PainNCT07752680
Virtual Reality Intervention in Children After Hypospadias Surgery
A study testing Virtual reality headset and routine clinical practice in people with Pain and Comfort, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 6 to 12 years, men only
- Conditions the study is for
- Pain, Comfort, Psychosocial Symptoms
- What is being tested?
- Virtual reality headset and routine clinical practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Headset Use on Pain, Comfort, and Psychosocial Symptoms in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial.
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.
- Conditions
- Pain, Comfort, Psychosocial Symptoms
- Being tested
- Virtual reality headset, routine clinical practice
- Keywords
- Pain, Hypospadias, Comfort, Psychosocial symptoms, Virtual reality headset
- Medical subject headings
- Pain, Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetDevice
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.
routine clinical practiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | routine clinical practice Receives: Other: routine clinical practice |
| intervention group | Experimental | playing a 15-minute game through virtual reality glasses Receives: Device: Virtual reality headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after surgery/before and after application/2 times a day/10-15 minutes
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.
Measured: 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.
Measured: 1 hour after surgery/before and after application/2 times a day/10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start5 Dec 2025
- Primary completion1 Mar 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (55)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aysel kokcudogan, Istanbul Medipol University Hospital
- Investigators
- Aysel Kokcu Dogan, Study director, Faculty Member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752680
- Sponsor's protocol ID
- E10840098-202.3.02-170
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Althumairi A, Sahwan M, Alsaleh S, Alabduljobar Z, Aljabri D. Virtual Reality: Is It Helping Children Cope with Fear and Pain During Vaccination? J Multidiscip Healthc. 2021 Sep 21;14:2625-2632. doi: 10.2147/JMDH.S327349. eCollection 2021.
PubMed 34584419Bhat A. General considerations in hypospadias surgery. Indian J Urol. 2008 Apr;24(2):188-94. doi: 10.4103/0970-1591.40614.
PubMed 19468396Buyuk ET, Odabasoglu E, Uzsen H, Koyun M. The effect of virtual reality on Children's anxiety, fear, and pain levels before circumcision. J Pediatr Urol. 2021 Aug;17(4):567.e1-567.e8. doi: 10.1016/j.jpurol.2021.04.008. Epub 2021 Apr 21.
PubMed 34006462Chen SR, Yamaji N, Wang CH, Pan CH, Wu YL. Effects of Virtual Reality on Pain and Anxiety During Children's Circumcision: A Systematic Review and Meta-Analysis. Pain Manag Nurs. 2024 Dec;25(6):652-658. doi: 10.1016/j.pmn.2024.06.007. Epub 2024 Jul 10.
PubMed 38991908Comparcini D, Simonetti V, Galli F, Saltarella I, Altamura C, Tomietto M, Desaphy JF, Cicolini G. Immersive and Non-Immersive Virtual Reality for Pain and Anxiety Management in Pediatric Patients with Hematological or Solid Cancer: A Systematic Review. Cancers (Basel). 2023 Feb 3;15(3):985. doi: 10.3390/cancers15030985.
PubMed 36765945European Association of Urology. (2026). Paediatric urology guidelines: Hypospadias. EAU Guidelines Office. Retrieved July 3, 2026, from https://uroweb.org/guidelines/paediatric-urology/chapter/hypospadias
Fauzan R, Wahyudi I, Reinaldi Situmorang G, Rodjani A, Angga Risky Raharja P. Psychological Outcomes After Hypospadias Repair: Does Age at Surgery Matter? A Systematic Review. Cureus. 2026 May 31;18(5):e109964. doi: 10.7759/cureus.109964. eCollection 2026 May.
PubMed 42338833Fortier MA, Del Rosario AM, Rosenbaum A, Kain ZN. Beyond pain: predictors of postoperative maladaptive behavior change in children. Paediatr Anaesth. 2010 May;20(5):445-53. doi: 10.1111/j.1460-9592.2010.03281.x. Epub 2010 Feb 23.
PubMed 20199608Gültekin, M., (2019). Evaluation of the effect of distraction methods used in blood sampling on pain and anxiety in children. (Thesis No. 565770) [Master's Thesis, Balıkesir University] YÖK National Thesis Center.
Hayaran N, Kaushik P, Yadav S, Hage A. A Prospective Observational Study Analyzing the Analgesic Efficacy of Caudal Block and Nerve Stimulator-Guided Pudendal Nerve Block in Children Undergoing Hypospadias Repair. Cureus. 2023 Sep 4;15(9):e44649. doi: 10.7759/cureus.44649. eCollection 2023 Sep.
PubMed 37671076Hayashi Y, Kojima Y. Current concepts in hypospadias surgery. Int J Urol. 2008 Aug;15(8):651-64. doi: 10.1111/j.1442-2042.2008.02081.x. Epub 2008 Jun 3.
PubMed 18522675Hess CW, Rosenbloom BN, Mesaroli G, Lopez C, Ngo N, Cohen E, Ouellette C, Gold JI, Logan D, Simons LE, Stinson JN. Extended Reality (XR) in Pediatric Acute and Chronic Pain: Systematic Review and Evidence Gap Map. JMIR Pediatr Parent. 2025 Apr 7;8:e63854. doi: 10.2196/63854.
PubMed 40194270Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666.
PubMed 30362982İnal, S., & Canbulat, N. (2015). Use of distraction techniques in procedural pain management in children. Journal of Health Sciences in Nursing (HSP), 2(3), 372-378.
