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临床试验/CTRI/2025/02/080800
CTRI/2025/02/080800招募中2 期

Effect of Receptive Indian Music Intervention on Pain and Anxiety among laboring mothers

Self funded1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月3日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Pain Level Measured using the Visual Analog Scale VAS for pain at baseline before intervention and after the intervention

研究概览

简要总结

Labor pain and anxiety are prevalent during childbirth and can have significant effects on both maternal and fetal outcomes (1). While pharmacological interventions are widely used, there is growing interest in non-pharmacological approaches such as music therapy (2). Music has been shown to reduce anxiety and pain in various clinical settings (3), and its calming effects could be especially beneficial during labor. Indian music, known for its rhythmic and soothing characteristics, could offer a culturally relevant therapeutic tool for pain and anxiety management in laboring mothers (4). However, limited research exists regarding Indian music and its specific impact on laboring women, thus necessitating this investigation (5, 6).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Singleton Pregnancy with Cephalic Presentation Pregnant Female in active labour Age 18 to 40 years Ability to understand the Trial Procedure and Gives Informed Consent.

排除标准

  • High-risk pregnancies Patient having non reassuring Fetal heart rate on Cardiotocography History of psychiatric illness or diagnosed anxiety disorders Hearing impairments or conditions making it difficult to listen to music Use of any pain relieving medications or other interventions during the trial.

结局指标

主要结局

Pain Level Measured using the Visual Analog Scale VAS for pain at baseline before intervention and after the intervention

时间窗: After at least 30 mins of music intervention

Anxiety Level Measured using the Subjective Units of Distress Scale SUDS at baseline and after the intervention

时间窗: After at least 30 mins of music intervention

次要结局

  • First hour breast feeding(within one hour of birth)

研究者

发起方
Self funded
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Bhavneet Bharti

Dr B R Ambedkar Institute of Medical Sciences , SAS Nagar Punjab

研究点 (1)

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