Visual and Auditory Distraction for the Relief of Pain and Anxiety

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Nociceptive response — Periprocedural
  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.
• Nociceptive response — Periprocedural
  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.
• Self-reported subjective health — Immediately after the bone marrow examination - Periprocedural
  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.
• Self-reported subjective pain — Immediately after the bone marrow examination - Periprocedural
  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.
• Self-reported subjective anxiety — Immediately after the bone marrow examination - Periprocedural
  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.

Trial sites (1)

More Region Skane trials in Sweden

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