Visual and Auditory Distraction for the Relief of Pain and Anxiety

NCT07023692 | Enrolling By Invitation

• 1 other identifier: 2024-02133-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Bone Marrow Aspiration; Pain; Anxiety; Hematologic Diseases; Hematologic Disorders; Visual Distraction; Auditory Distraction

Keywords

pain perception; anxiety; nociceptive response; relief of pain; relief of anxiety; visual distraction; auditory distraction

Outcome Measures

Primary Outcomes (5)

• Nociceptive response

  Objective markers measuring the level of pain, nociceptive response, monitored by using the the NOL technique, which presents an indexed value between 0 and 100 (i.e. units on a scale), where a higher score means worse outcome, i.e., higher nociceptive response.

  Periprocedural

• Nociceptive response

  Objective markers measuring the level of pain, nociceptive response, monitored by using the the MedStorm PainSensor technique, which presents an indexed value between 0 and 10 (i.e. units on a scale), where a higher score means worse outcome, i.e., higher nociceptive response.

  Periprocedural

• Self-reported subjective health

  Questionnaires will be given to the study participants with validated self-reported instrument Perceived Health: RAND-36 - RAND Corporation (Research and Development), reporting a score, 0 - 100 points on a scale, where a higher score means better outcome, i.e. the better health.

  Immediately after the bone marrow examination - Periprocedural

• Self-reported subjective pain

  Questionnaires will be given to the study participants with the validated self-reported instrument Self-reported Pain: NRS - Numerical Rating Scale, where pain is indicated on a scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.

  Immediately after the bone marrow examination - Periprocedural

• Self-reported subjective anxiety

  Questionnaires will be given to the study participants with the validated self-reported instrument Self-reported Anxiety: STAI - State-Trait Anxiety Inventory. A score will be reported on a scale, where the scores range between 20-80 points, where a higher score means worse outcome, i.e., higher scores indicating higher levels of anxiety.

  Immediately after the bone marrow examination - Periprocedural

Secondary Outcomes (1)

• Heart rate

  Periprocedural

Study Arms (2)

Intervention group

EXPERIMENTAL

Distraction with VR headsets during bone marrow examinations

Behavioral: Distraction with VR (Virtual Reality) headsets

Control group

NO INTERVENTION

Bone marrow examinations according to standard procedure

Interventions

Distraction with VR (Virtual Reality) headsets BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years) patients
• Adult (≥18 years) healthy volunteers without a hematological diagnosis undergoing bone marrow examination (aspiration and/or biopsy) at the Hematology Out-Patient Care Unit at SUS in Lund, Sweden.

You may not qualify if:

• Individuals who cannot understand information and instructions
• Pregnant women
• Persons with skin injuries at the bone marrow examination site
• Those unable to lie on their side
• hearing and/or severe vision impairment
• those prone to motion sickness
• participation in the study during a previous bone marrow examination

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

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

Lund, Skåne County, Se-221 85, Sweden

Location

Related Publications (24)

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Related Links

• We have extensive clinical and research networks both nationally and internationally, including groups from Lund University and Gothenburg University with extensive knowledge and experience in pain management.

MeSH Terms

Conditions

Pain; Anxiety Disorders; Hematologic Diseases

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: June 17, 2025
• Study Start: October 20, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: June 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)