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临床试验/NCT07452861
NCT07452861已完成不适用

Effect of Ney Music During the Non-Stress Test on Maternal State Anxiety, Autonomic Regulation, and Fetal Reactivity: A Randomized Controlled Trial

Hediye Karakoç1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年5月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
1
主要终点
State Anxiety (STAI-S Score)

研究概览

简要总结

This randomized controlled trial evaluates the effects of listening to ney music during routine non-stress testing (NST) on maternal psychological and physiological responses and fetal reactivity. Maternal anxiety during NST may activate sympathetic pathways and potentially influence fetal heart rate patterns. A total of 126 pregnant women at ≥32 weeks' gestation were randomly assigned to either an intervention group (ney music during NST) or a control group (standard NST care). Maternal state anxiety (State-Trait Anxiety Inventory-State), perceived stress and anxiety (DASS-21), blood pressure, heart rate, respiratory rate, oxygen saturation, and NST reactivity were assessed before and after the procedure. The primary objective is to determine whether ney music reduces acute maternal state anxiety during NST. Secondary objectives include evaluating its effects on autonomic physiological parameters and fetal NST reactivity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age ≥18 years,
  • gestational age ≥32 weeks,
  • singleton pregnancy,
  • absence of known fetal cardiovascular anomalies,
  • no visual or hearing impairments,
  • having eaten at least two hours before the NST,
  • bladder emptied prior to the procedure,
  • voluntary participation.

排除标准

  • pre-existing maternal medical conditions (hypertension, diabetes, obesity),
  • multiple pregnancy,
  • known fetal abnormalities or fetal distress,
  • inherited anemia or sexually transmitted infections.

研究组 & 干预措施

Ney Music During NST

Experimental

Pregnant women listened to ney music ("Aşkın Yolculuğu") via headphones for 20 minutes during routine non-stress testing (NST).

干预措施: Ney Music (Behavioral)

Standard NST (No Music)

No Intervention

No Intervention

结局指标

主要结局

State Anxiety (STAI-S Score)

时间窗: Immediately before NST and immediately after NST (20 minutes)

Change in maternal state anxiety measured using the State-Trait Anxiety Inventory-State (STAI-S) before and immediately after the non-stress test (NST).

次要结局

  • Oxygen Saturation (%)(Before and immediately after NST (20 minutes))
  • NST Reactivity (Reactive vs Non-reactive)(During 20-minute NST session)
  • Systolic Blood Pressure (mmHg)(Before and immediately after NST (20 minutes))
  • Diastolic Blood Pressure (mmHg)(Before and immediately after NST (20 minutes))
  • Heart Rate (beats per minute)(Before and immediately after NST (20 minutes))
  • Respiratory Rate (breaths per minute)(Before and immediately after NST (20 minutes))

研究者

发起方
Hediye Karakoç
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hediye Karakoç

KTO Karatay University

KTO Karatay University

研究点 (1)

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