ClinicalTrials.gg
CompletedNCT07752680Updated Aug 7, 2026

Virtual Reality Intervention in Children After Hypospadias Surgery

An interventional study of Virtual reality headset and routine clinical practice in Pain, Comfort and Psychosocial Symptoms, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2025, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 30 studies in Pain by Istanbul Medipol University Hospital — 2 open to participants now, 2 under way, none of them phase 3. Pain · Istanbul Medipol University Hospital.

Enrollment
10th of 24
62 · median 60
Started
2025
with 6 others
No phase
24 of 30
1 open now
Registered
29th of 30
by date

Among the 30 studies in Pain by Istanbul Medipol University Hospital, this one is the 10th largest by enrollment of the 24 interventional ones that give a count, is one of 7 that started in 2025, is one of 24 with no phase, and was the 29th registered.

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

Browse Pain studies →

Open to participants now

2 of the 30 studies in Pain by Istanbul Medipol University Hospital are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.

This study: 6 Years to 12 Years · male · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in Pain by Istanbul Medipol University Hospital, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Pain
  • Comfort
  • Psychosocial Symptoms

Keywords

  • Pain
  • Hypospadias
  • Comfort
  • Psychosocial symptoms
  • Virtual reality headset
04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must provide written and verbal from their parents for participation in the study, and be male children aged 6-12 who have undergone hypospadias surgery.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    control group

    routine clinical practice

    Other: routine clinical practice

  • Experimental
    intervention group

    playing a 15-minute game through virtual reality glasses

    Device: Virtual reality headset

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.

  • Otherroutine clinical practice

    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.

06

What researchers measure

Primary outcomes

  1. wong-baker faces scale

    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.

    Time frame: 1 hour after surgery/before and after application/2 times a day/10-15 minutes

  2. pediatric comfort assessment scale

    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.

    Time frame: 1 hour after surgery/before and after application/2 times a day/10-15 minutes

Secondary outcomes

  1. Psychosocial symptom assessment scale for hospitalized children

    The 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.

    Time frame: 1 hour after surgery/before and after application/2 times a day/10-15 minutes

07

Study locations

1 site
  • Medipol University
    Istanbul, Beykoz 34810, Turkey (Türkiye)
08

References and documents

Publications

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  • European Association of Urology. (2026). Paediatric urology guidelines: Hypospadias. EAU Guidelines Office. Retrieved July 3, 2026, from https://uroweb.org/guidelines/paediatric-urology/chapter/hypospadias
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  • Kolcaba K, DiMarco MA. Comfort Theory and its application to pediatric nursing. Pediatr Nurs. 2005 May-Jun;31(3):187-94. PubMed 16060582 ↗
  • Kolcaba K, Wilson L. Comfort care: a framework for perianesthesia nursing. J Perianesth Nurs. 2002 Apr;17(2):102-11; quiz 111-3. doi: 10.1053/jpan.2002.31657. PubMed 11925582 ↗
  • Kökcü Doğan, A., Avcı, Ö., & Kuğuoğlu, S. (2025). Turkish validity and reliability study of the Pediatric Comfort Assessment Scale. Ege University Faculty of Nursing Journal, 41(1), 136-146. https://doi.org/10.53490/egehemsire.1260623
  • Kurban, B., & Konuk Şener, D. (2024). The effect of virtual reality glasses on pain and anxiety levels during vaccine injection in children aged 6-12 years: Randomized controlled trial. Journal of Health Academics, 11(1), 108-117. https://doi.org/10.52880/sagakaderg.1377204
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  • Li J, Fan X, Deng Q, Sun J, Jin L, Chen P, Wei P, Liu A. Significance of Continuous Nursing of Omaha System in Children after Hypospadias Surgery and Its Influence on Infection Complications. Contrast Media Mol Imaging. 2022 Sep 1;2022:8346848. doi: 10.1155/2022/8346848. eCollection 2022. PubMed 36105447 ↗
  • Li WH, Chung JO, Ho EK. The effectiveness of therapeutic play, using virtual reality computer games, in promoting the psychological well-being of children hospitalised with cancer. J Clin Nurs. 2011 Aug;20(15-16):2135-43. doi: 10.1111/j.1365-2702.2011.03733.x. Epub 2011 Jun 8. PubMed 21651633 ↗
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  • Litwin SP, Nguyen C, Hundert A, Stuart S, Liu D, Maguire B, Matava C, Stinson J. Virtual Reality to Reduce Procedural Pain During IV Insertion in the Pediatric Emergency Department: A Pilot Randomized Controlled Trial. Clin J Pain. 2021 Feb 1;37(2):94-101. doi: 10.1097/AJP.0000000000000894. PubMed 33177370 ↗
  • Luo R, Zuo Y, Liu HB, Pan Y. Postoperative behavioral changes in Chinese children undergoing hypospadias repair surgery: A prospective cohort study. Paediatr Anaesth. 2019 Feb;29(2):144-152. doi: 10.1111/pan.13539. Epub 2018 Dec 23. PubMed 30365242 ↗
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  • Oktavia Karundeng, J., Nurhaeni, N., & Wanda, D. (2022). Application of Kolcaba theory in child patients with pain problems in the infection room. Journal of Ners Community, 13(4), 403-409. https://doi.org/10.55129/jnerscommunity.v13i4.1966
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  • Olson, C. K. (2010). Children's motivations for video game play in the context of normal development. Review of General Psychology, 14(2), 180-187.
  • Pfeil, M., Parr, J., Kulkarni, M., & Mathur, A. B. (2012). Hypospadias repair: The nursing contribution. International Journal of Urological Nursing, 6, 152-158. https://doi.org/10.1111/j.1749-771X.2012.01152.x
  • Rath, A., & Reena. (2022). Role of pudendal nerve block for prevention of catheter-related bladder discomfort in male pediatric patients undergoing hypospadias surgery: A prospective randomized control study. Ain-Shams Journal of Anesthesiology, 14, 40. https://doi.org/10.1186/s42077-022-00233-2
  • Savas EH, Demir AS, Semerci R, Karadag A. Effect of virtual reality on pain during burn dressing in children: A systematic review and meta-analysis of randomized controlled trials. J Pediatr Nurs. 2023 Nov-Dec;73:e364-e371. doi: 10.1016/j.pedn.2023.10.002. Epub 2023 Oct 7. PubMed 37806856 ↗
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Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2025 to primary completion in Mar 2026, 2 months.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 2 months is below that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2026
First posted
Aug 7, 2026
StartActual
Dec 5, 2025
Primary completionActual
Mar 1, 2026
CompletionActual
Jun 30, 2026
Last update
Aug 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07752680
Responsible party
aysel kokcudogan (Ph.D., Asst. Prof., Istanbul Medipol University Hospital) — Principal investigator
First posted
Aug 7, 2026
Start date
Dec 5, 2025
Primary completion
Mar 1, 2026
Completion
Jun 30, 2026
Last update
Aug 7, 2026

Study contacts

Aysel Kokcu Dogan
study director · Faculty Member

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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