Virtual Reality Games in Pediatric Surgery

NCT ID: NCT05510141

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-24

Study Completion Date

2024-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Analgesia Surgical Procedure, Unspecified Immersion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual Reality Gaming

Group Type EXPERIMENTAL

Virtual reality gaming

Intervention Type OTHER

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

Nitrous Oxide

Standard procedure

Group Type ACTIVE_COMPARATOR

Nitrous oxide

Intervention Type DRUG

Standard procedure

Interventions

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Virtual reality gaming

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

Intervention Type OTHER

Nitrous oxide

Standard procedure

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Cordula Scherer

Dr.med

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cordula Scherer, Dr.med

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

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Inselspital Bern

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Cordula Scherer

Role: CONTACT

+41 31 632 92 38

Facility Contacts

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Cordula Scherer, Dr.med

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39833849 (View on PubMed)

Other Identifiers

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2020-01446

Identifier Type: -

Identifier Source: org_study_id

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