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The Effect of Breastfeeding Support Provided Via Video-conferencing

Primary Purpose

Breastfeeding, Anxiety Disorders, Neonatal Outcomes

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Video-conferencing group
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breastfeeding

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kahramanmaras Sutcu Imam UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Video-conferencing group

Control group

Arm Description

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.).

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Neonatal outcomes-Newborn weight (g)
Newborn weight (g) was evaluated using the Follow-up Form 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.
Neonatal outcomes-Need for phototherapy
The need for phototherapy was evaluated using the Follow-up Form 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
Neonatal outcomes-illness requiring hospitalization
Illness requiring hospitalization was evaluated using the Follow-up Form 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
Neonatal outcomes-Neonatal death
Neonatal death was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery

Full Information

First Posted
June 7, 2021
Last Updated
June 15, 2021
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT04929561
Brief Title
The Effect of Breastfeeding Support Provided Via Video-conferencing
Official Title
The Effect of Breastfeeding Support Provided Via Video-conferencing on Postpartum Anxiety, Breastfeeding Self-Efficacy and Neonatal Outcomes: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Anxiety Disorders, Neonatal Outcomes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Video-conferencing group
Arm Type
Experimental
Arm Description
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.).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The mothers in the control group were given usual care before discharge and no intervention was made after discharge.
Intervention Type
Behavioral
Intervention Name(s)
Video-conferencing group
Other Intervention Name(s)
Control group
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
The mean postpartum maternal anxiety level (mean ± SD)
Description
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.
Time Frame
at 2 weeks and 4 weeks after delivery
Title
The mean breastfeeding self-efficacy level
Description
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.
Time Frame
at 2 weeks and 4 weeks after delivery
Secondary Outcome Measure Information:
Title
Neonatal outcomes-Newborn weight (g)
Description
Newborn weight (g) was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
Time Frame
at 2 weeks and 4 weeks after delivery
Title
Neonatal outcomes-Hypoglycemia of the newborn
Description
Hypoglycemia of the newborn was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery.
Time Frame
at 2 weeks and 4 weeks after delivery
Title
Neonatal outcomes-Need for phototherapy
Description
The need for phototherapy was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
Time Frame
at 2 weeks and 4 weeks after delivery
Title
Neonatal outcomes-Respiratory morbidity
Description
Respiratory morbidity was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
Time Frame
at 2 weeks and 4 weeks after delivery
Title
Neonatal outcomes-illness requiring hospitalization
Description
Illness requiring hospitalization was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
Time Frame
at 2 weeks and 4 weeks after delivery
Title
Neonatal outcomes-Food intake other than breast milk
Description
Food intake other than breast milk was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
Time Frame
at 2 weeks and 4 weeks after delivery
Title
Neonatal outcomes-Neonatal death
Description
Neonatal death was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
Time Frame
at 2 weeks and 4 weeks after delivery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deniz Akyıldız, PhD
Phone
05069851358
Email
denizbtm@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Deniz Akyıldız
Phone
05069851358
Email
denizbtm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betül Bay
Organizational Affiliation
Kahramanmaras Sutcu Imam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University
City
Kahramanmaras
State/Province
Kahramanmaraş
ZIP/Postal Code
4600
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deniz Akyıldız
Phone
05069851358
Email
denizbtm@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Breastfeeding Support Provided Via Video-conferencing

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