The Effect of Telehealth on Feeding Exclusive Breastfeeding in the Perception of Insufficient Milk

The Effect of Breastfeeding Support Provided to Mothers With Insufficient Milk Perception by Telehealth Application on Mothers' Feeding Exclusive Breastfeeding to Their Babies in the First 6 Months

The goal of this [type of study: The study, which was carried out within the framework of mixed method, is a research using an explanatory sequential design, and its quantitative dimension is a randomized controlled experimental design] is to [The aim of this study is to determine the effect of breastfeeding support given to mothers with inadequate milk perception through telehealth application on mothers' giving only breast milk to their babies for the first six months] in [consisting of primiparous mothers, mothers who had normal vaginal deliveries and mothers with perceived inadequate milk, healthy term babies]. The main question[s] it aims to answer are:

• [What are the experiences of mothers with insufficient milk perception about the breastfeeding support given to their babies with telehealth application and their mothers' experiences about giving only breast milk to their babies for the first six months? ]
• [What is the satisfaction status of mothers with insufficient milk perception towards the breastfeeding support provided by telehealth application? ] Hypotheses of the Study
• [H0: Breastfeeding support provided to mothers with insufficient milk perception through telehealth application has no effect on the mother's exclusive breastfeeding in the first six months. ]
• [H1: Breastfeeding support provided to mothers with insufficient milk perception through telehealth application has an effect on the mother's exclusive breastfeeding for the first six months.]
• [H2: There is a difference between the mean breastfeeding self-efficacy and breastfeeding cessation tendency scale scores of the mothers in the control group and the intervention group with insufficient milk perception.]
• [H3: Mothers have a high level of satisfaction with the breastfeeding support provided by telehealth application.]

Intervention Group: The Inadequate Milk Perception Scale was applied to determine the mothers who thought that their milk was inadequate by face-to-face interview method before discharge from the hospital after delivery. Mothers with low scale scores were assigned to the control group in the first set and to the intervention group in the second set with the help of Research Randomiser (https://www.randomizer.org/). Then, Personal Information Form-1, Tendency to Discontinue Breastfeeding Scale, and Breastfeeding Self-Efficacy Scale were applied to the mothers. After discharge, training videos on the importance of breast milk and breastfeeding and written documents (e-brochure, prose version of breastfeeding trainings) prepared in line with the literature and explained by experts in accordance with the puerperium week between 10.00-14.00 hours were sent to the mothers individually with telehealth application once a week. At the same time intervals, visualised messages explaining breastfeeding and that breast milk is sufficient for the baby were sent via telehealth application five days a week. In addition, if the mothers requested at 10.00-17.00 on weekdays, they were given live support by the researcher for the issues they were curious about breastfeeding by calling the researcher via telehealth application. The mothers in the intervention group were called via telehealth application between the 2nd-5th postpartum days, 13th-17th days, 38th-40th days, 2nd-3rd months, 4th-5th months and at the end of the 6th month and the relevant forms were applied again (at the time period convenient for the mother).

Control Group: The Inadequate Milk Perception Scale was administered to the mothers to determine the mothers who thought that their milk was inadequate by face-to-face interview method before discharge from the hospital after delivery. Then, Personal Information Form-1, Tendency to Discontinue Breastfeeding Scale and Breastfeeding Self-Efficacy Scale were applied to the mothers. The mothers determined as the control group were called by the researcher via telehealth application between the 2nd-5th postpartum days, 13th-17th days, 38th-40th days, 2nd-3rd months, 4th-5th months and at the end of the 6th month by telehealth application and the relevant forms were applied again (at the time period convenient for the mother). No intervention was made to the mothers in the control group, and the woman benefited from routine outpatient clinic services if she requested.

Study Overview

• Status: Completed
• Conditions: Breast Feeding; Exclusive Breastfeeding
• Intervention / Treatment: Other: Providing breastfeeding support with Telehealth

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Trabzon, Turkey, 61080
    • University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

• To be able to read and write Turkish and not to have any disability in speaking,
• No desire to breastfeed your baby
• The mother should not have any health problem that would prevent breastfeeding and the baby should not have any health problem that would prevent breastfeeding,
• Having a smartphone and actively using one of the applications such as WhatsApp, Telegram, BIP etc,
• No internet connection problems,
• 37> weeks of gestation,
• Having a baby weighing at least 2500 g,
• Over 18 years of age,
• Primiparous
• Give birth to one healthy baby,
• Vaginal birth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The Inadequate Milk Perception Scale was administered to the mothers to determine the mothers who thought that their milk was inadequate by face-to-face interview method before discharge from the hospital after delivery. Mothers with low scale scores were randomly assigned to the control group as described in the intervention group. Then, Personal Information Form-1, Tendency to Discontinue Breastfeeding Scale and Breastfeeding Self-Efficacy Scale were applied to the mothers. The mothers determined as the control group were called by the investigators via telehealth application between the 2nd-5th days, 13th-17th days, 38th-40th days, 2nd-3rd months, 4th-5th months and at the end of the 6th month and the relevant forms were applied again. No intervention was made to the mothers in the control group.
Experimental: Intervention Group; Insufficient Milk Perception Scale, Personal Information Form, Tendency to Discontinue Breastfeeding Scale and Breastfeeding Self-Efficacy Scale were also administered to the mothers. After discharge, training videos and written documents were sent to the mothers individually via telehealth application once a week. Visualised messages explaining breastfeeding and that breastmilk is sufficient for the baby were also sent via telehealth application five days a week. Mothers were video-called between 10.00-17.00 on weekdays and live support was provided by the investigators. Mothers in the intervention group were called via telehealth application between the 2nd-5th days, 13th-17th days, 38th-40th days, 2nd-3rd months, 4th-5th months and at the end of the 6th month postpartum and the relevant forms were applied again. In addition, the qualitative questions in the "Semi-structured Interview Form" were asked at the end of the 6th month.	Other: Providing breastfeeding support with Telehealth; After discharge, training videos on the importance of breast milk and breastfeeding prepared in line with the literature and explained by experts, and written documents (e-brochure, plain text version of breastfeeding trainings) were sent to individual mothers once a week between 10.00-14.00 hours via telehealth application. At the same time intervals, visualised messages explaining breastfeeding and that breast milk is sufficient for the baby were sent via telehealth application five days a week. In addition, if the mothers requested at 10.00-17.00 on weekdays, they were given live support by the researcher for the issues they were curious about breastfeeding by calling the researcher via telehealth application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduce/eliminate the perception of insufficient milk	perceiving that mothers who experience inadequate milk perception are able to produce enough milk for their babies	1-2 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mothers' Feeding Exclusive Breastfeeding to Their Babies in the First 6 Months	to ensure that mothers feed their babies exclusively with breast milk for the first 6 months	1-6 month

Collaborators and Investigators

• Sponsor: Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Telehealth; Self-efficacy; Exclusive Breastfeeding
• Other Study ID Numbers: NYILDIZCILTAS

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