Role of music therapy for sleep disturbances in PediatricOncology patients in Home based setting
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Care giver or observor Reported improvement in sleep quality measured by CSHQ (child sleep habit questionnaire)
研究概览
简要总结
The study will be conducted in the pediatric oncology department in a government tertiary care hospital. After getting approval from the Institutional Ethical Committee, all those fulfilling the inclusion criteria will be enrolled in the study over the specified duration. All participants and their parents/caregivers will be informed and explained about the study, and consent will be obtained in their mother tongue. All interviews will be face-to-face using a pre-structured questionnaire. The primary socio-demographic data will be collected in the survey, such as gender, Age, type of family, parent’s education, and socioeconomic class of family. Data about cancer therapy like the type of cancer, stage of cancer, and chemotherapy drugs will be recorded. Participants will be allocated into control and case groups alternatively.Parents/caregivers of all participants in both groups will complete the Children’s Sleep Habit Questionnaire**(** CSHQ ). CSHQ is a 45-item questionnaire to identify sleep behavior in children. The answers will be recorded on a three-point scale. The cut-off for significant sleep disorder will be considered as values > 41.After enrollment, the control group will receive routine care and sleep hygiene education. In addition, the test group will be provided instrumental music played on an MP3 player with earphones for 15 minutes before bedtime. YouTube (2018b). Lullabies Retrieved from https://www.youtube.com/watch? v=I0R5b4YJHwo ]. A sleep diary will be given to the parents to monitor their children’s sleep time, children’s mood on waking up in the morning, and music therapy given or not over four weeks. ( attached )They will be instructed to follow the music therapy for at least five days/week for four weeks. We will send text message reminders to the parents/caregivers of children. Children will be assessed with a Structured questionnaire, CSHQ, and sleep diaries again at the end of 4 weeks. Things provided to parents :
1. MP3 Relaxing music audio
2. Sleep diary•
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Having sleep disturbances in Childrens Sleep Habit Questionnaire score greater than
- •2 Whose duration of diagnosis is more than one month will be included.
排除标准
- •Parents/ Caregivers who did not give consent for participation.
- •2.Children receiving palliative care.
- •3.Children with severe cognitive disorders/intellectual disabilities.
- •4.Children who had anatomical sleep breathing disorders.
- •5.Children having severe hearing impairment.
结局指标
主要结局
Care giver or observor Reported improvement in sleep quality measured by CSHQ (child sleep habit questionnaire)
时间窗: AT BASELINE AND AT THE END OF 4 WEEKS
次要结局
- 1.INCREASE IN TOTAL SLEEP TIME AS COMPARED TO BASELINE(2.DECREASE IN SLEEP ONSET LATENCY)