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临床试验/CTRI/2024/07/071715
CTRI/2024/07/071715尚未招募不适用

To Assess the prevalence and Risk factors of Anxiety and Sleep Disruption in Mothers of critically ill Neonates admitted to Neonatal Intensive Care Unit.

Amaldev Vasudevan Pillai1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年9月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
Incidence of Anxiety and Sleep Disturbance

研究概览

简要总结

This Prospective Observational Cross Sectional study  assesses  the prevalence and risk factors of anxiety and sleep disruption in mothers of critically ill neonates admitted to Neonatal Intensive Care Unit in Government Medical College Aurangabad. The study participants are 200 mothers of critically ill neonates admitted to NICU who have visited the NICU for atleast 4 days are approached for the study within 10 days of the admission of their neonate. Standardized PROMIS (Patient Reported Outcomes Measurement System)  Questionnaire are utilized for categorizing the anxiety and sleep disturbance in mothers as mild ,moderate and severe based on the T scores obtained using these questionnaire. Mothers who are already diagnosed cases of anxiety and insomnia and who do not wish to participate in the study are excluded from the study. The influence of age and parity  of mother ,socioeconomic background and past NICU experiences of mother in the development of anxiety and sleep disturbances will also be studied. The influence of healthcare staff communication regarding the condition of the neonate and about maternal adaptation in NICU in the development of anxiety and sleep disruption will also be studied.

研究设计

研究类型
Observational

入排标准

年龄范围
17.00 Day(s) 至 39.00 Day(s)(—)
性别
Female

入选标准

  • Mothers of Critically ill Neonates admitted in NICU during the period of study, who have visited the NICU for atleast 4 days; are approached for the study within 10 days of the admission of their neonate.

排除标准

  • Mothers who are not willing to participate in the study.
  • Mothers of Neonates admitted to NICU who already have been diagnosed with Anxiety and Insomnia before the study.

结局指标

主要结局

Incidence of Anxiety and Sleep Disturbance

时间窗: within 10 days

次要结局

  • Relationship of Age ,parity, previous NICU experiences, socioeconomic status on development of anxiety and sleep disruption.(within 10 days)

研究者

发起方
Amaldev Vasudevan Pillai
申办方类型
Other [Borne by the Principal Investigator]
责任方
Principal Investigator
主要研究者

Amaldev Vasudevan Pillai

Government Medical College and Hospital Aurangabad

研究点 (1)

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