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

NCT ID: NCT06235723

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-12-20

Brief Summary

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.

Conditions

Pediatric Cancer; Procedural Anxiety; Procedural Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SOC (A)

SOC = Standard-of-Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

VR (B)

VR = Virtual Reality

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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.

Interventions

Virtual Reality

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urs Mücke, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

Medical School Hanover

Hanover, Lower Saxony, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 39097718 (View on PubMed)

Other Identifiers

VirtualReality2023

Identifier Type: -

Identifier Source: org_study_id