Urinary CatheterizationNCT07546305
Effect of Virtual Reality and Tablet-Based Distraction Techniques on Behavioral Distress in Children During Urinary Catheterization
A study testing Virtual Reality Distraction and Tablet-Based Distraction in people with Urinary Catheterization, run by nibras mohammed kadhim at 1 site in Iraq.
Trial summary
This randomized controlled trial will evaluate the effect of Virtual Reality (VR) and tablet-based distraction techniques on children's behavioral distress during urinary catheterization, compared with a control group receiving standard care. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Urinary Catheterization
- What is being tested?
- Virtual Reality Distraction and Tablet-Based Distraction
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIraq
- Study dates
- 30 May 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: Children aged 6 to 16 years.
- Procedure: Children undergoing urinary catheterization at the Children's Welfare Teaching Hospital.
- Cognitive Status: Children with normal cognitive development and the ability to follow instructions.
- Sensory Ability: Children with normal or corrected-to-normal vision and hearing.
- Consent: Obtaining written informed consent from the legal guardian and verbal assent from the child.
Who cannot join
- Medical History: History of epilepsy, seizures, or severe motion sickness (VR safety).
- Emergency Cases: Children requiring urgent/emergency catheterization.
- Disabilities: Children with intellectual disabilities or significant physical impairments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
Welfare Teaching Hospital
Baghdad
Child Protection Teaching Hospital, 9647723499901, nursing@conursing.uobaghdad.edu.iq
9647513261022
About this study
Official title: Effect of Virtual Reality and Tablet-Based Distraction Techniques on Behavioral Distress in Children During Urinary Catheterization: A Randomized Controlled Trial
This randomized controlled trial will evaluate the effect of Virtual Reality (VR) and tablet-based distraction techniques on children's behavioral distress during urinary catheterization, compared with a control group receiving standard care. Urinary catheterization is a painful and distressing procedure for children that requires effective non-pharmacological interventions to manage anxiety and pain. Participants will be randomly assigned to one of three groups: VR distraction, tablet-based distraction, or control. The findings of this study will provide evidence on the effectiveness of digital distraction methods in reducing behavioral distress and improving the overall experience for pediatric patients undergoing invasive procedures at specialized pediatric centers.
Read the detailed description
Urinary catheterization is a common yet highly stressful medical procedure in pediatric settings, often leading to significant behavioral distress, anxiety, and pain. High levels of distress can complicate the procedure and lead to negative psychological outcomes for the child. While traditional distraction methods exist, advanced technological approaches such as Virtual Reality (VR) and tablet-based games are gaining attention; however, more comparative evidence is needed regarding their efficacy during specific invasive procedures like catheterization.
This study will be conducted as a randomized controlled trial at the Children's Welfare Teaching Hospital within the Medical City Complex in Baghdad. A total of [Insert Number] children requiring urinary catheterization will be enrolled and randomly assigned to one of three groups:
Virtual Reality (VR) Group: Children will engage with immersive VR content using a headset during the procedure to provide a high level of sensory immersion.
Tablet-Based Group: Children will use interactive games or videos on a handheld tablet, representing a more common digital distraction tool.
Control Group: Children will receive routine procedural care or standard distraction as per the hospital's current protocols.
Data will be collected using standardized tools to measure behavioral distress, such as the Observational Scale of Behavioral Distress-Revised (OSBD-R). The study will compare the effects of these distraction methods on the level of distress exhibited by the children before, during, and after the procedure. Additionally, the study aims to provide clinical evidence that can be integrated into nursing practice at the Children's Welfare Teaching Hospital to enhance the quality of pediatric nursing care and reduce the psychological impact of invasive procedures.
- Conditions
- Urinary Catheterization
- Being tested
- Virtual Reality Distraction, Tablet-Based Distraction
- Keywords
- Virtual Reality, Tablet-Based Distraction, Pediatric Patients, Urinary Catheterization, Behavioral Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DistractionDevice
An immersive VR headset (e.g., Meta Quest or similar) displaying 3D animated content or interactive games specifically designed for pediatric distraction.
