Prenatal AnxietyNCT05441033
The Effects of Angel Sounds and Guided Imagery Technique Played to Expectant Couples
A study testing Fetal Heart Sounds (FHS) Listening Intervention and Guided Imagery Technique (GIT) Intervention in people with Prenatal Anxiety and Prenatal Attachment, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prenatal Anxiety, Prenatal Attachment, Sleep Quality
- What is being tested?
- Fetal Heart Sounds (FHS) Listening Intervention and Guided Imagery Technique (GIT) Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2022to 14 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 11Show fewer
- 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. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Angel Sounds and Guided Imagery Technique Played to Expectant Couples on Attachment, Anxiety and Sleep Quality
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.
Read the 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.
- Conditions
- Prenatal Anxiety, Prenatal Attachment, Sleep Quality
- Being tested
- Fetal Heart Sounds (FHS) Listening Intervention, Guided Imagery Technique (GIT) Intervention
- Keywords
- Fetal Heart Rate Sounds, Guided Imagery, Prenatal Attachment, Anxiety, Pregnancy, Sleep Quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Heart Sounds (FHS) Listening InterventionOther
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.
Guided Imagery Technique (GIT) InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change in Couples State Anxiety over 4 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start22 Apr 2022
- Primary completion1 Dec 2022
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prenatal AnxietyStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with three parallel arms: fetal heart sounds group (FHS), guided imagery technique group (GIT), and control group.
- Masking
- None (open label)
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Enise BENLI, Inonu University
- Investigators
- Tuba Enise Benli, Phd, Principal investigator, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441033
- Sponsor's protocol ID
- 2021/2570
- Status last verified
- Apr 2025
- First submitted
- 22 Jun 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32567046
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Angel Sounds and Guided Imagery Technique Played to Expectant Couples on Attachment, Anxiety and Sleep Quality
- ClinicalTrials.gov ID
- NCT05441033
- Acronym / sponsor ID
- 2021/2570
- Conditions
- Prenatal Anxiety, Prenatal Attachment, Sleep Quality
- Keywords
- Fetal Heart Rate Sounds, Guided Imagery, Prenatal Attachment, Anxiety, Pregnancy, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled trial with three parallel arms: fetal heart sounds group (FHS), guided imagery technique group (GIT), and control group.
| Arm | Type | Receives |
|---|---|---|
| Group-FHS | Experimental | Other: Fetal Heart Sounds (FHS) Listening InterventionCouples 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. |
| Group-GIT | Experimental | Other: Guided Imagery Technique (GIT) InterventionCouples 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal Heart Sounds (FHS) Listening InterventionPregnant 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. | Other | Group-FHS |
| Guided Imagery Technique (GIT) InterventionPregnant 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. | Other | Group-GIT |
Primary outcome
The Maternal Antenatal Attachment Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 32567046Benli 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuba Enise Benli, Phd principal investigator
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal Heart Sounds (FHS) Listening Intervention and Guided Imagery Technique (GIT) Intervention in people with Prenatal Anxiety and Prenatal Attachment, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Maternal Antenatal Attachment Scale (time frame: Change in Prenatal Attachment Levels of Expectant Mothers over 4 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05441033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.