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临床试验/NCT06279559
NCT06279559招募中不适用

Evaluating the Impact of Music Therapy on Psychological Well-being During High-risk Pregnancy

Istituto Giannina Gaslini2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年6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
招募中
入组人数
72
试验地点
2
主要终点
Perceived positive and negative feelings

研究概览

简要总结

The objective of this clinical trial is to assess the impact of a music therapy intervention on reactive psychological components related to the risk of preterm birth in hospitalized pregnant women. The primary inquiries it seeks to address are:

  1. Can a music therapy intervention during high-risk pregnancy mitigate reactive psychological components (perceived emotional state, state anxiety and trait anxiety, depressive symptoms, perceived stress) related to the risk of preterm birth in hospitalized pregnant women?
  2. Does music therapy intervention during high-risk pregnancy positively influence the development of the attachment bond between the mother and the child?
  3. How does the risk of preterm birth modulate the future attachment bond between mother and child?

Participants will be categorized into three groups: a clinical experimental group (pregnant women at risk of preterm birth undergoing music therapy intervention), a clinical control group (pregnant women at risk of preterm birth receiving standard ward care), and a non-clinical control group (pregnant women with a physiologically progressing pregnancy).

Upon signing the informed consent, all three groups will be required to complete five self-report questionnaires assessing perceived positive and negative feelings, depressive symptoms, state anxiety and trait anxiety, perceived stress, and the mother-fetus attachment bond. Subsequently, the clinical experimental group will undergo ten online music therapy sessions, while the clinical control group will receive routine ward care. Following the music therapy sessions, both clinical groups will reassess the aforementioned measures. The non-clinical control group will complete the same self-report questionnaires with the same timing as the clinical groups. All three groups will be contacted three months after childbirth to complete a self-report questionnaire evaluating the postnatal attachment bond.

Researchers will compare the outcomes of the two clinical groups to address the first two research questions, while the comparison between the clinical control group and the non-clinical control group outcomes will be employed to answer the third research question.

详细描述

Background and Rationale Every year, approximately 15 million children are born prematurely worldwide, with a global incidence of around 11%. Preterm birth occurs when labor takes place between the 22nd and 37th completed weeks of gestation, representing a significant public health concern. Preterm birth is associated with higher rates of infant morbidity and mortality, increased risk of long-term medical complications, impaired neurological development, family stress, and substantial social costs. Conversely, the risk of preterm birth is a stressful event for caregivers, particularly for pregnant women, potentially evolving into a traumatic experience, eliciting feelings of anxiety and depression. In cases of preterm birth risk, the initial phase of parenthood is marked by uncertainty, dominated by prevalent emotional correlates of anxiety and fear of death, which, in turn, diminish the psychological investment in the child. Many parents respond to this reality with an initial phase of rejection and ambivalence towards the child, expressing both frustration and common concerns about the infant's survival.

The risk of preterm birth falls under high-risk pregnancies, defined as "[...] any unexpected or unforeseen medical or obstetric condition associated with pregnancy with an actual or potential risk to the health or well-being of the mother or fetus...". Compared to women with low-risk pregnancies, those with high-risk pregnancies exhibit significantly higher levels of stress and anxiety, report more negative emotions when facing stress, and have a worse emotional state. Additionally, women confined due to high-risk pregnancies show predominant emotional responses of fear, anxiety, and emotional distance from the child, along with depressive symptoms and feelings of loneliness. Thus, the emotional impact of the risk of preterm birth on pregnant women demands adequate clinical attention, particularly considering that the reactive symptoms mentioned above serve as predictive factors when exploring the psychosocial determinants of preterm birth.

Furthermore, the risk of preterm birth can negatively influence the development of the mother-fetus attachment bond (or prenatal attachment), although some studies report contrasting results. Prenatal attachment, derived from John Bowlby's Attachment Theory, is defined as "the emotional bond that normally develops between the pregnant parent and their unborn child". It serves as an early indicator of the future quality of the mother-child attachment bond and is a crucial factor influencing the child's subsequent well-being. Women with high-risk pregnancies may experience guilt for their condition, and the risk of preterm birth and premature rupture of membranes can interrupt the psychological preparation process for motherhood. Negative thoughts in pregnant women related to fetal health and the possibility of fetal death can evoke fear of developing a relationship with the fetus, hindering attachment development.

Therefore, it becomes crucial to identify effective, non-invasive, and adaptable methods within the hospital setting to reduce unpleasant emotional states in pregnant women at risk of preterm birth and promote the structuring of the attachment bond. In this context, recent research has increasingly focused on music therapy as one of the potential approaches to alleviate emotional states linked to pregnancy.

The World Federation of Music Therapy defines music therapy as "[...] the professional use of music and its elements as an intervention in medical, educational, and social environments with individuals, groups, families, or communities seeking to optimize their quality of life and improve physical, social, communicative, emotional, intellectual, and spiritual health". Recent literature reviews and meta-analytical studies have documented how music therapy can be effective in reducing stress-related symptoms (both in medical and mental health contexts), decreasing depressive symptoms, and anxious symptoms. Regarding its use during pregnancy, music therapy, besides significantly reducing mental health problems such as anxiety, depressive symptoms, and perceived stress in pregnant women, can address the sensory, physical, and emotional needs of pregnant women and support the process of creating the attachment bond, promoting the development of meaningful interactions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

clinical experimental group

Experimental

pregnant women with the risk of preterm birth who will undergo music therapy intervention

干预措施: Music-therapy (Behavioral)

clinical control group and non-clinical control group

No Intervention

pregnant women with the risk of preterm birth who will receive the usual ward care and pregnant women with pregnancy with a physiological course

结局指标

主要结局

Perceived positive and negative feelings

时间窗: administered before and within one week after the conclusion of the music therapy intervention

Positive and Negative affect Schedule (PANAS)

Perceived stress

时间窗: administered before and within one week after the conclusion of the music therapy intervention

Perceived Stress Scale (PSS)

Mother-fetus attachment bond

时间窗: administered before and within one week after the conclusion of the music therapy intervention

Maternal Antenatal Attachment Scale (MAAS)

Depressive symptoms

时间窗: administered before and within one week after the conclusion of the music therapy intervention

Edimburg Prenatal Depression Scale (EPDS)

State anxiety and trait anxiety

时间窗: administered before and within one week after the conclusion of the music therapy intervention

State-Trait Anxiety Inventory - Forma Y (STAI-Y)

Mother-child attachment bond

时间窗: administered three months after the childbirth

Postpartum Attachment Scale (MPAS)

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

Cristina Venturino

Dr

Istituto Giannina Gaslini

研究点 (2)

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