Tablet-Based DistractionDevice
A handheld tablet device (e.g., iPad or Android Tablet) providing two-dimensional interactive games or animated videos selected according to the child's preference.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Distraction Group | Experimental | Pediatric patients in this group will be provided with a Virtual Reality (VR) headset during the urinary catheterization procedure. They will engage with immersive, age-appropriate 3D content during procedure Receives: Device: Virtual Reality Distraction |
| Tablet-Based Distraction Group | Experimental | Pediatric patients in this group will use a handheld tablet device during the urinary catheterization procedure. Receives: Device: Tablet-Based Distraction |
| Control Group (Standard Care) | No intervention | Pediatric patients in this group will receive the standard nursing care and routine distraction protocols currently implemented at the Children's Welfare Teaching Hospital. No digital devices (VR or Tablets) will be introduced. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Behavioral Distress Level
Behavioral distress will be assessed using the Observational Scale of Behavioral Distress-Revised (OSBD-R), specifically focusing on 8 key behavioral categories (such as crying, screaming, physical restraint, and verbal resistance). Each behavior is weighted based on its intensity to provide a comprehensive distress score. Data will be collected across three procedural phases to evaluate the effectiveness of Virtual Reality and Tablet-based distraction compared to standard care. Lower total scores indicate a reduction in behavioral distress
Measured: Measurements recorded at three points: 2 minutes before (Baseline), during the procedure (2-5 minutes), and 2 minutes after completion (Recovery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start30 May 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Urinary CatheterizationStudies 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
- participants will be randomly assigned to one of three parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- nibras mohammed kadhim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, nibras mohammed kadhim, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546305
- Sponsor's protocol ID
- UoBaghdad_NMohammed_1204b
- Status last verified
- May 2026
- First submitted
- 15 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy. Due to the small sample size and the specific clinical setting (Child Protection Teaching Hospital), there is a risk that participants could be identified even after de-identification. This approach aligns with ethical standards for protecting vulnerable populations
Publications
Leroy S, et al. Physical and psychological impact of invasive procedures in pediatrics. J Pediatr Nurs. 2020;52:45-52.
Birnie KA, Ouellette C, Do Amaral T, Stinson JN. Procedural pain management for children: A systematic review and meta-analysis. Pain. 2018;159(11):2112-25.
Burns-Nader S, Edwards A, Iben S, Jones. Tablet-based distraction in the emergency department. Clin Pediatr. 2021; 60(4): 215-224.
Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
PubMed 29053848Lambert V, O'Sullivan C, Burke S, O'Toole S. Virtual reality vs tablet-based distraction for pediatric procedural distress: A randomized controlled trial. Pediatr Nurs J. 2024;50(2):112-20.
Aydin S, Arslan MT. The effect of virtual reality on pain and anxiety during urinary catheterization in children: a randomized controlled study. J Pediatr Urol. 2022;18(5):656.e1-656.e8.
1. Hadjiedj S, Annequin D, Gall O. Procedural pain in children: Prevention and treatment. Arch Pediatr. 2021;28(1):70-77. Available from: https://doi.org/10.1016/j.arcped.2020.11.001
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality and Tablet-Based Distraction Techniques on Behavioral Distress in Children During Urinary Catheterization: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07546305
- Acronym / sponsor ID
- UoBaghdad_NMohammed_1204b
- Conditions
- Urinary Catheterization
- Keywords
- Virtual Reality, Tablet-Based Distraction, Pediatric Patients, Urinary Catheterization, Behavioral Distress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- nibras mohammed kadhimUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 22 Apr 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.
This randomized controlled trial will evaluate the effect of Virtual Reality (VR) and tablet-based distraction techniques on children's behavioral distress during urinary catheterization, compared with a control group receiving standard care. Urinary catheterization is a painful and distressing procedure for children that requires effective non-pharmacological interventions to manage anxiety and pain. Participants will be randomly assigned to one of three groups: VR distraction, tablet-based distraction, or control. The findings of this study will provide evidence on the effectiveness of digital distraction methods in reducing behavioral distress and improving the overall experience for pediatric patients undergoing invasive procedures at specialized pediatric centers.
Detailed description
Urinary catheterization is a common yet highly stressful medical procedure in pediatric settings, often leading to significant behavioral distress, anxiety, and pain. High levels of distress can complicate the procedure and lead to negative psychological outcomes for the child. While traditional distraction methods exist, advanced technological approaches such as Virtual Reality (VR) and tablet-based games are gaining attention; however, more comparative evidence is needed regarding their efficacy during specific invasive procedures like catheterization.
This study will be conducted as a randomized controlled trial at the Children's Welfare Teaching Hospital within the Medical City Complex in Baghdad. A total of [Insert Number] children requiring urinary catheterization will be enrolled and randomly assigned to one of three groups:
Virtual Reality (VR) Group: Children will engage with immersive VR content using a headset during the procedure to provide a high level of sensory immersion.
Tablet-Based Group: Children will use interactive games or videos on a handheld tablet, representing a more common digital distraction tool.
Control Group: Children will receive routine procedural care or standard distraction as per the hospital's current protocols.
