Clinical trial NCT06282419: The Effect of Visual and Audio Stimulus Offered to Father-to-be
Official title: The Effect of Visual and Auditory Stimuli Presented to Expectant Fathers on Mothers' Postpartum Breastfeeding Success, Perception of Partner Support and Postpartum Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ultrasonography Prenatal
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a study that evaluates the effects on mothers by involving fathers in the pregnancy follow-up process through the use of mobile ultrasound.
Primary purpose: SUPPORTIVE_CARE

Brief summary: It was aimed to evaluate the effect of visual and auditory stimuli presented to father candidates on postpartum breastfeeding success of mothers, perception of spousal support and postpartum depression. The study, which was carried out in a randomized controlled experimental design, consists of nulliparous pregnant women and their spouses who came to the relevant health center for prenatal control between May 2023 and May 2024. In the study, 132 pregnant women (Experimental group 1:44, Experimental group 2:44, control group:44) were recruited with a priori power analysis. In the study, women and their spouses were assigned to the experimental and control groups by randomization. For randomization, single-group columns between 1-165 were created in the system using the Random Integer Generator method in the Numbers subheading of the random.org website. Considering the numbers 1, 2 and 3 in the column, nulliparous pregnant women coming to the polyclinic were randomly assigned to these numbers. Which numbers constitute which group was determined by drawing lots at the beginning of the research. In data collection, Introductory Information Form for women, Women's Perceived Spousal Support Scale in Early Postpartum Process, Breastfeeding Self-Efficacy Scale-Short Form, Breastfeeding Adaptation Scale and Edinburgh Postpartum Depression Scale; Introductory Information Form for men, Fathers; Breastfeeding Attitude and Participation Scale and Edinburgh Postpartum Depression Scale (for Men) were used. Data; It was evaluated in the SPSS program.

Detailed description: Data were collected by the researcher. The research was conducted in 2 stages. First stage; Women and their partners who meet the research criteria are at the 32-35th week of pregnancy. was included in the study during the week. First, introductory information forms were applied to the women and expectant fathers assigned to the experimental and control groups using the face-to-face interview technique.

Then, fetal images and fetal heart sounds were recorded from the pregnant women in experimental group 1 with a mobile phone compatible portable USG device. Fetal USG images of their babies, taken with a portable USG device, and fetal heart sounds were sent to the expectant fathers in experimental group 1 by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). To the prospective fathers in experimental group 2, fetal USG images and fetal heart sounds taken from the internet, which were not of their babies, were sent by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). At this stage, no intervention was made to the fathers in the control group.

In the second stage of the research; Breastfeeding videos prepared by the researcher were sent to the fathers in experimental groups 1 and 2 via WhatsApp application twice a week for 4 weeks after birth. At this stage, no intervention was made to the fathers in the control group.

At the end of the 4th postpartum week, the women in the experimental groups and the control group were given the Spouse Support Scale Perceived by Women in the Early Postpartum Process, Breastfeeding Self-Efficacy Scale-Short Form, Breastfeeding Adaptation Scale and Edinburgh Postpartum Depression Scale by preparing a Google survey and sending the survey link via WhatsApp application. were provided to fill out.

Likewise, at the end of the 4th postpartum week, the fathers in the experimental groups and the control group were asked to fill out the Fathers; Breastfeeding Attitude and Participation Scale and the Edinburgh Postpartum Depression Scale via a Google survey, and the survey link was sent via WhatsApp application.

Taking USG images: They were taken and recorded by the researcher with a portable USG device. The researcher received a certificate by attending the midwife USG usage course.

Taking fetal heart sounds: They were taken and recorded by the researcher with a portable USG device.

Videos on breastfeeding: Prepared by the research team.

Eligibility criteria: Inclusion Criteria:

Criteria for inclusion of pregnant women in the study:

* Being literate
* Being nulliparous
* 32-35. weeks of pregnancy between
* Having a single fetus
* There is no obstacle to vaginal birth
* There is no condition that prevents breastfeeding
* Being open to communication
* Volunteering to participate in the research

Criteria for inclusion of fathers in the study:

* Being literate
* Being over 18 years of age
* Being a father for the first time
* Using a smartphone
* Being open to communication
* Volunteering to participate in the research

Exclusion Criteria:

* Criteria for excluding pregnant women from the study:

  * Illiteracy
  * Having a high risk pregnancy
  * Having a diagnosed psychiatric disease

Exclusion criteria for women in the postpartum period from the study:

* Having given birth prematurely
* Having had a caesarean section
* Development of complications in the mother and/or baby after birth
* A condition that prevents breastfeeding in the mother and/or baby

Criteria for not including fathers in the study:

* Illiteracy
* Being under 18 years of age
* Having a diagnosed psychiatric disease

Primary outcomes:
measure: Introductory Information Form (For Women)
timeFrame: 30 days after birth
measure: Spouse Support Scale Perceived by Women During Early Postpartum Period
timeFrame: 30 days after birth
measure: Breastfeeding Self-Efficacy Scale-Short Form
timeFrame: 30 days after birth
measure: Breastfeeding Adaptation Scale
timeFrame: 30 days after birth
measure: Edinburgh Postpartum Depression Scale
timeFrame: 30 days after birth
measure: Introductory Information Form (For Men)
timeFrame: 30 days after birth
measure: Fathers' Breastfeeding Attitude and Participation Scale
timeFrame: 30 days after birth
measure: Edinburgh Postpartum Depression Scale for Men
timeFrame: 30 days after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University
Study officials:
affiliation: Ataturk University
name: Ayla KANBUR
role: PRINCIPAL_INVESTIGATOR
References: