NCT05441033

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2023

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

June 22, 2022

Last Update Submit

April 2, 2025

Conditions

Keywords

Fetal Heart Rate SoundsGuided ImageryPrenatal AttachmentAnxiety, PregnancySleep Quality

Outcome Measures

Primary Outcomes (4)

  • The Maternal Antenatal Attachment Scale

    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).

    Change in Prenatal Attachment Levels of Expectant Mothers over 4 Days

  • The Paternal Antenatal Attachment Scale

    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.

    Change in Prenatal Attachment Levels of Expectant Fathers over 4 Days

  • Richard Campbell Sleep Questionnaire

    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.

    Change in Couples Sleep Quality over 4 Days

  • State Anxiety Inventory

    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.

    Change in Couples State Anxiety over 4 Days

Study Arms (3)

Group-FHS

EXPERIMENTAL

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.

Other: Fetal Heart Sounds (FHS) Listening Intervention

Group-GIT

EXPERIMENTAL

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.

Other: Guided Imagery Technique (GIT) Intervention

Control Group

NO INTERVENTION

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.

Interventions

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.

Group-FHS

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.

Group-GIT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Science

Malatya, 44000, Turkey (Türkiye)

Location

Related Publications (1)

  • Benli TE, Aksoy Derya Y. Turkish validity and reliability study of Paternal Antenatal Attachment Scale. Perspect Psychiatr Care. 2021 Jan;57(1):295-303. doi: 10.1111/ppc.12563. Epub 2020 Jun 21.

    PMID: 32567046BACKGROUND

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersAnxiety Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Tuba Enise Benli, Phd

    Giresun University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking was applied. Both participants and researchers were aware of the assigned interventions.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with three parallel arms: fetal heart sounds group (FHS), guided imagery technique group (GIT), and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 1, 2022

Study Start

April 22, 2022

Primary Completion

December 1, 2022

Study Completion

July 14, 2023

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data (IPD) with other researchers. The reason is that the institution where the study was conducted does not permit the distribution of individual-level data due to confidentiality policies.

Locations