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Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain reduction by virtual reality (VR) during port and vein punctures is well studied. This study investigates peri-interventional reduction of pain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric oncology outpatient clinic.
In a randomized, controlled cross-over design, patients aged 6-18 years experience potentially painful interventions accompanied by VR. All patients included in the study underwent port puncture or peripheral venous puncture in two observations : SOC (A) and VR (B) in a randomized order. Observational instruments include Numeral Rating Scale (NRS), Faces Pain Scale revised (FPS-r), Behavioral Approach Avoidance Distress Scale (BAADS), modified Yale Preoperative Anxiety Scale (mYPAS-SF). In addition, parents and staff are interviewed. Specific conditions for VR in an outpatient clinic setting are being discussed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOC (A) | No Intervention | SOC = Standard-of-Care | |
| VR (B) | Experimental | VR = Virtual Reality |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | Virtual Reality was used before and during punctures. For every observation patients underwent either port puncture or peripheral venous puncture. One examination was carried out according to the Standard-of-Care. The other one was carried out with the additional use of VR. Participants watched a passive distraction video. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Pain measured with Numeric Rating Scale (NRS; scale 0-10; higher score stating higher levels of pain) | Virtual Reality vs. Standard-of-Care | pre-, peri-, post-interventional (before puncture when entering intervention room, during puncture and 5 minutes after puncture) |
| Procedural Anxiety measured with modified Yale Preoperative Anxiety Scale (mYPAS-SF; scale 23-100; higher score stating higher levels of anxiety) | Virtual Reality vs. Standard-of-Care | pre-, peri-interventional (before puncture when entering intervention room and during puncture) |
| Procedural Distress measured with Behavioral Approach Avoidance Distress Scale (BAADS; scale 0-10; higher score stating higher levels of distress) | Virtual Reality vs. Standard-of-Care | pre-, peri-interventional (before puncture when entering intervention room and during puncture) |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of VR in pediatric procedures (questionnaire using a 5-point-likert-scale) | Parents and patients were given different statements | post-interventional (immediately after the intervention) |
| Implementation factors for VR in pediatric outpatient clinics (qualitive questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Urs Mücke, Dr. | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical School Hanover | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39097718 | Derived | Reitze A, Voigt M, Klawonn F, Dusch M, Grigull L, Mucke U. Impact of virtual reality on peri-interventional pain, anxiety and distress in a pediatric oncology outpatient clinic: a randomized controlled trial. BMC Pediatr. 2024 Aug 3;24(1):501. doi: 10.1186/s12887-024-04952-3. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
Involved staff were asked about experience/feedback |
| through study completion, ~ 1.5 years in total |