Virtual Reality to Reduce Pain and Anxiety in Hematological Cancer Patients Undergoing Invasive Procedures: Protocol for a Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 365
- 试验地点
- 1
- 主要终点
- Change in pain levels using the Numeric Rating Scale (0-10)
研究概览
简要总结
The goal of this clinical trial] is to study the effectiveness of Virtual Reality (VR) in reducing pain and anxiety during painful procedures for patients with hematological malignancies The main question[s] it aims to answer are:
Does VR effectively reduce pain during painful procedures for patients with hematological malignancies ? Does VR effectively reduce anxiety during painful procedures for patients with hematological malignancies ? Interventional group (intra-group comparaison): This design allows each patient to act as his own control.: The intervention consists of a complete sequence involving three phases: Period 1 (standard care), a washout period of at least seven days, and Period 2 (VR session).
External control group (inter-group comparaison): Patients will be assigned to the intervention group first, and then a matching external control patient will be selected based on age and type of procedure.
详细描述
This study is a prospective interventional crossover trial designed to evaluate the efficacy of Virtual Reality during painful procedures, including Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, and chemotherapy. Previous studies have suggested that virtual reality (VR) can distract patients from painful stimuli, enhance the quality of healthcare, and improve overall patient well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being ≥ 6 years old
- •having a confirmed diagnosis of a hematological malignancy
- •undergoing at least one of the following procedures: Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, or Chemotherapy.
排除标准
- •unstable or photosensitive epilepsy
- •hearing, visual, or inner ear impairments
- •severe psychiatric, cognitive, or mental disorders
- •Contagious diseases
- •Communication difficulties
- •Patients who withdraw consent
- •Patient who remove the VR headset during the procedure
研究组 & 干预措施
internal control design
The intervention consists of a complete sequence involving three phases: Period 1 (standard care), a washout period of at least seven days, and Period 2 (VR session during the same procedure).
干预措施: VR session (Device)
external control group
This arm consists of patients who will receive only standard care throughout the study. These external control participants will be matched to the interventional group based on age and procedure type, ensuring comparability between groups.
干预措施: VR session (Device)
结局指标
主要结局
Change in pain levels using the Numeric Rating Scale (0-10)
时间窗: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure
The Numeric rating scale (NRS) of pain is a scale from 0 to 10, where scores from 0 to 3 indicate mild pain, 4 to 6 indicate moderate pain, and 7 to 10 indicate severe pain. The NRS has been proven valid and reliable for measuring cancer-related pain. It will be assessed within 5 minutes before the procedure and within 5 minutes after the procedure during the two periods (standard care, VR session)
次要结局
- Change in Anxiety using the Spielberger State-Trait Anxiety Inventory (Y1 and Y2)(Trait anxiety: Baseline State anxiety: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure)
研究者
Yesmine Amara
Principal Investigator-PhD student
University of Sfax