Efficacy of smartphone based virtual reality for the alleviation of anxiety during dermatosurgical procedures: A Mixed method stratified randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- To assess and compare the end point anxiety scores in patients receiving virtual reality during dermatological procedures versus control patients who did not receive virtual reality as measured by VAS (A).
研究概览
简要总结
Anxiety and pain are the commonest symptoms in clinical practice and effective management of these is crucial to optimise medical procedures, boost patients’ satisfaction, reduce hospital stay and minimise long-term analgesic dependence. Hence, some sort of distraction and relaxation techniques becomes necessary to keep the patient at ease during the procedure. Various modalities have been tried including music 1, watching videos 1, virtual reality (VR) 2, stress balls 3, etc., The use of virtual reality (VR) technology has emerged as a potential tool to distract patients and to modify their perception of pain 2. Previous studies have shown that distraction is the most common technique used to reduce pain in short invasive medical procedures 4. Techniques like watching video via VR prevents patients from seeing what is happening in the real world and directs the focus on what is going on in the virtual world and it works by utilizing some part of human’s cognitive capacity leaving less of it available for processing pain 2. Its adoption in clinical practice especially in dermatology remains limited.
Dermatology practice also includes several minor procedures for skin lesions, including skin cancers, most of which are done performed under topical or injectable local anaesthesia. Pain and anxiety during the procedure is a significant concern since the patient is alert and awake intraoperatively and can be challenging for both clinicians and patients 3. Several previous studies have assessed the role of VR in the management of pain and anxiety in medical and surgical procedures. However, studies the efficacy of VR on pain and anxiety during dermatological procedures is scarce.
Hence, we propose to study the efficacy of VR on pain and anxiety during dermatological procedures which has not been evaluated so far to the best of our knowledge.
This study will assess the efficacy of virtual reality as a clinical tool in the alleviation of pain and anxiety during dermatological procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ≥18 years 2)Those being planned for cryosurgery, biopsy, electro and radiosurgery and intralesional therapy.
排除标准
- •Patients who are coming for follow up visits for dermatological procedures 2) Patients having impairment of vision 3) Patients having impairment of hearing.
- •Patients in whom the virtual reality headset will cause obstruction in the dermatological procedure owing to the location of the lesion.
- •Patients not comfortable wearing the virtual reality headset or undergoing virtual reality intervention.
- •Seizures.
结局指标
主要结局
To assess and compare the end point anxiety scores in patients receiving virtual reality during dermatological procedures versus control patients who did not receive virtual reality as measured by VAS (A).
时间窗: Baseline
次要结局
- To assess & compare the end point anxiety scores in patients receiving virtual reality during dermatological procedures versus control patients who did not receive virtual reality as measured by short version of STAI.(Baseline)
- To assess & compare the end point pain scores (VAS(P)), galvanic skin response & heart rate measurements & satisfaction scores in patients receiving virtual reality during dermatological procedures versus control patients who did not receive virtual reality.(Baseline)
- To explore the perspectives of patients & providers on use of VR as an adjunct to dermatosurgical procedures(Baseline)
- To assess the physician satisfaction as measured using a Likert scale in the two groups(Baseline)
研究者
Dr Karthik L
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry