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ENROLLING BY INVITATION
NCT07023692
NA

Visual and Auditory Distraction for the Relief of Pain and Anxiety

Sponsor: Region Skane

View on ClinicalTrials.gov

Summary

Bone marrow (BM) examinations are performed in diagnostic workup of malignancies, in particular hematological diseases, and are frequently associated with significant pain, distress, and anxiety. Analgesic and sedative medications are given to alleviate discomfort. The aim of this project is to study the effects of visual and auditory distraction on pain and anxiety during BM examinations. The project includes two baseline studies assessing pain perception, anxiety, and nociceptive response in patients and healthy volunteers undergoing BM examinations, and two randomized controlled trials evaluating the efficacy of VR distraction in reducing pain perception, anxiety, and nociceptive response. The intervention groups will use VR headsets, while control groups will follow standard procedure. Data collection include measurements of skin conductance, pulse, validated questionnaires and qualitative interviews. The project is strongly anchored in clinical practices and is a collaboration between Skåne University Hospital and Lund University, Sweden. The project group consists of three experts with relevant clinical and research competences. The project is ongoing, data collection will be finalized in 2028, and analyses and publications in 2027-2029. If distraction with VR results in less painful examinations and shows to be feasible in clinical praxis, the findings may contribute to development of new guidelines for pain management in BM-examinations and other painful medical procedures.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2024-10-20

Completion Date

2029-06-30

Last Updated

2025-06-17

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Distraction with VR (Virtual Reality) headsets

VR headsets will be fitted and applied in consultation with the study participants. Distraction material will be selected from a range of options based on the participant's preferences, such as watching/listening to a story, an experience of being in nature, or mindfulness. When applying the VR headsets, care will be taken to ensure no light leaks into the eyes and that the headband and headphones are not perceived as too tight. This is especially important in terms of the risk for motion sickness (cyber sickness). The VR headsets will then be used throughout the examination procedure and removed once the bandage has been applied.

Locations (1)

Hematology Out-Patient Care Unit , Department of hematology, oncology and radian physics, Skåne University Hospital (SUS) in Lund, Sweden

Lund, Skåne County, Sweden