Visual and Auditory Distraction for the Relief of Pain and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Region Skane
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Nociceptive response
研究概览
简要总结
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.
详细描述
Purpose and aims: The overall aim of this project is to study the effect of visual and auditory distraction as a relief for pain and anxiety in adults undergoing bone marrow aspiration and/or biopsy. The goal is to increase knowledge about pain and pain relief during bone marrow procedures, as well as to explore whether there is a difference in pain responses and experiences of health, anxiety, and pain between patients and healthy volunteers. Additionally, the project aims to investigate whether individuals undergoing bone marrow examinations can experience less anxiety and pain compared to standard procedures through visual and auditory distraction via VR, and whether pain relief can be made more individualized and person centered.
Specific objectives:
To evaluate if it is possible to measure anxiety-induced stress responses and pain in individuals undergoing bone marrow examinations during standard procedures with objective measurement tools (skin conductance and pulse).
To evaluate how individuals rate their health, anxiety, and pain after a bone marrow examination.
To evaluate if there is a difference in anxiety-induced stress responses and pain between patients and healthy volunteers undergoing bone marrow examinations with VR versus without VR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Control group
Bone marrow examinations according to standard procedure
Intervention group
Distraction with VR headsets during bone marrow examinations
干预措施: Distraction with VR (Virtual Reality) headsets (Behavioral)
结局指标
主要结局
Nociceptive response
时间窗: 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.
Self-reported subjective health
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Heart rate(Periprocedural)