- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05441033
The Effects of Angel Sounds and Guided Imagery Technique Played to Expectant Couples
The Effects of Angel Sounds and Guided Imagery Technique Played to Expectant Couples on Attachment, Anxiety and Sleep Quality
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Malatya, Turkey, 44000
- Faculty of Health Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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. -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group-FHS
Couples provided written and verbal consent after being informed about the study. Pre-test data were collected using the Personal Information Forms (PIF-Female, PIF-Male), Antenatal Mother Attachment Scale (PAAS), Antenatal Father Attachment Scale (PAAS), the Richard Campbell Sleep Questionnaire (RCSQ), and the State Anxiety Inventory (SAI). Couples listened to fetal heart sounds (angel sounds) each night before sleep for three consecutive nights, with each session lasting approximately 20 minutes. The researcher provided remote support via WhatsApp throughout the intervention period. Post-test data were collected on the fourth day using the same measurement tools. |
Pregnant women and their partners listened to fetal heart sounds (also referred to as angel sounds) for 20 minutes before bedtime on three consecutive nights using a fetal heart rate monitoring device.
The intervention aimed to enhance prenatal attachment and reduce anxiety by increasing awareness of the fetus through auditory stimulation.
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Experimental: Group-GIT
Couples provided written and verbal consent after being informed about the study. Pre-test data were collected using the same tools as the FHS group. Couples were sent audio recordings prepared using guided imagery scripts, and instructed to listen each night before sleep for three consecutive nights. The audio included calming suggestions to promote attachment and reduce anxiety. On the fourth day, post-test data were collected using the same tools. |
Pregnant women and their partners listened to guided imagery audio recordings for 20 minutes before bedtime on three consecutive nights.
The recordings were developed to support bonding with the baby, reduce anxiety, and improve sleep quality.
The intervention was delivered via audio files prepared by the research team based on structured imagery scripts.
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No Intervention: Control Group
Couples in the control group received no intervention.
Pre-test data were collected using the same measurement tools as the experimental groups.
After three days without intervention, post-test data were collected on the fourth day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Maternal Antenatal Attachment Scale
Time Frame: Change in Prenatal Attachment Levels of Expectant Mothers over 4 Days
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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).
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Change in Prenatal Attachment Levels of Expectant Mothers over 4 Days
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The Paternal Antenatal Attachment Scale
Time Frame: Change in Prenatal Attachment Levels of Expectant Fathers over 4 Days
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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.
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Change in Prenatal Attachment Levels of Expectant Fathers over 4 Days
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Richard Campbell Sleep Questionnaire
Time Frame: Change in Couples Sleep Quality over 4 Days
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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.
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Change in Couples Sleep Quality over 4 Days
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State Anxiety Inventory
Time Frame: Change in Couples State Anxiety over 4 Days
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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.
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Change in Couples State Anxiety over 4 Days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tuba Enise Benli, Phd, Giresun University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/2570
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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