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Virtual Reality Intervention in Children After Hypospadias Surgery

The Effect of Virtual Reality Headset Use on Pain, Comfort, and Psychosocial Symptoms in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07752680
Enrollment
62
Registered
2026-08-07
Start date
2025-12-05
Completion date
2026-06-30
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comfort, Pain, Psychosocial Symptoms

Keywords

Pain, Hypospadias, Comfort, Psychosocial symptoms, Virtual reality headset

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.

Interventions

DEVICEVirtual reality headset

One hour after the hypospadias surgery was completed and the child arrived at the ward, the children in the intervention group were fitted with Meta Quest 3 VR headsets, the procedure of which had been explained to them beforehand. The "V-SPEEDWAY" car racing game was opened through the headsets, allowing the children to play the game continuously for approximately 15 minutes. During this 15-minute VR experience, no painful medical interventions such as dressing changes or catheter insertion were performed on the child; the child was completely focused on the virtual world.

Children in the control group were not subjected to any technological or additional distracting procedures in the first hour after surgery; they only underwent routine clinical monitoring in the ward.

Sponsors

Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Intervention model description

A randomized controlled trial.

Eligibility

Sex/Gender
MALE
Age
6 Years to 12 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
wong-baker faces scale1 hour after surgery/before and after application/2 times a day/10-15 minutesThe 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 scale1 hour after surgery/before and after application/2 times a day/10-15 minutesThe 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

MeasureTime frameDescription
Psychosocial symptom assessment scale for hospitalized children1 hour after surgery/before and after application/2 times a day/10-15 minutesThe assessment was conducted using the Psychosocial Symptom Identification Scale for Hospitalized Children. Each item in the 24-item, 3-point Likert-type scale was evaluated as "never," "sometimes," or "frequently" and scored as 0, 1, and 2, respectively. The maximum score obtainable on the scale is 48, and the minimum score is 0. A high scale score indicates the presence of psychosocial problems in the hospitalized child.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORAysel Kokcu Dogan

Faculty Member

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026