NCT04929561

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

June 7, 2021

Last Update Submit

June 15, 2021

Conditions

BreastfeedingAnxiety DisordersNeonatal Outcomes

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Video-conferencing group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The mothers in the control group were given usual care before discharge and no intervention was made after discharge.

Interventions

Video-conferencing groupBEHAVIORAL

No intervention

Also known as: Control group
Video-conferencing group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Kahramanmaraş, 4600, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast FeedingAnxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Betül Bay

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deniz Akyıldız, PhD

CONTACT

05069851358denizbtm@gmail.com

Deniz Akyıldız

CONTACT

05069851358denizbtm@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 18, 2021

Study Start

August 25, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)