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临床试验/CTRI/2024/12/077792
CTRI/2024/12/077792尚未招募2/3 期

EFFECT OF MUSIC THERAPY ON MATERNAL STRESS LEVELS AND VOLUME OF EXPRESSED BREAST MILK – A PILOT RANDOMIZED CONTROLLED TRIAL

Dr Himang Bhardwaj1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年12月10日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
1.To determine the effect of music therapy on reducing stress level in lactating mothers.

研究概览

简要总结

This pilot randomized control trial will include 80 newborn mother dyads, 40 each in the intervention and the control group. A written informed consent will be sought from the parents/legal guardian. The details of newborn history, finding of clinical examination and results of investigation will be recorded in the predesigned proforma. Maternal and family characteristics, ANC details and birth related history, comorbid conditions, physical characteristics and investigation results will be meticulously enquired and entered in the proforma. Block randomization including blocks of 4 will be utilized for recruitment of subjects in the two arms.

For expression of milk in the control group, the mother will be made to sit in the designated area for 10 minutes after which expression of milk will be done by aseptic measures. For the study group, the mother will be seated in the same place and will be made to listen to a preselected light instrumental music with the help of earpods for 30 minutes. The expression of milk will be done after 20 minutes while she still keeps listening to the music adopting the same procedure as previously mentioned.

The volume of milk expressed will be quantified and fed to the baby as advised by the treating neonatologist. The trial will commence after obtaining the registration from CTRI

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Mother along with the preterm newborns admitted in Neonatal Intensive care unit.

排除标准

  • Sick Mothers or mothers taking any drugs which are contraindicated during lactation.

结局指标

主要结局

1.To determine the effect of music therapy on reducing stress level in lactating mothers.

时间窗: Early Morning (6am-9am)

2.To determine the effect of music therapy on augmenting the volume of expressed breast milk and maternal stress hormone

时间窗: Early Morning (6am-9am)

次要结局

  • To explore the maternal and neonatal factors affecting the milk output.(Early Morning (6am-9am))

研究者

发起方
Dr Himang Bhardwaj
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Himang Bhardwaj

JNMCH AMU

研究点 (1)

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