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Visual and Auditory Distraction for the Relief of Pain and Anxiety

NCT07023692 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-06-17

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-20
Primary Completion
2028-12-31
Completion
2029-06-30

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07023692 on ClinicalTrials.gov