Kahraman Kılbaş, E. P., & Cevahir, F. (2023). Sampling Selection and Power Analysis in Scientific Research. Journal of Biotechnology and Strategic Health Research, 7(1), 1-8. https://doi.org/10.34084/bshr.1217279
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Headset Use on Pain, Comfort, and Psychosocial Symptoms in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07752680
- Acronym / sponsor ID
- E10840098-202.3.02-170
- Conditions
- Pain, Comfort, Psychosocial Symptoms
- Keywords
- Pain, Hypospadias, Comfort, Psychosocial symptoms, Virtual reality headset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Other: routine clinical practiceroutine clinical practice |
| intervention group | Experimental | Device: Virtual reality headsetplaying a 15-minute game through virtual reality glasses |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality headsetOne 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. | Device | intervention group |
| routine clinical practiceChildren 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. | Other | control group |
Primary outcome
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.
1 secondary outcome
Psychosocial symptom assessment scale for hospitalized children
Time frame: 1 hour after surgery/before and after application/2 times a day/10-15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 34584419Althumairi A, Sahwan M, Alsaleh S, Alabduljobar Z, Aljabri D. Virtual Reality: Is It Helping Children Cope with Fear and Pain During Vaccination? J Multidiscip Healthc. 2021 Sep 21;14:2625-2632. doi: 10.2147/JMDH.S327349. eCollection 2021.
- Background: PubMed 19468396Bhat A. General considerations in hypospadias surgery. Indian J Urol. 2008 Apr;24(2):188-94. doi: 10.4103/0970-1591.40614.
- Background: PubMed 34006462Buyuk ET, Odabasoglu E, Uzsen H, Koyun M. The effect of virtual reality on Children's anxiety, fear, and pain levels before circumcision. J Pediatr Urol. 2021 Aug;17(4):567.e1-567.e8. doi: 10.1016/j.jpurol.2021.04.008. Epub 2021 Apr 21.
- Background: PubMed 38991908Chen SR, Yamaji N, Wang CH, Pan CH, Wu YL. Effects of Virtual Reality on Pain and Anxiety During Children's Circumcision: A Systematic Review and Meta-Analysis. Pain Manag Nurs. 2024 Dec;25(6):652-658. doi: 10.1016/j.pmn.2024.06.007. Epub 2024 Jul 10.
- Background: PubMed 36765945Comparcini D, Simonetti V, Galli F, Saltarella I, Altamura C, Tomietto M, Desaphy JF, Cicolini G. Immersive and Non-Immersive Virtual Reality for Pain and Anxiety Management in Pediatric Patients with Hematological or Solid Cancer: A Systematic Review. Cancers (Basel). 2023 Feb 3;15(3):985. doi: 10.3390/cancers15030985.
- BackgroundEuropean Association of Urology. (2026). Paediatric urology guidelines: Hypospadias. EAU Guidelines Office. Retrieved July 3, 2026, from https://uroweb.org/guidelines/paediatric-urology/chapter/hypospadias
- Background: PubMed 42338833Fauzan R, Wahyudi I, Reinaldi Situmorang G, Rodjani A, Angga Risky Raharja P. Psychological Outcomes After Hypospadias Repair: Does Age at Surgery Matter? A Systematic Review. Cureus. 2026 May 31;18(5):e109964. doi: 10.7759/cureus.109964. eCollection 2026 May.
- Background: PubMed 20199608Fortier MA, Del Rosario AM, Rosenbaum A, Kain ZN. Beyond pain: predictors of postoperative maladaptive behavior change in children. Paediatr Anaesth. 2010 May;20(5):445-53. doi: 10.1111/j.1460-9592.2010.03281.x. Epub 2010 Feb 23.
- BackgroundGültekin, M., (2019). Evaluation of the effect of distraction methods used in blood sampling on pain and anxiety in children. (Thesis No. 565770) [Master's Thesis, Balıkesir University] YÖK National Thesis Center.
- Background: PubMed 37671076Hayaran N, Kaushik P, Yadav S, Hage A. A Prospective Observational Study Analyzing the Analgesic Efficacy of Caudal Block and Nerve Stimulator-Guided Pudendal Nerve Block in Children Undergoing Hypospadias Repair. Cureus. 2023 Sep 4;15(9):e44649. doi: 10.7759/cureus.44649. eCollection 2023 Sep.
- Background: PubMed 18522675Hayashi Y, Kojima Y. Current concepts in hypospadias surgery. Int J Urol. 2008 Aug;15(8):651-64. doi: 10.1111/j.1442-2042.2008.02081.x. Epub 2008 Jun 3.
- Background: PubMed 40194270Hess CW, Rosenbloom BN, Mesaroli G, Lopez C, Ngo N, Cohen E, Ouellette C, Gold JI, Logan D, Simons LE, Stinson JN. Extended Reality (XR) in Pediatric Acute and Chronic Pain: Systematic Review and Evidence Gap Map. JMIR Pediatr Parent. 2025 Apr 7;8:e63854. doi: 10.2196/63854.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysel Kokcu Dogan study director
Faculty Member
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality headset and routine clinical practice in people with Pain and Comfort, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wong-baker faces scale (time frame: 1 hour after surgery/before and after application/2 times a day/10-15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07752680, which also lists 55 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.