The Effect of Visual and Audio Stimulus Offered to Father-to-be

NCT06282419 | Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/542
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasonography Prenatal

Outcome Measures

Primary Outcomes (8)

• Introductory Information Form (For Women)

  The introductory information form prepared by the researchers consists of 16 questions about the introductory characteristics of women.

  30 days after birth

• Spouse Support Scale Perceived by Women During Early Postpartum Period

  The sub-dimensions are named "emotional support" (7 items), "social support" (6 items) and "physical support" (3 items). In the items, 1 was taken as "strongly disagree", 2 as "disagree", 3 as "undecided", 4 as "agree", and 5 as "strongly agree". In negative question items, 1 was taken as "strongly agree", 2 as "agree", 3 as "undecided", 4 as "disagree", and 5 as "strongly disagree".

  30 days after birth

• Breastfeeding Self-Efficacy Scale-Short Form

  This scale, which consists of a total of 14 items, is a 5-point Likert type and is evaluated as not at all sure (1 point) and always sure (5 points). The lowest score that can be obtained from the scale is 14 and the highest score is 70. The scale has no cut-off point; a higher score means higher breastfeeding self-efficacy.

  30 days after birth

• Breastfeeding Adaptation Scale

  The scale consists of 8 sub-dimensions and 27 items. Scale items are rated on a 5-point Likert scale between 1 point and 5 points (1 point: Strongly disagree, 2 points: Disagree, 3 points: Undecided, 4 points: Agree, 5 points: Strongly agree). Three items in the 6th sub-dimension of the scale, "Discomfort in Breastfeeding", contain negative statements and are rated as 1 (strongly agree) and 5 (strongly disagree). The minimum score that can be obtained from the scale is 27 and the maximum score is 135.

  30 days after birth

• Edinburgh Postpartum Depression Scale

  It is a self-evaluation scale consisting of 10 items in four-point Likert format. Responses consisting of four options are scored between 0 and 3, the lowest score that can be obtained from the scale is 0 and the highest score is 30. The cut-off point of EPDS is calculated as 12/13, and women whose total scale score is higher than the cut-off point are considered to be in the risk group.

  30 days after birth

• Introductory Information Form (For Men)

  The introductory information form prepared by the researchers consists of 5 questions about the personal characteristics of men.

  30 days after birth

• Fathers' Breastfeeding Attitude and Participation Scale

  It consists of a total of 28 items. In this scale, responses are evaluated on a five-point Likert scale: "1 = Strongly disagree", "2 = Disagree", "3 = Undecided", "4 = Agree" and "5 = Strongly agree". The total score to be obtained from the BET subscale varies between 14-70 and the cut-off point of the scale is 58. Those with a total score of ≥58 are considered positive attitudes, and those \<58 are considered negative attitudes. The total score to be obtained from the BEK subscale varies between 14-70 and the cut-off point of the scale is 58. Those with a total score of ≥58 are called good participation, and those with \<58 are called poor participation.

  30 days after birth

• Edinburgh Postpartum Depression Scale for Men

  It is a self-evaluation scale consisting of 10 items in four-point Likert format. Responses consisting of four options are scored between 0 and 3, the lowest score that can be obtained from the scale is 0 and the highest score is 30. The cut-off point of EPDS is calculated as 9/10, and men whose total scale score is higher than the cut-off point are considered to be in the risk group.

  30 days after birth

Study Arms (3)

Experimental group 1

EXPERIMENTAL

Fetal images and fetal heart sound recordings will be taken 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 will be sent to the prospective fathers in experimental group 1 by the researcher via WhatsApp application twice a week until birth (at least 3 weeks).

Other: USE OF MOBILE ULTRASOUND

Experimental group 2

PLACEBO COMPARATOR

Fetal USG images and fetal heart sounds taken from the internet, which are not of their babies, will be sent to the prospective fathers by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). In the second stage of the research; Breastfeeding videos prepared by the researcher will be sent to fathers in experimental group 2 twice a week for 4 weeks after birth via WhatsApp application.

Other: ultrasound image taken from the internet

control group

NO INTERVENTION

No visual or auditory stimuli were sent.

Interventions

USE OF MOBILE ULTRASOUND OTHER

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 will be applied to the women and expectant fathers assigned to the experimental and control groups through face-to-face interview technique. Then, fetal images and fetal heart sounds will be recorded from the pregnant women in experimental group 1 with a mobile phone compatible portable USG device. Fetal USG images and fetal heart sounds taken with the portable USG device of their babies will be sent to the prospective fathers in experimental group 1 by the researcher via WhatsApp application twice a week until birth (at least 3 weeks). In the second stage of the research; Breastfeeding videos prepared by the researcher will be sent to fathers via WhatsApp twice a week for 4 weeks after birth.

Experimental group 1

ultrasound image taken from the internet OTHER

First stage; Fetal USG images and fetal heart sounds, not belonging to their babies, taken from the internet, will be sent to the fathers in experimental group 2 via WhatsApp application by the researcher twice a week until birth (at least 3 weeks). In the second stage of the research; Breastfeeding videos prepared by the researcher will be sent to fathers via WhatsApp application twice a week for 4 weeks after birth.

Experimental group 2

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being literate
• Being nulliparous
• 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
• 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

You may not qualify if:

• Criteria for excluding pregnant women from the study:
• Illiteracy
• Having a high risk pregnancy
• Having a diagnosed psychiatric disease
• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University

Erzurum, Turkey (Türkiye)

RECRUITING

Study Officials

• Ayla KANBUR

  Ataturk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

merve Çakıl

CONTACT

+905310854245; mervecakil92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist midwife

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 28, 2024
• Study Start: August 21, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)