跳至主要内容
临床试验/CTRI/2025/12/099989
CTRI/2025/12/099989尚未招募Unknown

Impact of educational training on maternal bonding, self-efficacy, and self-confidence in mothers of preterm neonates admitted in NICU.

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2027年1月1日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
124
试验地点
1
主要终点
Change in test scores before and seven days after intervention which is measured using validated tools (Mother-to-Infant Bonding Scale [MBS], Perceived Maternal Parenting Self-Efficacy [PMP-SE] scale, and Parenting Sense of Competence Scale [PSCS]).

研究概览

简要总结

This study is randomized, open blind, and parallel which compares the test scores of mothers who have preterm babies admitted in the NICU. Standardized tests will be given 72 hours postpartum and again 7 days post-intervention to both groups. The primary outcome is the change in test scores before and seven days after intervention which is measured using validated tools (Mother-to-Infant Bonding Scale [MBS], Perceived Maternal Parenting Self-Efficacy [PMP-SE] scale, and Parenting Sense of Competence Scale [PSCS]). The secondary outcome will be the difference in post-interventional scores between interventional and control groups at 7 days post-intervention. Another secondary outcome will be the proportion of mothers in each arm achieving a clinically meaningful increase in the Perceived Maternal Self-Efficacy scores, defined as an increase of greater than or equal to 0.5 times the baseline standard deviation.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Mothers of preterm neonates that were admitted in the NICU for routine preterm care 2) Mothers of preterm babies who did not require advanced interventions like mechanical ventilation, CPAP, Inotropes, etc.
  • Mothers of pre-term babies who did not require advanced resuscitation/intervention during childbirth 4) Mothers who did not have a diagnosed psychiatric illness/chronic illness 5) Mothers who consented to be in the study.

排除标准

  • Mothers who are unwilling to participate 2) Mothers of neonates with complex conditions like congenital heart diseases, congenital anomalies, genetic syndromes, etc.

结局指标

主要结局

Change in test scores before and seven days after intervention which is measured using validated tools (Mother-to-Infant Bonding Scale [MBS], Perceived Maternal Parenting Self-Efficacy [PMP-SE] scale, and Parenting Sense of Competence Scale [PSCS]).

时间窗: within 72 hours of postpartum and seven days post-intervention

次要结局

  • Difference in post-intervention scores between intervention and control groups at 7 days post-intervention.(Seven days post-intervention)
  • Proportion of mothers in each arm achieving a clinically meaningful increase in Perceived Maternal Parenting Self-Efficacy score, defined as an increase of greater than or equal to 0.5 times the baseline standard deviation(Seven days post-intervention)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr. Gayathri Renganathan

Kasturba Medical College, Mangalore

研究点 (1)

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