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临床试验/NCT05441033
NCT05441033已完成不适用

The Effects of Angel Sounds and Guided Imagery Technique Played to Expectant Couples on Attachment, Anxiety and Sleep Quality

Inonu University2 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2022年4月22日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
354
试验地点
2
主要终点
The Maternal Antenatal Attachment Scale

研究概览

简要总结

The study sample consisted of 177 pregnant women and their partners who met the inclusion criteria and participated in a prenatal education class. Expectant couples were randomized into three groups: Group 1 (FHS) listened to fetal heartbeat sounds, Group 2 (GIT) received the guided imagery intervention, and Group 3 served as the control group. Each group consisted of 59 couples.

详细描述

Aim: This randomized controlled trial aimed to evaluate the effects of listening to angel sounds (fetal heartbeat) and applying the guided imagery technique on prenatal attachment, anxiety, and sleep quality among expectant couples.

Methods: The study included 177 pregnant women and their partners who attended a prenatal education class and met the inclusion criteria. Expectant couples were randomly assigned into three equal groups. In Group 1 (FHS), only fetal heartbeat sounds were listened to. In Group 2 (GIT), the guided imagery technique was applied. Group 3 served as the control group. Each group consisted of 59 couples.

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

盲法说明

No masking was applied. Both participants and researchers were aware of the assigned interventions.

入排标准

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

入选标准

  • Having basic literacy skills,
  • Owning a smartphone and having internet access,
  • Having a singleton and viable pregnancy,
  • Being between the 27th and 38th weeks of gestation,
  • Not having any diagnosed pregnancy-related risks (e.g., preeclampsia, diabetes, placenta previa, oligohydramnios),
  • Not having any diagnosed fetal health issues (e.g., fetal anomalies, intrauterine growth restriction),
  • Pregnant individuals and their spouses with no current or prior psychiatric diagnoses.

排除标准

  • Not living with their spouse,
  • Spouse working in shifts,
  • Pregnancy via assisted reproductive techniques,
  • Currently participating in childbirth education programs,
  • Presence of communication difficulties or cognitive impairments in either the pregnant individual or the spouse.
  • Withdrawal Criteria:
  • Participated in the intervention for fewer than 3 nights,
  • Unable to use the Fetal Heart Rate Monitoring Device (FHRMD),
  • Experiencing premature birth or pregnancy loss,
  • Incomplete questionnaire data,
  • Voluntary withdrawal from the study by the participant or their spouse. -

结局指标

主要结局

The Maternal Antenatal Attachment Scale

时间窗: Change in Prenatal Attachment Levels of Expectant Mothers over 4 Days

Each item of The Maternal Antenatal Attachment Scale (MAAS), which has a total of 19 items, focuses on the pregnant woman's feelings, attitudes and behaviors towards the fetus. The scale is likert-type and each item is scored between 1 and 5 (5=represents very strong feelings towards the fetus; 1=represents the absence of feelings towards the fetus). A high score indicates a high degree of attachment. 11 items in the scale are scored in the opposite direction (1, 3, 5, 6, 7, 9, 10, 12, 15, 16, 18).

The Paternal Antenatal Attachment Scale

时间窗: Change in Prenatal Attachment Levels of Expectant Fathers over 4 Days

The Paternal Antenatal Attachment Scale are based on the fathers' experiences in the last two weeks and measure the father's feelings and thoughts towards the developing fetus in the mother's womb. Increasing score indicates higher degree of attachment. The scale is in 5-point Likert type and consists of 16 items and two sub-dimensions. Sub dimensions; "quality of attachment \[2, (3), (7), 9, 11, (12), (15), 16\]" in which the emotional experience of the father is measured while thinking about the baby in the womb, "time spent on attachment \[( 1), 4, (5), (6), (8), 10, (13), 14\]". 9 items are reverse scored in the scale. Cronbach's alpha reliability coefficient of the scale was 0.82; the Cronbach's alpha of the quality of attachment sub-dimension was 0.80; The alpha of the time spent connecting sub-dimension is 0.67.

Richard Campbell Sleep Questionnaire

时间窗: Change in Couples Sleep Quality over 4 Days

This scale is a 6-item scale that measures the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment. Each of the items is evaluated on a chart with numbers from 0 to 100. According to the scale scoring, "0-25" points indicate very bad sleep, while "76-100" points indicate very good sleep. The 6th item, which evaluates the noise level in the environment, is excluded from the scale total score evaluation, and the total score is evaluated over 5 items. As the score of the scale increases, the sleep quality of the patients also increases. The scale's Cronbach α value is 0.91.

State Anxiety Inventory

时间窗: Change in Couples State Anxiety over 4 Days

The scale is a self-evaluation type scale consisting of short statements. It is used to determine how an individual feels in a certain situation and in a certain area. The emotions or behaviors expressed in the State Anxiety Scale items are answered by marking one of the options such as (1) not at all, (2) a little, (3) a lot, (4) completely, depending on the severity of the emotion or behavior. There are two types of expressions in the scale. These are reversed or straight forward expressions. reversed expressions; positive feelings express, direct expressions express negative feelings. When scoring reverse expressions, those with a weight of 1 are converted to 4, and those with a weight of 4 are converted to 1. In the State Anxiety Scale; There are ten reversed statements, items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. When scoring, the reversed and direct statements are summed.

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

Tuba Enise BENLI

Principal Investigator

Inonu University

研究点 (2)

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