Data will be collected using standardized tools to measure behavioral distress, such as the Observational Scale of Behavioral Distress-Revised (OSBD-R). The study will compare the effects of these distraction methods on the level of distress exhibited by the children before, during, and after the procedure. Additionally, the study aims to provide clinical evidence that can be integrated into nursing practice at the Children's Welfare Teaching Hospital to enhance the quality of pediatric nursing care and reduce the psychological impact of invasive procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- participants will be randomly assigned to one of three parallel groups
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Distraction Group | Experimental | Device: Virtual Reality DistractionPediatric patients in this group will be provided with a Virtual Reality (VR) headset during the urinary catheterization procedure. They will engage with immersive, age-appropriate 3D content during procedure |
| Tablet-Based Distraction Group | Experimental | Device: Tablet-Based DistractionPediatric patients in this group will use a handheld tablet device during the urinary catheterization procedure. |
| Control Group (Standard Care) | No intervention | –Pediatric patients in this group will receive the standard nursing care and routine distraction protocols currently implemented at the Children's Welfare Teaching Hospital. No digital devices (VR or Tablets) will be introduced. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age: Children aged 6 to 16 years.
- Procedure: Children undergoing urinary catheterization at the Children's Welfare Teaching Hospital.
- Cognitive Status: Children with normal cognitive development and the ability to follow instructions.
- Sensory Ability: Children with normal or corrected-to-normal vision and hearing.
- Consent: Obtaining written informed consent from the legal guardian and verbal assent from the child.
Key exclusion criteria (3 listed)
- Medical History: History of epilepsy, seizures, or severe motion sickness (VR safety).
- Emergency Cases: Children requiring urgent/emergency catheterization.
- Disabilities: Children with intellectual disabilities or significant physical impairments.
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 DistractionAn immersive VR headset (e.g., Meta Quest or similar) displaying 3D animated content or interactive games specifically designed for pediatric distraction. | Device | Virtual Reality Distraction Group |
| Tablet-Based DistractionA handheld tablet device (e.g., iPad or Android Tablet) providing two-dimensional interactive games or animated videos selected according to the child's preference. | Device | Tablet-Based Distraction Group |
Primary outcome
Children's Behavioral Distress Level
Time frame: Measurements recorded at three points: 2 minutes before (Baseline), during the procedure (2-5 minutes), and 2 minutes after completion (Recovery).
Behavioral distress will be assessed using the Observational Scale of Behavioral Distress-Revised (OSBD-R), specifically focusing on 8 key behavioral categories (such as crying, screaming, physical restraint, and verbal resistance). Each behavior is weighted based on its intensity to provide a comprehensive distress score. Data will be collected across three procedural phases to evaluate the effectiveness of Virtual Reality and Tablet-based distraction compared to standard care. Lower total scores indicate a reduction in behavioral distress
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- BackgroundLeroy S, et al. Physical and psychological impact of invasive procedures in pediatrics. J Pediatr Nurs. 2020;52:45-52.
- BackgroundBirnie KA, Ouellette C, Do Amaral T, Stinson JN. Procedural pain management for children: A systematic review and meta-analysis. Pain. 2018;159(11):2112-25.
- BackgroundBurns-Nader S, Edwards A, Iben S, Jones. Tablet-based distraction in the emergency department. Clin Pediatr. 2021; 60(4): 215-224.
- Background: PubMed 29053848Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
- BackgroundLambert V, O'Sullivan C, Burke S, O'Toole S. Virtual reality vs tablet-based distraction for pediatric procedural distress: A randomized controlled trial. Pediatr Nurs J. 2024;50(2):112-20.
- BackgroundAydin S, Arslan MT. The effect of virtual reality on pain and anxiety during urinary catheterization in children: a randomized controlled study. J Pediatr Urol. 2022;18(5):656.e1-656.e8.
- Background1. Hadjiedj S, Annequin D, Gall O. Procedural pain in children: Prevention and treatment. Arch Pediatr. 2021;28(1):70-77. Available from: https://doi.org/10.1016/j.arcped.2020.11.001
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy. Due to the small sample size and the specific clinical setting (Child Protection Teaching Hospital), there is a risk that participants could be identified even after de-identification. This approach aligns with ethical standards for protecting vulnerable populations
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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.
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 Distraction and Tablet-Based Distraction in people with Urinary Catheterization, run by nibras mohammed kadhim at 1 site in Iraq.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 8 May 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nibras Mohammed Kadhim, PHD (9647728580462, nebras.mohammed1204b@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Behavioral Distress Level (time frame: Measurements recorded at three points: 2 minutes before (Baseline), during the procedure (2-5 minutes), and 2 minutes after completion (Recovery).). 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 NCT07546305, which also lists 7 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 8 May 2026.