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临床试验/NCT07775963
NCT07775963已完成不适用

Management of Fear of Childbirth With Art-Based Approaches: A Randomized Controlled Trial on the Effectiveness of Mandala Coloring and Music Listening

Osmaniye Korkut Ata University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Fear of Childbirth Assessed Using the Wijma Delivery Expectancy/Experience Questionnaire Version A

研究概览

简要总结

This randomized controlled trial evaluates the effects of mandala coloring and music listening on fear of childbirth among pregnant women. Participants are randomly assigned to one of three groups: a mandala coloring group, a music listening group, or a control group. The interventions are non-pharmacological, art-based approaches intended to support relaxation and reduce fear related to childbirth. Fear of childbirth is assessed before and after the interventions using validated measurement tools. The study aims to determine whether mandala coloring and music listening are effective in reducing fear of childbirth and to compare the effectiveness of these two approaches with routine care.

详细描述

Fear of childbirth is a common concern during pregnancy and may negatively affect women's psychological well-being and childbirth experiences. Non-pharmacological approaches that are simple, accessible, and easy to implement may help pregnant women cope with childbirth-related fear.

This study is designed as a randomized controlled trial to evaluate and compare the effectiveness of two art-based interventions, mandala coloring and music listening, in reducing fear of childbirth among pregnant women. Eligible participants are randomly assigned to three groups: the mandala coloring group, the music listening group, and the control group.

Participants assigned to the mandala coloring group complete a structured mandala coloring intervention. Participants assigned to the music listening group receive a structured music listening intervention. Participants in the control group receive routine care without either of these additional interventions.

Fear of childbirth is assessed using validated measurement instruments before and after the intervention period. Changes in outcome measures are compared within and between the study groups to determine the effects of the interventions. The study also compares mandala coloring and music listening to determine whether one approach is more effective in reducing fear of childbirth.

The findings are expected to provide evidence regarding the use of simple, non-pharmacological, art-based approaches for managing fear of childbirth during pregnancy.

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)

盲法说明

The outcome assessor was blinded to the participants' group assignments.

入排标准

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

入选标准

  • •Pregnant women aged 18-35 years
  • •Primiparous pregnant women
  • •Pregnant women who met the gestational week criteria specified in the study protocol
  • •Pregnant women with fear of childbirth
  • •Ability to communicate in Turkish
  • •Voluntary agreement to participate in the study

排除标准

  • •Presence of a high-risk pregnancy or pregnancy-related complication
  • •Presence of a diagnosed psychiatric disorder or use of psychiatric medication
  • •Presence of a condition that could prevent participation in the interventions
  • •Participation in another intervention aimed at reducing fear of childbirth
  • •Withdrawal from the study or failure to complete the intervention and outcome assessments

研究组 & 干预措施

Mandala Coloring Group

Experimental

Participants assigned to this group received the mandala coloring intervention in addition to routine care. The intervention was designed to reduce fear of childbirth through a structured art-based activity.

干预措施: Mandala Coloring (Behavioral)

Music Listening Group

Experimental

Participants assigned to this group received the music listening intervention in addition to routine care. The intervention was designed to promote relaxation and reduce fear of childbirth.

干预措施: Music Listening (Behavioral)

Control Group

No Intervention

Participants assigned to the control group received routine care and did not receive the mandala coloring or music listening intervention.

结局指标

主要结局

Fear of Childbirth Assessed Using the Wijma Delivery Expectancy/Experience Questionnaire Version A

时间窗: Baseline and immediately after the intervention

Fear of childbirth was assessed using the Wijma Delivery Expectancy/Experience Questionnaire Version A. The questionnaire consists of 33 items and provides a total score ranging from 0 to 165. Higher scores indicate a higher level of fear of childbirth. The questionnaire was administered before and after the intervention to evaluate changes in fear of childbirth among the mandala coloring, music listening, and control groups.

次要结局

  • Pain Level Assessed Using the Visual Analog Scale(Baseline and immediately after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

CANSU AĞRALI

Principal Investigator

Osmaniye Korkut Ata University

研究点 (1)

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