NCT05700162

Brief Summary

The study was planned to determine the effect of showing photographs, videos and live images of premature babies who could not be breastfed in the neonatal intensive care unit to their mothers on the amount of breast milk, mother-infant attachment and breastfeeding self-efficacy. It is a randomized controlled experimental study.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

June 6, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2024

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

January 4, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

prematüreneonatal intensive carebreast milk

Outcome Measures

Primary Outcomes (2)

  • Mother-to-Infant Bonding Scale

    It is a measurement tool that can be applied from the first day after birth and allows the mother to express her feelings towards her baby with a single word.

    up to 2 days

  • The Breastfeeding Self-Efficacy Scale: Psychometric Assessment of the Short Form

    It consists of 33 items. It is a five-point Likert scale.

    up to 2 days

Secondary Outcomes (1)

  • Development of the breast milk expression experience measure

    up to 2 days

Other Outcomes (2)

  • Beck Anxiety Scale

    1 day

  • Sleeplessness Severity Index

    1 day

Study Arms (4)

Photograph

EXPERIMENTAL

As soon as the mother starts to express her milk, she will be asked to look at the photo of her baby sent to her on whatsapp for 5 minutes.

Behavioral: Photograph

Video

EXPERIMENTAL

As soon as the mother starts to express her milk, she will be asked to watch the 5-minute video of her baby sent to her on whatsapp.

Behavioral: Video

Live Broadcast

EXPERIMENTAL

As soon as the mother starts to express her milk, she will be asked to watch the 5-minute live video of her baby with the call sent to her from WhatsApp.

Behavioral: Live Broadcast

Control Group

EXPERIMENTAL

The mother will be asked to express both breasts for 15 minutes every 3 hours. No additional application will be made.

Behavioral: Control Group

Interventions

PhotographBEHAVIORAL

As soon as she starts to express her milk from the mother, on whatsapp will be asked to look at the photo of the baby sent to her for 5 minutes. She will be asked to express both breasts for 15 minutes every 3 hours.

Photograph
VideoBEHAVIORAL

As soon as the mother starts to express her milk, she will be asked to watch the 5-minute video of her baby sent to her on WhatsApp. She will be asked to express both breasts for 15 minutes every 3 hours.

Video
Live BroadcastBEHAVIORAL

As soon as the mother starts to express her milk, she will be asked to watch the 5-minute live video of her baby with the call sent to her from WhatsApp. She will be asked to express both breasts for 15 minutes every 3 hours.

Live Broadcast
Control GroupBEHAVIORAL

She will be asked to express both breasts for 15 minutes every 3 hours. No additional action will be taken.

Control Group

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Staying of the baby in the Neonatal Intensive Care Unit
  • weeks of gestation and below
  • Mother's acceptance of the application
  • The mother's inability to breastfeed her baby
  • The mother has a smart mobile phone
  • Mother's ability to read and write
  • Being able to communicate with the mother (being able to read and write, speak Turkish, etc.)

You may not qualify if:

  • Gestation week over 34
  • The mother is breastfeeding her baby
  • Being a smoker
  • Having a systemic disease and constantly taking medication(s)
  • Having a health problem that may affect the mother's milking (crack, mastitis, collapse etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi Üniversity

Eskişehir, Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Milk Expression

Interventions

Moire TopographyVideotape RecordingControl Groups

Condition Hierarchy (Ancestors)

Breast FeedingFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

PhotogrammetryPhotographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInterferometryInvestigative TechniquesTape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevisionEpidemiologic Research DesignEpidemiologic MethodsResearch DesignMethods

Study Officials

  • Ayfer Açıkgöz

    ayferacikgoz u.edu.tr

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse Specialist

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 26, 2023

Study Start

June 6, 2022

Primary Completion

August 8, 2024

Study Completion

August 8, 2024

Last Updated

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations