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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Gaming | Experimental |
| |
| Nitrous Oxide | Active Comparator | Standard procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Directly after surgery (up to 20 minutes) |
| Fun two weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cordula Scherer | Contact | +41 31 632 92 38 | cordula.scherer@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Cordula Scherer, Dr.med | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital Bern | Recruiting | Bern | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39833849 | Derived | 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. |
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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.
Study Protocol: before end of enrolling Data Set and Statistical code: from three months following the final enrollment
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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| Nitrous oxide | Drug | Standard procedure |
|
| Before (up to 3 minutes) and directly after the surgery (up to 3 minutes) |
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)
| 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) | 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) | 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) | During the surgery (estimated to be 3 to 25 minutes) |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |