AnalgesiaNCT05510141
Virtual Reality Games in Pediatric Surgery
A study testing Virtual reality gaming and Nitrous oxide in people with Analgesia and Surgical Procedure, Unspecified, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Analgesia, Surgical Procedure, Unspecified, Immersion
- What is being tested?
- Virtual reality gaming and Nitrous oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Aug 2022to 1 Oct 2024
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital Bern
Bern
Cordula Scherer, Dr.med
About this study
Official title: A Randomized Controlled Trial Comparing Virtual Reality Games Versus Nitrous Oxide for Pain Reduction in Common Outpatient Procedures in Pediatric Surgery
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
- Being tested
- Virtual reality gaming, Nitrous oxide
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality gamingOther
Instead of nitrous oxide, which is the standard procedure, virtual reality gaming is applied to reach pain reduction in minor surgery procedures
Nitrous oxideDrug
Standard procedure
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Gaming | Experimental | Not described Receives: Other: Virtual reality gaming |
| Nitrous Oxide | Active comparator | Standard procedure Receives: Drug: Nitrous oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Two weeks after surgery
Change in objective pain reaction measured by heart frequencies
Elevation of the heart rate indicates pain
Measured: 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
Measured: Before (up to 3 minutes) and directly after the surgery (up to 3 minutes)
Secondary outcomes (5)
Fun directly after surgery
Did the patient have fun during the procedures, measured by questionnaires with a Likert Scale from 1 to 6 (1= no fun, 6= maximum of fun)
Measured: Directly after surgery (up to 20 minutes)
Fun two weeks after surgery
Did the patient have fun during the procedures, measured by questionnaires with a Likert Scale from 1 to 6 (1= no fun, 6= maximum of fun)
Measured: Two weeks after surgery
Patient satisfaction directly after surgery
The patient is asked in the questionnaires if he/she woud undergo the procedures again with a Likert Scale from 1 to 6 (1= would absolutely not do it again, 6= would absolutely do it again)
Measured: Directly after surgery (up to 20 minutes)
Patient satisfaction two weeks after surgery
The patient is asked in the questionnaires if he/she woud undergo the procedures again with a Likert Scale from 1 to 6 (1= would absolutely not do it again, 6= would absolutely do it again)
Measured: Two weeks after surgery
Time limit of virtual reality gaming
The time is measured while nitrous oxide or virtual reality gaming is administered. The investigators evaluate if there is a time limit for virtual reality gaming, where they have to stop the intervention (comparable to the time limit of nitrous oxide application of 20 min)
Measured: During the surgery (estimated to be 3 to 25 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start24 Aug 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cordula Scherer, Insel Gruppe AG, University Hospital Bern
- Investigators
- Cordula Scherer, Dr.med, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510141
- Sponsor's protocol ID
- 2020-01446
- Status last verified
- Apr 2024
- First submitted
- 16 Aug 2022
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final trial data set and statistical code will be made available from the corresponding author from three months following the final enrollment of patients within reasonable request, and will be published as mentioned in the ethical approvement. We plan to publish the study protocol in a peer-reviewed journal before end of enrolling.
Publications
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.
PubMed 39833849
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Virtual Reality Games Versus Nitrous Oxide for Pain Reduction in Common Outpatient Procedures in Pediatric Surgery
- ClinicalTrials.gov ID
- NCT05510141
- Acronym / sponsor ID
- 2020-01446
- Conditions
- Analgesia, Surgical Procedure, Unspecified, Immersion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 22 Aug 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Gaming | Experimental | Other: Virtual reality gaming |
| Nitrous Oxide | Active comparator | Drug: Nitrous oxideStandard procedure |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 gamingInstead of nitrous oxide, which is the standard procedure, virtual reality gaming is applied to reach pain reduction in minor surgery procedures | Other | Virtual Reality Gaming |
| Nitrous oxideStandard procedure | Drug | Nitrous Oxide |
Primary outcome
Visual face scale of Bieri score directly after surgery
Time frame: Directly after surgery (up to 20 minutes)
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)
Visual analogue scale (VAS) directly after surgery
Time frame: Directly after surgery (up to 20 minutes)
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)
Visual face scale of Bieri score two weeks after surgery
Time frame: 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)
Visual analogue scale (VAS) two weeks after surgery
Time frame: 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)
Change in objective pain reaction measured by heart frequencies
Time frame: During the procedure, estimated to be in average 15-20min
Elevation of the heart rate indicates pain
Change in objective pain reaction measured by blood pressure
Time frame: Before (up to 3 minutes) and directly after the surgery (up to 3 minutes)
Elevation of blood pressure indicates pain, we measure the difference between the two measures
5 secondary outcomes
Fun directly after surgery
Time frame: Directly after surgery (up to 20 minutes)
Fun two weeks after surgery
Time frame: Two weeks after surgery
Patient satisfaction directly after surgery
Time frame: Directly after surgery (up to 20 minutes)
Patient satisfaction two weeks after surgery
Time frame: Two weeks after surgery
Time limit of virtual reality gaming
Time frame: During the surgery (estimated to be 3 to 25 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 39833849Scherer 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.
- Individual participant dataSharing planned: Yes. The final trial data set and statistical code will be made available from the corresponding author from three months following the final enrollment of patients within reasonable request, and will be published as mentioned in the ethical approvement. We plan to publish the study protocol in a peer-reviewed journal before end of enrolling.
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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.
Cordula Scherer, Dr.med principal investigator
Insel Gruppe AG, University Hospital Bern
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 gaming and Nitrous oxide in people with Analgesia and Surgical Procedure, Unspecified, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cordula Scherer (+41 31 632 92 38, cordula.scherer@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual face scale of Bieri score directly after surgery (time frame: Directly after surgery (up to 20 minutes)). The study lists 6 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 NCT05510141, which also lists 1 linked publication.
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 11 Apr 2024.