12 who have undergone hypospadias surgery.
Exclusion Criteria
- •Having an auditory, mental, neurological, or visual impairment/problem severe enough to prevent VR glasses use, using an additional analgesic outside of the standard protocol within the first hour after surgery, or experiencing nausea, dizziness, or excessive panic reactions related to the virtual reality glasses during the procedure.
Arms & Interventions
control group
routine clinical practice
Intervention: routine clinical practice (Other)
intervention group
playing a 15-minute game through virtual reality glasses
Intervention: Virtual reality headset (Device)
Outcomes
Primary Outcomes
wong-baker faces scale
Time Frame: 1 hour after surgery/before and after application/2 times a day/10-15 minutes
The assessment was conducted using the Wong-Baker Faces Scale. On the scale, the lowest score is "0" and the highest is "10." Pain intensity increases as the score rises. When administering the scale, an explanation is provided to the child using facial expressions, and the child is asked to select the expression that best reflects their condition. The scale scores are interpreted as follows: 0 = no pain; 2 = mild pain; 4 = some pain; 6 = distinct pain; 8 = severe pain; and 10 = unbearable pain.
pediatric comfort assessment scale
Time Frame: 1 hour after surgery/before and after application/2 times a day/10-15 minutes
The assessment was conducted using the pediatric comfort assessment scale. It evaluates 5 parameters: sounds, motor movements, performance, facial expressions and other. Each item is evaluated on a 5-point Likert scale from 0 to 4 (0/Not Available, 1/No, 2/Somewhat, 3/Moderate, 4/Strong) from bad to good. Higher scores indicate a higher level of comfort.
Secondary Outcomes
- Psychosocial symptom assessment scale for hospitalized children(1 hour after surgery/before and after application/2 times a day/10-15 minutes)
Investigators
aysel kokcudogan
Ph.D., Asst. Prof.
Istanbul Medipol University Hospital