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临床试验/CTRI/2025/09/095448
CTRI/2025/09/095448尚未招募2 期

Effect of sleep hygiene education on sleep patterns and behavior in neurodiverse children

Kasturba Medical College Mangalore2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年10月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
32
试验地点
2
主要终点
a.proportion of children with sleep abnormalities.

研究概览

简要总结

The study will commence after taking permission from the institutional ethics committee and superintendent of the respective hospitals. Sample recruitment will start after CTRI registration The caregivers of the children visiting hospitals will be approached. written informed consent will be taken from all study participants   who will be selected based on inclusion and exclusion criteria .They will be interviewed about sleep habits of their children, and the data collection will be done by a child sleep habits, questionnaire (CSHQ ) ,a structured questionnaire which will be used pre-interventional in Google form-format by the investigator during an interview conducted in the language in which the caregivers are comfortable. Following this the the children with sleep abnormalities will be recruited into the intervention where caregivers will be taught about sleep hygiene methods via a module developed by the investigator in the language, they are comfortable in a one-on-one session, with a standard time of 20 minute each. Participants will be provided opportunity to clear doubts. They will be asked to follow these methods for the next two months. Text messages through WhatsApp or SMS will be sent thrice a week and phone call will be made once a week to ensure compliance. After this, 2 months post-intervention the caregivers will be interviewed by the investigator about the changes in child, sleep pattern and behaviour following the intervention using CSHQ and a caregiver satisfaction scale (made by the investigator) . Once the questionnaire is complete, data will be checked for completeness, inconsistencies, and missing values, with incomplete responses excluded from the final analysis. Descriptive statistics will be used to analyse baseline characteristics of participants, including demographics and reported sleep issues, through frequencies, percentages, mean, and standard deviation. Pre- and post-intervention scores will be compared using paired t-test or a Wilcoxon signed-rank test .Effect size calculation will be performed using Cohen’s d or rank-biserial correlation to measure the intervention’s impact on sleep improvement. Significance level and interpretation will be based on a p-value of <0.05.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
4.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • All the participants are caregivers of individuals between the ages of 4 to 12 who are fluent in either Hindi , English or Kannada and willing give consent.
  • And are on the usual course of treatment.

排除标准

  • Those who do not give consent, incomplete entries, on sleep modifying drugs or do not meet the language criteria.

结局指标

主要结局

a.proportion of children with sleep abnormalities.

时间窗: a.proportion of children with sleep abnormalities - baseline | b.Changes in sleep pattern and behaviour following sleep intervention. - after two months | c.caregiver satisfaction post intervention - after two months

b.Changes in sleep pattern and behaviour following sleep intervention.

时间窗: a.proportion of children with sleep abnormalities - baseline | b.Changes in sleep pattern and behaviour following sleep intervention. - after two months | c.caregiver satisfaction post intervention - after two months

c.caregiver satisfaction post intervention

时间窗: a.proportion of children with sleep abnormalities - baseline | b.Changes in sleep pattern and behaviour following sleep intervention. - after two months | c.caregiver satisfaction post intervention - after two months

次要结局

未报告次要终点

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Raj Amrit Ranjan

Kasturba Medical College Mangalore

研究点 (2)

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