The Effect of Pre-recorded Lullaby in a Childs Own Mothers Voice on Radiotherapy Procedure under Sedation : An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Other (Terminated)
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- To determine the number of episodes of intra-procedure spontaneous movements under sedation, interfering with radiotherapy treatment (observed on telemetry CCTV monitor).
研究概览
简要总结
Though process of delivering radiotherapy is painless, sedation is often required for pediatric patients undergoing radiotherapy to ensure their comfort, anxiety reduction, and immobilization during the procedure.However, the repeated use of general anesthetics, such as benzodiazepines and ketamine, in pediatric patients has raised concerns about potential long-term neurocognitive effects on the developing brain.While anesthesia-sparing distraction methods have been attempted, they are challenging to implement successfully in children under three years of age.Music therapy has been traditionally used to calm anxious patients.Recently, in our centre we have started playing pre-recorded lullaby in patient’s own mothers voice as an adjuvant method along with routine sedatives to achieve anxiolysis and immobilisation during radiotherapy. While some of the anaesthesiologists are adopting this new methodology, rest of them are still following the conventional method (delivery of sedatives only, without playing the lullaby). In this prospective observational cohort study, we aim to observe the effect of playing a prerecorded lullaby in the patient’s own mother’s voice as an adjuvant method alongside routine sedation to achieve anxiolysis and immobilization during radiotherapy and compare them with the conventional general anesthesia technique.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 3.00 Year(s)(—)
- 性别
- All
入选标准
- •Pediatric patients of both the sex less than three years of age undergoing radiotherapy.
排除标准
- •Exclusion Criteria: Patients with a history of severe cognitive impairments or hearing impairments that could affect their response to the lullaby will be excluded.
- •Patients unfit for radiotherapy under sedation (eg.
- •Inadequate NBM hours, Acute lower respiratory tract infection, fever) will be excluded.
- •Patients with prolonged fasting period (more than 8 hours) will be excluded.
结局指标
主要结局
To determine the number of episodes of intra-procedure spontaneous movements under sedation, interfering with radiotherapy treatment (observed on telemetry CCTV monitor).
时间窗: During the procedure of radiotherapy
次要结局
- To observe the total dose requirement (per kg body weight) of general anesthetics (midazolam and ketamine) per episode of radiotherapy.(During radiotherapy)
- To observe immediate post procedure sedation status as per AVPU scale after each episode of radiotherapy(Immediate post radiotherapy)
- To observe recovery time for each patient after completion of radiotherapy(after completion of radiotherapy at recovery room)
研究者
Dr Uddalak Chattopadhyay
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital Varanasi
