NCT06235723Completed
Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic
Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 23 Dec 2023
- Start date
- 1 Jul 2021
- Primary completion date
- 20 Dec 2022
- Lead sponsor
- Hannover Medical School
- Diseases
- Childhood cancers
- NCT number
- NCT06235723
What you commit to
- Study type: Interventional
- Participants enrolled: 38
- From 1 Jul 2021 to the primary completion date, 20 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- epilepsy
- coronary artery disease
- history of severe vertigo
Other
- obstacles to putting on and wearing VR glasses
- lack of informed consent for study participation.
Who the study is looking for
- aged 6-18 years
- any sex
- port puncture or placement of a peripheral venous catheter in pediatric outpatient clinic
- hematological or oncological diagnosis
- informed consent
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical School Hanover Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.