Effect of virtual reality headset device on pain, fear and anxiety in Paediatric Cancer Patients during Lumbar Punctures (LP) at a Tertiary Care Centre in Mumbai. Open label RCT
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of VR as a distraction technique in reducing
研究概览
简要总结
The study will be initiated after ethical approval from IEC at TMH .children for intrathecal injection during LP will be allowed to participate in the study subject to written informed consent of parents and assent of child . Eligible participant according to inclusion criteria will take into participation . The investigator will tell and discuss about the purpose of VR glasses and what they are hearing and seeing through the goggles. like swimming with marine animals, Riding roller coaster Exploring the forest through the eye of the woodland species . The pre assessment for pain fear and anxiety will be performed by the investigator by using Wong backer pain scale, CAM-S and CFS before the procedure. The VR goggles will remain throughout the procedure. Post procedure VR headset device will be removed and the response will be recorded by the investigator .The investigator collect data after 5 minutes after LP T2 for pain, fear and anxiety with the help of standardized tool WBS CSF and CAMS Investigator collect data for pain after 15 minutes T3 of procedure with the help of WBS . Investigator collect data for pain after 30 minutesT4 of procedure with the help of WBS . Recorded data will be shared with the statistician for data analysis.
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
- 7.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Leukemia in the age group of 7-15 years undergoing L.P. for chemotherapy.
- •Who is cognitively appropriate when assessed by a pediatrician and psychologist as appropriate to use VR, with consent from parents or guardians.
- •Caregivers and children who can understand English/Hindi/Marathi.
排除标准
- •Active nausea or vomiting
- •Developmental delay: Children who cannot verbalize.
- •Children who cannot tolerate applying a VR headset device during the procedure.
- •History of seizures.
结局指标
主要结局
To evaluate the effectiveness of VR as a distraction technique in reducing
时间窗: pain is assessed consistently across all participants. Pain levels will be | measured at four time points using the Wong-Baker FACES WBS Pain Rating Scale in both the VR intervention group and the standard care group. The assessment time points are as | follows T1 at 5 minutes before the procedure | T2at Immediately 5 minutes post lumbar puncture LP | T3 at 15 minutes after the LP | T4 at 30 minutes after the LP
pain during paediatric lumbar punctures.by using Wong baker pain scale
时间窗: pain is assessed consistently across all participants. Pain levels will be | measured at four time points using the Wong-Baker FACES WBS Pain Rating Scale in both the VR intervention group and the standard care group. The assessment time points are as | follows T1 at 5 minutes before the procedure | T2at Immediately 5 minutes post lumbar puncture LP | T3 at 15 minutes after the LP | T4 at 30 minutes after the LP
次要结局
- To compare the pain, fear and anxiety levels experienced during LP of(pediatric patients receiving VR intervention versus those receiving standard care.by using the)
研究者
Dr Manisha Pawar
Tata Memorial hospital Mumbai