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临床试验/NCT06257186
NCT06257186Unknown不适用

Investigating the Effect of Art Therapy on Women With Fear of Childbirth During Pregnancy: A Mixed Method Study

KK Women's and Children's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Fear or Childbirth (FOC)

研究概览

简要总结

Childbirth is a multifaceted experience and could involve both positive and negative feelings. Feelings of limited capability in the face of childbirth may result in a condition termed as Fear of Childbirth (FOC), which contributes to significantly higher risks of birth complications resulting in psychological trauma. This study aims to examine the effects of Art Therapy (AT) on FOC, perceived maternal parental self-efficacy, postpartum maternal infant bonding and postpartum depression.

A mixed-methods sequential explanatory design will be used. Phase one will adopt a quasi-experimental study design. Women who are aged 21 and above, English literate and having a singleton pregnancy will be approached to fill in the Fear of Birth Scale (FOBS). Participants with FOBS score of 60 and above will be considered as having FOC and will be invited to participate in the AT intervention. Participants who are agreeable to receive AT will be recruited in the experimental group. Participants who declined to participate in AT will receive routine antenatal care (control group). Outcomes that will be measured in both groups include perceived maternal self-efficacy, maternal infant bonding, and maternal depression after childbirth. A qualitative descriptive design will be used in phase two. Semi-structured interviews will be conducted with the participants to explore their experiences of the AT. Descriptive analysis, independent sample t-test, paired sample t-test, and regression analysis will be used for analysis of the quantitative data in phase one. Qualitative data from phase two will be analysed using thematic analysis.

Findings of this study may provide evidence on the use of AT to cope with FOC during pregnancy. If proven to be beneficial, AT may potentially be introduced and advocated as an intervention for women with FOC.

详细描述

Research Design:

A mixed-methods sequential explanatory design will be used. Phase one will be quasi-experimental study design, comparing women with FOC who received art therapy (experimental group) and women who received routine antenatal care (control group). A qualitative descriptive design will be used in phase two to explore the experiences of the participants who had art therapy for FOC.

Sampling:

Convenience sampling will be used for phase one. Purposive sampling will be used for phase two, for which only participants who had undergone the art therapy intervention will be invited to participate.

Consented participants will be invited to fill in the Fear of Birth Scale (FOBS). Participants with FOBS score of 60 and above will be enrolled into the study. Participants will be invited to participate in the Art Therapy intervention (experimental group). If participants are not agreeable to participate in the art therapy, they will be allocated to the control group.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Aged between 21 and 50 years old
  • English literate
  • Having an intrauterine singleton live pregnancy
  • Currently in the second trimester of the pregnancy (between 13 to 27 weeks of pregnancy)
  • Fear of Birth Scale (FOBS) score of 60 and above

排除标准

  • With contraindication for vaginal birth (for example placenta covering cervix)
  • With obstetric complications during pregnancy such as fetal anomaly that is incompatible with life
  • With current depression requiring medical intervention
  • Who had stillborn delivery
  • Phase II Inclusion Criteria Enrolled participants who had undergone the Art Therapy intervention in phase one

研究组 & 干预措施

Art Therapy

Experimental

Women in the experimental group will be offered a series of three to five art therapy sessions, depending on the participants' needs/preferences. The art therapy sessions will be given anytime after consent has been obtained till approximately 36 weeks of gestation. The art therapy sessions are in addition to routine antenatal care.

干预措施: Art Therapy (Other)

Routine Antenatal Care

No Intervention

Women in the control group will receive routine antenatal care.

结局指标

主要结局

Fear or Childbirth (FOC)

时间窗: From Screening (Second Trimester) to between 37 and 40 Weeks of Gestation

FOC is measured by the Fear of Birth Scale (FOBS). The FOBS score ranges from 0 to 100. A higher score represents a higher value of fear of childbirth.

次要结局

  • Perceived Maternal Self-efficacy(Measured after study intervention period, one month after childbirth)
  • Maternal Depression after Childbirth(Measured after study intervention period, one month after childbirth)
  • Maternal Infant Bonding(Measured after study intervention period, one month after childbirth)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ang Mei Qi

Nurse Clinician

KK Women's and Children's Hospital

研究点 (1)

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