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临床试验/NCT07704541
NCT07704541尚未招募不适用

The Effect of Mandala Art Therapy on Fear and Anxiety of Childbirth in Expectant Fathers Waiting Outside the Delivery Room: A Randomized Controlled Study

Inonu University0 个研究点目标入组 148 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
148
主要终点
Childbirth Fear

研究概览

简要总结

This randomized controlled trial is designed to evaluate the effectiveness of mandala art therapy in reducing childbirth fear and state anxiety among fathers whose partners are nulliparous pregnant women and who are waiting in the obstetric ward waiting area during labor. Eligible participants will be randomly allocated to either the intervention or the control group. Fathers assigned to the intervention group will participate in a single 20-25-minute mandala art therapy session, whereas those in the control group will receive standard care without any additional intervention. Childbirth fear and state anxiety will be assessed using the Fathers' Birth Fear Scale and the State subscale of the Spielberger State-Trait Anxiety Inventory, respectively, at baseline and immediately following the intervention. The findings of this study are expected to provide evidence regarding the effectiveness of mandala art therapy as a non-pharmacological intervention for alleviating childbirth-related fear and anxiety among expectant fathers.

详细描述

This study is a randomized controlled trial designed to evaluate the effectiveness of mandala art therapy in reducing childbirth fear and state anxiety among expectant fathers whose partners are nulliparous pregnant women and who are waiting in the obstetric ward waiting area during labor. Eligible participants will be randomly allocated to either the intervention or the control group using a simple randomization procedure. Participants assigned to the intervention group will receive a single, individually administered mandala art therapy session lasting approximately 20-25 minutes. During the session, participants will be encouraged to select their preferred mandala patterns and colors, thereby facilitating individual expression and engagement in the therapeutic process. Participants in the control group will receive routine care without any additional intervention and will undergo the same assessment procedures as the intervention group. Data will be collected at two time points: immediately before the intervention (baseline) and immediately after the intervention. The primary outcome of the study is childbirth fear, while the secondary outcome is state anxiety.

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
Double (Participant, Care Provider)

盲法说明

Blinding of participants and investigators is not feasible due to the nature of the intervention (mandala art therapy). Participants are aware of the activity they receive, and the intervention provider is also aware of group allocation. Outcome assessment is performed using standardized self-report scales.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Fathers whose partners are nulliparous pregnant women Fathers aged 18 years and older Fathers whose partners are admitted for planned vaginal delivery Fathers present in the obstetric waiting area during the study period Fathers who are able to read and understand Turkish Fathers who voluntarily agree to participate in the study

排除标准

  • Presence of obstetric emergency or unplanned change in delivery method (e.g., emergency cesarean section) History of diagnosed psychiatric disorders requiring treatment (e.g., anxiety disorders) Inability to understand or complete study questionnaires Absence from the waiting area during the intervention period

研究组 & 干预措施

Control Group

No Intervention

Participants in this group will receive no intervention. They will complete the same pre-test and post-test assessments as the intervention group at the same time points.

Mandala Art Therapy Group

Experimental

Participants in this group will receive mandala art therapy. The intervention consists of a 20-25 minute individual mandala coloring activity conducted in the obstetric waiting area. Participants will be provided with a mandala coloring book and colored pencils and will freely choose patterns and colors.

干预措施: Mandala Art Therapy (Behavioral)

结局指标

主要结局

Childbirth Fear

时间窗: Baseline and immediately after intervention (approximately 30-45 minutes post-intervention)

Childbirth fear will be assessed using the Fathers' Birth Fear Scale (BDKÖ). The scale measures fathers' fear related to childbirth process and hospital-related concerns. Higher scores indicate higher levels of childbirth fear. Assessments will be performed before and after the mandala art therapy intervention.

次要结局

未报告次要终点

研究者

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

Melike TAN ÇELİK

master's student

Inonu University

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