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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medical School Hanover
Coordinator of this site? Confirm its status
HanoverGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.