The Effect of Breastfeeding Support Provided Via Video-conferencing

The Effect of Breastfeeding Support Provided Via Video-conferencing on Postpartum Anxiety, Breastfeeding Self-Efficacy and Neonatal Outcomes: A Randomized Controlled Trial

A randomized control trial was made to examine the effects of breastfeeding support given by the video-conferencing method in the early postpartum period on anxiety, breastfeeding self-efficiency, and newborn outcomes.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Disorders; Breastfeeding; Neonatal Outcomes
• Intervention / Treatment: Behavioral: Video-conferencing group

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deniz Akyıldız, PhD; Phone Number: 05069851358; Email: denizbtm@gmail.com
• Study Contact Backup: Name: Deniz Akyıldız; Phone Number: 05069851358; Email: denizbtm@gmail.com

Study Locations

• Turkey
  • Kahramanmaraş
    • Kahramanmaras, Kahramanmaraş, Turkey, 4600
      • Recruiting
      • Kahramanmaraş Sütçü İmam University
      • Contact: Deniz Akyıldız; Phone Number: 05069851358; Email: denizbtm@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Infants;

• Born between 37 and 42 weeks
• Without severe congenital anomalies

Mothers;

• A single live birth
• Were 18 years of age or over
• At least primary school graduate
• Did not have a disease that prevents breastfeeding
• Had internet access at home or on the phone
• Could speak and understand the Turkish language.

Exclusion Criteria:

• Situations that cause separation of mother and baby
• Hospitalization of the baby in intensive care
• Inability to answer 3 calls in a video call
• They were determined as those who could not be reached during the home visit for the first and second follow

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video-conferencing group; The mothers in the video-conferencing group were counseled via video-conferencing a total of six times (three times a week, at equal intervals) during the first 2 weeks after birth. Each interview was approximately 15-20 minutes. In video-conferencing sessions, the breastfeeding position, the mother's grasping the breast, the baby's latch-on, and sucking duration were observed. Mothers' questions were answered and solutions were offered for breastfeeding problems (sore nipple, engorgement, etc.).	Behavioral: Video-conferencing group; No intervention; Other Names: Control group
No Intervention: Control group; The mothers in the control group were given usual care before discharge and no intervention was made after discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean postpartum maternal anxiety level (mean ± SD)	The primary outcome of this study was the mean postpartum maternal anxiety level (mean ± SD) of the mothers at 2 weeks and 4 weeks after delivery. Maternal anxiety level was assessed using the Postpartum Specific Anxiety Scale. The scale comprises 51 items and 4 sub-dimensions. It means that those who score 73 and below on the scale have low postpartum anxiety levels, those who score between 74 and 100 have a medium level, and those who score 101 and above have a high level of anxiety.	at 2 weeks and 4 weeks after delivery
The mean breastfeeding self-efficacy level	The other main outcome of the study was the mean breastfeeding self-efficacy level (mean ± SD) measured with the Breastfeeding Self-Efficacy Scale Short Form. The scale is likert type and a total score between 14 and 70 is taken from the scale. The higher the score, the higher the breastfeeding self-efficacy.	at 2 weeks and 4 weeks after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal outcomes-Newborn weight (g)	Newborn weight (g) was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery	at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Hypoglycemia of the newborn	Hypoglycemia of the newborn was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery.	at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Need for phototherapy	The need for phototherapy was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery	at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Respiratory morbidity	Respiratory morbidity was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery	at 2 weeks and 4 weeks after delivery
Neonatal outcomes-illness requiring hospitalization	Illness requiring hospitalization was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery	at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Food intake other than breast milk	Food intake other than breast milk was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery	at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Neonatal death	Neonatal death was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery	at 2 weeks and 4 weeks after delivery

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University
• Investigators: Principal Investigator: Betül Bay, Kahramanmaraş Sütçü İmam University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Breastfeeding Support

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No