Protocol summary
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Study aim
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Evaluating the Impact of Tele-Nursing on Self-Efficacy, Social Support, and Exclusive Breastfeeding Experience in First-Time Mothers
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Design
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A controlled, parallel-group, randomized phase 2 clinical trial conducted on 280 patients. Eligible participants were individually allocated to the intervention or control group using block randomization with a block size of four and a 1:1 allocation ratio.
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Settings and conduct
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Study location: The labor and delivery unit of Shahid Doctor Beheshti Hospital in Maragheh.
Study population: Postpartum mothers following hospital discharge.
Methodological note: No blinding will be performed in this study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Primiparous mothers; Informed parental consent to participate in the study; Breastfeeding the infant at the time of discharge; Having family support for the mother (mother, spouse, etc.); Gestational age of 37-42 weeks at delivery.
Exclusion criteria: Medical contraindication for breastfeeding in mother or infant; Parents employed in hospital-related professions; Any congenital anomalies or abnormalities in the infant
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Intervention groups
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Control Group:The control group will receive only standard care.
Intervention Group:An educational channel and training group will be established on approved national platforms. The intervention will consist of four stages of breastfeeding counseling, conducted according to the GATHER counseling principles.
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Main outcome variables
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Breastfeeding self-efficacy, maternal breastfeeding social support, mothers' exclusive breastfeeding experience
General information
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Reason for update
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The trial record is being updated to correct, complete, and clarify the information regarding the allocation of participants. In the previous version of the record, the participant allocation method was described as pseudorandom allocation based on the parity (even or odd) of the hospital record number. This description did not accurately and completely reflect the allocation method used in the conduct of the study. Therefore, the randomization-related information is being revised to accurately and transparently document the participant allocation procedure used in the trial.
Specifically, the “Randomization (investigator's opinion)” field is being changed from “Not randomized” to “Randomized,” and the “Randomization description” field is being revised to describe individual-level block randomization with a block size of four and a 1:1 allocation ratio. The formation of six possible allocation sequences and the random selection with replacement of 70 blocks to generate the allocation sequence for 280 participants are also documented. This update is intended to improve the accuracy and transparency of the trial record and to accurately reflect the allocation method used in the study.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20241225064172N1
Registration date:
2025-05-28, 1404/03/07
Registration timing:
prospective
Last update:
2026-09-30, 1405/07/08
Update count:
1
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Registration date
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2025-05-28, 1404/03/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-06-05, 1404/03/15
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Expected recruitment end date
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2025-12-06, 1404/09/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of telenursing on self-efficacy, social support, and exclusive breastfeeding experience of primiparous mothers: A clinical trial study
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Public title
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The effect of telenursing on self-efficacy, social support, and exclusive breastfeeding experience of primiparous mothers
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Primiparous mothers
Informed parental consent to participate in the study
Exclusive breastfeeding at the time of discharge
Ability to read and write in Persian (Parents)
Family support for the mother from her mother, spouse, etc
Owning a mobile phone compatible with the Ita app
Gestational age of 37–42 weeks at the birth of term infants
Exclusion criteria:
Medical contraindication for breastfeeding for either mother or infant
Employed in a hospital-related profession
Congenital anomalies or abnormalities in the infant
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
280
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants were individually allocated to the intervention or control group using block randomization with a block size of four and a 1:1 allocation ratio. Six possible allocation sequences were formed, with each block containing two intervention and two control allocations in different sequences. Seventy blocks were randomly selected with replacement to generate the allocation sequence for the 280 participants. Participants were subsequently allocated sequentially to the intervention or control group according to the resulting randomization sequence. No stratified randomization was used. The randomization sequence was generated before participant allocation.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-04-16, 1404/01/27
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Ethics committee reference number
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IR.MARAGHEHPHC.REC.1404.001
Health conditions studied
1
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Description of health condition studied
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Breastfeeding Education for Mothers via Tele-Nursing
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Self-efficacy score of primiparous mothers
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Timepoint
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Before the intervention, and at one week, one month, and six months after the intervention
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Method of measurement
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Dennis Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
2
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Description
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Maternal Breastfeeding Social Support
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Timepoint
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Before the intervention, and at one week, one month, and six months after the intervention
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Method of measurement
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Exclusive Breastfeeding Social Support Scale
3
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Description
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Mothers' Experience of Exclusive Breastfeeding
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Timepoint
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Before the intervention, and at one week, one month, and six months after the intervention
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Method of measurement
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Breastfeeding Experience Scale (BES)
Intervention groups
1
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Description
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Intervention group: An educational channel and educational group will be established in nationally authorized settings, and the intervention will be carried out in four stages, according to the GATHER counseling principles and the Ministry of Health breastfeeding protocol. (Each of the stages will be carried out for one week, two days a week, on Saturdays and Mondays at 7 p.m.) We will explain to the mothers that they should view the educational content with a sponsor (mother or spouse or...). The questionnaires of the present study will be completed by the participants before the start of the intervention, one week, one month, and six months after the end of the intervention.
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Category
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Other
2
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Description
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Control group: Mothers in the control group will receive only standard care, including routine breastfeeding education and pamphlets about breastfeeding.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Maragheh University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The study results will be published in the groups and channels created for participants, without mentioning any personal names
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When the data will become available and for how long
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Access period begins 6 months after results publication
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To whom data/document is available
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Mothers of infants
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Under which criteria data/document could be used
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For training purposes at the hospital
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From where data/document is obtainable
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laila30968@gmail.com
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What processes are involved for a request to access data/document
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Sending an email
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Comments
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Please ensure the registered data becomes visible after article publication.