Clinical trial NCT05441033: The Effects of Angel Sounds and Guided Imagery Technique Played to Expectant Couples
Official title: The Effects of Angel Sounds and Guided Imagery Technique Played to Expectant Couples on Attachment, Anxiety and Sleep Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Anxiety
Prenatal Attachment
Sleep Quality
Keywords: Fetal Heart Rate Sounds
Guided Imagery
Prenatal Attachment
Anxiety, Pregnancy
Sleep Quality
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with three parallel arms: fetal heart sounds group (FHS), guided imagery technique group (GIT), and control group.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: The Maternal Antenatal Attachment Scale
timeFrame: Change in Prenatal Attachment Levels of Expectant Mothers over 4 Days
measure: The Paternal Antenatal Attachment Scale
timeFrame: Change in Prenatal Attachment Levels of Expectant Fathers over 4 Days
measure: Richard Campbell Sleep Questionnaire
timeFrame: Change in Couples Sleep Quality over 4 Days
measure: State Anxiety Inventory
timeFrame: Change in Couples State Anxiety over 4 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Faculty of Health Science
Study officials:
affiliation: Giresun University
name: Tuba Enise Benli, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.