The Effect of graded sensory stimulation by family members on agitation level and graded multimodal sensory stimulation by therapist on level of consciousness in patients with Glasgow coma score greater then or equal 8, following neurosurgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Level of Agitation will be assessed using Richmond agitation- sedation scale ( RASS)
研究概览
简要总结
The study will adopt a quasi-experimental prospective design , recruiting 42 post-neurosurgery patients with a Glasgow Coma Score (GCS) less than or equal to 8. Participants will be allocated into experimental and control groups through blocked randomization. The intervention will extend over 18 consecutive days and will be carried out in three structured phases. In the first phase, trained family members will provide graded tactile and auditory stimulation, under the supervision of the researcher. In the subsequent phases, therapists will introduce graded multimodal sensory stimulation, which will include auditory, tactile, olfactory, visual, and kinesthetic. Each stimulation session will last about 45 minutes daily, with consistent monitoring. Patients in the control group will receive only routine interactions without structured sensory input. Outcomes will be assessed at pre-, mid-, and post-intervention stages using the Richmond Agitation-Sedation Scale (RASS) for agitation, the Coma Recovery Scale-Revised (CRS-R) for consciousness, and the Zarit Caregiver Burden Scale for caregiver burden. Data will then be statistically analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •For patients Age 18 to 65 years An agitation rate of plus 2 to plus 4 based on the Richmond Agitation and Sedation Scale Glasgow coma score less than or equal to 8 Patients post first time neurosurgery for Subarachnoid haemorrhage , Space occupied lesion and craniotomy.
- •24 to 48 hours of stabilization of hemodynamic symptoms.
- •For family members Being an adult primary caregiver of the patients own family like father, mother, sibling, spouse, child and grandchild.
- •The regular presence of the selected family member during the intervention.
排除标准
- •Hemodynamic instability in patients during the intervention after recruitment into the study Requirement of emergency surgery due to increased intracranial pressure Presence of diagnosed hearing impairment or skin disorder in the area of tactile stimulation prior to surgery.
- •Patients attended by a paid caregiver.
结局指标
主要结局
Level of Agitation will be assessed using Richmond agitation- sedation scale ( RASS)
时间窗: Richmond agitation- sedation scale and Glasgow coma scale will be used as screening tool. Richmond agitation- sedation scale, Coma recovery scale and Zarit caregiver burden scale will be assessed on Day 1,7,12,18 or at discharge.
Level of consciousness will be assessed Coma recovery scale- revised and Glasgow coma scale
时间窗: Richmond agitation- sedation scale and Glasgow coma scale will be used as screening tool. Richmond agitation- sedation scale, Coma recovery scale and Zarit caregiver burden scale will be assessed on Day 1,7,12,18 or at discharge.
Caregiver burden will be assesed using Zarit Caregiver burden scale
时间窗: Richmond agitation- sedation scale and Glasgow coma scale will be used as screening tool. Richmond agitation- sedation scale, Coma recovery scale and Zarit caregiver burden scale will be assessed on Day 1,7,12,18 or at discharge.
次要结局
未报告次要终点
研究者
Dr Sakshi Palsambkar
OT Training School and Center LTMMC and GH