Virtual Reality Games in Pediatric Surgery

NCT05510141 | Recruiting

• 1 other identifier: 2020-01446
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized controlled trial reporting the pain levels and pain control/reduction of children at the age of 6-15 undergoing surgical procedures by using virtual reality gaming (VR) compared to nitrous oxide. Therefore, 50 patients in each treatment group are recruited, resulting in 100 children altogether. The pain levels and pain control/reduction is measured by the standard anesthesia protocol normally used when nitrous oxide is applied and questionnaires that are administered to the patients at baseline and two weeks after surgery including both the primary and secondary outcome.

Conditions

Analgesia; Surgical Procedure, Unspecified; Immersion

Outcome Measures

Primary Outcomes (6)

• Visual face scale of Bieri score directly after surgery

  Pain scale to measure pain reduction for children at the age 6-9, the score results in a pain score from 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)

  Directly after surgery (up to 20 minutes)

• Visual analogue scale (VAS) directly after surgery

  Pain scale to measure pain reduction for children at the age 11-15, the score results in a pain score from 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)

  Directly after surgery (up to 20 minutes)

• Visual face scale of Bieri score two weeks after surgery

  Pain scale to measure pain reduction for children at the age 6-9, the score results in a pain score from 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)

  Two weeks after surgery

• Visual analogue scale (VAS) two weeks after surgery

  Pain scale to measure pain reduction for children at the age 11-15, the score results in a pain score from 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)

  Two weeks after surgery

• Change in objective pain reaction measured by heart frequencies

  Elevation of the heart rate indicates pain

  During the procedure, estimated to be in average 15-20min

• Change in objective pain reaction measured by blood pressure

  Elevation of blood pressure indicates pain, we measure the difference between the two measures

  Before (up to 3 minutes) and directly after the surgery (up to 3 minutes)

Secondary Outcomes (5)

• Fun directly after surgery

  Directly after surgery (up to 20 minutes)

• Fun two weeks after surgery

  Two weeks after surgery

• Patient satisfaction directly after surgery

  Directly after surgery (up to 20 minutes)

• Patient satisfaction two weeks after surgery

  Two weeks after surgery

• Time limit of virtual reality gaming

  During the surgery (estimated to be 3 to 25 minutes)

Study Arms (2)

Virtual Reality Gaming

EXPERIMENTAL

Other: Virtual reality gaming

Nitrous Oxide

ACTIVE COMPARATOR

Standard procedure

Drug: Nitrous oxide

Interventions

Virtual reality gaming OTHER

Instead of nitrous oxide, which is the standard procedure, virtual reality gaming is applied to reach pain reduction in minor surgery procedures

Virtual Reality Gaming

Nitrous oxide DRUG

Standard procedure

Nitrous Oxide

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Indication to undergo an elective minor surgical procedure (removal of percutaneous osteosynthesis or pin material or dressing change)
• Written informed consent by parents
• Written informed consent by patient if patient is 14 or 15 years old

You may not qualify if:

• Inability to understand the VR-program
• Inability to fill in the questionnaire because of language deficiencies
• Neurologic disorders
• Respiratory tract infections
• Intolerance of the VR headset or VR gaming procedure

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Bern

Bern, Switzerland

RECRUITING

Related Publications (1)

• Scherer C, Lanz LA, Liebs TR, Kaiser N, Zindel M, Berger SM. A randomized controlled trial comparing immersive virtual reality games versus nitrous oxide for pain reduction in common outpatient procedures in pediatric surgery. Trials. 2025 Jan 20;26(1):21. doi: 10.1186/s13063-025-08718-9.

  PMID: 39833849 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• Cordula Scherer, Dr.med

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cordula Scherer

CONTACT

+41 31 632 92 38; cordula.scherer@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 22, 2022
• Study Start: August 24, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Study Protocol: before end of enrolling Data Set and Statistical code: from three months following the final enrollment

Locations

CH (1)