The Effect of Breastfeeding Support Provided Via Video-conferencing

Sponsor
Kahramanmaras Sutcu Imam University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04929561
Collaborator
(none)
78
1
2
13.2
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Video-conferencing group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Breastfeeding Support Provided Via Video-conferencing on Postpartum Anxiety, Breastfeeding Self-Efficacy and Neonatal Outcomes: A Randomized Controlled Trial
Actual Study Start Date :
Aug 25, 2020
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. The mean postpartum maternal anxiety level (mean ± SD) [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.

    2. The mean breastfeeding self-efficacy level [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 Outcome Measures

    1. Neonatal outcomes-Newborn weight (g) [at 2 weeks and 4 weeks after delivery]

      Newborn weight (g) was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery

    2. Neonatal outcomes-Hypoglycemia of the newborn [at 2 weeks and 4 weeks after delivery]

      Hypoglycemia of the newborn was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery.

    3. Neonatal outcomes-Need for phototherapy [at 2 weeks and 4 weeks after delivery]

      The need for phototherapy was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery

    4. Neonatal outcomes-Respiratory morbidity [at 2 weeks and 4 weeks after delivery]

      Respiratory morbidity was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery

    5. Neonatal outcomes-illness requiring hospitalization [at 2 weeks and 4 weeks after delivery]

      Illness requiring hospitalization was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery

    6. Neonatal outcomes-Food intake other than breast milk [at 2 weeks and 4 weeks after delivery]

      Food intake other than breast milk was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery

    7. Neonatal outcomes-Neonatal death [at 2 weeks and 4 weeks after delivery]

      Neonatal death was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kahramanmaras Sutcu Imam University Kahramanmaras Kahramanmaraş Turkey 4600

    Sponsors and Collaborators

    • Kahramanmaras Sutcu Imam University

    Investigators

    • Principal Investigator: Betül Bay, Kahramanmaras Sutcu Imam University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Deniz Akyıldız, Assistant Professor, Kahramanmaras Sutcu Imam University
    ClinicalTrials.gov Identifier:
    NCT04929561
    Other Study ID Numbers:
    • Breastfeeding Support
    First Posted:
    Jun 18, 2021
    Last Update Posted:
    Jun 18, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 18, 2021