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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05700162
Other study ID # EOU.SBE.OM.01
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 6, 2022
Est. completion date June 6, 2024

Study information

Verified date January 2023
Source Eskisehir Osmangazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Separation of the baby from the mother, being admitted to the neonatal intensive care unit can quickly increase the mother's fears about her baby's health and appearance, it can be interpreted as a crisis for the family. When the baby is in the intensive care unit, it also becomes difficult for parents to participate in the care of the baby. In this case, one of the negative emotions that parents often experience is anxiety. In general, mothers experience more intense stress than fathers.The mother, who is away from her baby's care, feels tense, irritable and confused. She makes an effort to reach her baby, and when she fails to do so, she finds herself helpless and powerless. The neonatal intensive care nurse and the Women's Health nurse play a major role in the initiation of breastfeeding and the continuation of breastfeeding in pre-term newborns. Early milking of mothers after premature birth increases breast milk production. Despite early and frequent milking, some mothers may experience lower milk volume and milk production in the first few weeks. Therefore, mothers with premature babies should practice frequent breastfeeding/milking, massage and compression, hot application, acupuncture, yoga and relaxation exercises, etc., in order to increase prolactin secretion and increase breast milk production. focused on non-pharmacological methods such as. Another method that is considered effective is to show the mother a photo or video of the baby during milking. However, in the literature review, the number of available studies on this subject is only 2. One of these studies was done in 2020. The other study was done in 2021. More work is needed on this subject. The aim of this study was to determine the effects of watching photos, videos and live images of babies during milking on the amount of breast milk, mother-infant attachment and breastfeeding self-efficacy.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date June 6, 2024
Est. primary completion date June 6, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 28 Days
Eligibility Inclusion Criteria: - Staying of the baby in the Neonatal Intensive Care Unit - 34 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.) Exclusion Criteria: - 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.)

Study Design


Intervention

Behavioral:
Photograph
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.
Video
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.
Live Broadcast
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.
Control Group
She will be asked to express both breasts for 15 minutes every 3 hours. No additional action will be taken.

Locations

Country Name City State
Turkey Eskisehir Osmangazi Üniversity Eskisehir Eskisehir

Sponsors (1)

Lead Sponsor Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Beck Anxiety Scale It was developed by Beck et al. in 1988. It was aimed to measure the frequency of anxiety symptoms experienced. 1 day
Other Sleeplessness Severity Index There are 7 questions in total. It is a tool for measuring the degree of insomnia. 1 day
Primary 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
Primary 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 Development of the breast milk expression experience measure It consists of 11 items. It is a five-point Likert scale. up to 2 days
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