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OpenTrials
Completed

NCT Number: NCT06235723

Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic

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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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical School Hanover

Hanover, Lower Saxony, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • epilepsy
  • coronary artery disease
  • history of severe vertigo
  • obstacles to putting on and wearing VR glasses
  • lack of informed consent for study participation.

Treatment and study plan

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.

Primary outcomes

  1. Procedural Pain measured with Numeric Rating Scale (NRS; scale 0-10; higher score stating higher levels of pain)

    Time frame: pre-, peri-, post-interventional (before puncture when entering intervention room, during puncture and 5 minutes after puncture)

    Virtual Reality vs. Standard-of-Care

  2. Procedural Anxiety measured with modified Yale Preoperative Anxiety Scale (mYPAS-SF; scale 23-100; higher score stating higher levels of anxiety)

    Time frame: pre-, peri-interventional (before puncture when entering intervention room and during puncture)

    Virtual Reality vs. Standard-of-Care

  3. Procedural Distress measured with Behavioral Approach Avoidance Distress Scale (BAADS; scale 0-10; higher score stating higher levels of distress)

    Time frame: pre-, peri-interventional (before puncture when entering intervention room and during puncture)

    Virtual Reality vs. Standard-of-Care

Secondary outcomes

  1. Acceptance of VR in pediatric procedures (questionnaire using a 5-point-likert-scale)

    Time frame: post-interventional (immediately after the intervention)

    Parents and patients were given different statements

  2. Implementation factors for VR in pediatric outpatient clinics (qualitive questionnaire)

    Time frame: through study completion, ~ 1.5 years in total

    Involved staff were asked about experience/feedback

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic: a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 1, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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