跳至主要内容
临床试验/NCT05503056
NCT05503056已完成不适用

The Utilization of Art Therapy During Pregnancy to Reduce the Incidence of Postpartum Depression

Medstar Health Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022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
已完成
发起方
入组人数
100
试验地点
1
主要终点
utilization of behavioral health/psychology/psychiatry services during pregnancy and postpartum

研究概览

简要总结

This is a prospective study examining the potential impact art therapy has on postpartum depression and mother-baby bonding in women. Women who receive care at Washington Hospital Center's will be recruited for this study.

详细描述

The purpose of this research study is to assess whether alternative mental health interventions positively impacts maternal-infant bonding and postpartum depression rates in women. Postpartum depression continues to be a prevalent concern for mothers and families in the United States, with current estimates demonstrating 10-20% of women being diagnosed within one year of birth. The risks of developing postpartum depression are not well known, with maternal anxiety and stress during pregnancy being one of the proposed predisposing factors. Women with high-risk pregnancies are particularly susceptible to higher levels of stress and depression, during their pregnancy thus leaving them at great risk for postnatal depression. Given this association, finding ways to alleviate stressors is important.

Music therapy is a known intervention linked with improved outcomes in women undergoing procedural interventions, including labor and delivery. Art therapy is also associated with improved outcomes, though outside of obstetrics. In elderly women with depression and those with breast cancer diagnoses, visual art therapy has been shown to be superior to other non-medicinal interventions in improving mood. Current data is both qualitative as well as quantitative, demonstrating positive impacts on patients.

While evidence exists to support the utilization of these alternative forms of therapy, they have not been adequately applied to pregnant and postpartum women outside of music therapy. With the understanding that other art forms are tied with improvement in anxiety, depression, and quality of life, the implementation in this special patient population is paramount. Investigating how a relatively benign intervention can possibly promote improvement in maternal mental health, thus allowing for better mother-baby bonding in the first year of life, is key in finding ways to support the growth and development of healthy families.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Participants will have to be eighteen years of age or older
  • •in the second trimester of pregnancy at time of recruitment
  • •speak and read English as their primary language
  • •have access to a reliable internet/wifi connection to participate in therapy sessions
  • •plan to deliver at Washington Hospital Center

排除标准

  • •- Women who do not meet those criteria

研究组 & 干预措施

Intervention

Experimental

Engage in six art therapy sessions

干预措施: art therapy (Other)

Control

Placebo Comparator

Engage in usual activities

干预措施: nothing (Other)

结局指标

主要结局

utilization of behavioral health/psychology/psychiatry services during pregnancy and postpartum

时间窗: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum

chart review to see if patients utilized services "yes" vs. "no"

use of psychiatry medications during and after pregnancy

时间窗: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum

chart review to see if patients utilized services "yes" vs. "no"

changes in Edinburgh Postnatal Depression Scale scores

时间窗: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum

raw score on scale

change in maternal-infant bonding scores

时间窗: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum

raw score on scale

次要结局

  • NICU admissions(delivery)
  • gestational age at time of delivery(delivery)
  • obstetrical complications (postpartum hemorrhage, OASIS, ICU admission)(up to 3 months postpartum)
  • mode of delivery(delivery)
  • birth weight(delivery)
  • APGAR scores(delivery)
  • delivery complications (shoulder dystocia, low birth weight)(delivery)
  • reason for delivery (iatrogenic vs spontaneous)(delivery)

研究者

发起方
Medstar Health Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara N. Iqbal

Primary Investigator

Medstar Health Research Institute

研究点 (1)

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