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Clinical Trials/NCT04929561
NCT04929561
Unknown
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The Effect of Breastfeeding Support Provided Via Video-conferencing on Postpartum Anxiety, Breastfeeding Self-Efficacy and Neonatal Outcomes: A Randomized Controlled Trial

Kahramanmaras Sutcu Imam University1 site in 1 country78 target enrollmentAugust 25, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breastfeeding
Sponsor
Kahramanmaras Sutcu Imam University
Enrollment
78
Locations
1
Primary Endpoint
The mean postpartum maternal anxiety level (mean ± SD)
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 25, 2020
End Date
September 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kahramanmaras Sutcu Imam University
Responsible Party
Principal Investigator
Principal Investigator

Deniz Akyıldız

Assistant Professor

Kahramanmaras Sutcu Imam University

Eligibility Criteria

Inclusion Criteria

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

Outcomes

Primary Outcomes

The mean postpartum maternal anxiety level (mean ± SD)

Time Frame: at 2 weeks and 4 weeks after delivery

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.

The mean breastfeeding self-efficacy level

Time Frame: at 2 weeks and 4 weeks after delivery

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.

Secondary Outcomes

  • Neonatal outcomes-Newborn weight (g)(at 2 weeks and 4 weeks after delivery)
  • Neonatal outcomes-Hypoglycemia of the newborn(at 2 weeks and 4 weeks after delivery)
  • Neonatal outcomes-Need for phototherapy(at 2 weeks and 4 weeks after delivery)
  • Neonatal outcomes-Respiratory morbidity(at 2 weeks and 4 weeks after delivery)
  • Neonatal outcomes-illness requiring hospitalization(at 2 weeks and 4 weeks after delivery)
  • Neonatal outcomes-Food intake other than breast milk(at 2 weeks and 4 weeks after delivery)
  • Neonatal outcomes-Neonatal death(at 2 weeks and 4 weeks after delivery)

Study Sites (1)

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