Breast Milk ExpressionNCT05700162
The Effect of Showing Photographs, Videos and Live Images of Their Babies to Mothers During Milking
A study testing Photograph, Video and Live Broadcast in people with Breast Milk Expression and Breast Milk Collection, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Expression, Breast Milk Collection, Mother-Infant Interaction
- What is being tested?
- Photograph, Video and Live Broadcast
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2022to 8 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.)
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi Üniversity
Eskişehir, Eskişehir
About this study
Official title: The Effect of Showing Photographs, Videos and Live Images of Their Babies to Mothers During Milking on Breastmilk Amount, Mother-Infant Attachment and Breastfeeding Self-Efficacy Level: Randomized Controlled Experimental Study
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.
Read the detailed 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.
- Being tested
- Photograph, Video, Live Broadcast, Control Group
- Keywords
- prematüre, neonatal intensive care, breast milk
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotographBehavioural
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.
VideoBehavioural
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 BroadcastBehavioural
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 GroupBehavioural
She will be asked to express both breasts for 15 minutes every 3 hours. No additional action will be taken.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 2 days
Secondary outcomes (1)
Development of the breast milk expression experience measure
It consists of 11 items. It is a five-point Likert scale.
Measured: up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start6 Jun 2022
- Primary completion8 Aug 2024 (estimated)
- Study completion8 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Milk ExpressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem MUMCU, Eskisehir Osmangazi University
- Investigators
- Ayfer Açıkgöz, Study director, ayferacikgoz u.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700162
- Sponsor's protocol ID
- EOU.SBE.OM.01
- Status last verified
- Jun 2024
- First submitted
- 4 Jan 2023
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Showing Photographs, Videos and Live Images of Their Babies to Mothers During Milking on Breastmilk Amount, Mother-Infant Attachment and Breastfeeding Self-Efficacy Level: Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT05700162
- Acronym / sponsor ID
- EOU.SBE.OM.01
- Keywords
- prematüre, neonatal intensive care, breast milk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 8 Aug 2024 (estimated)
- Study completion
- 8 Aug 2024 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Photograph | Experimental | Behavioral: PhotographAs 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. |
| Video | Experimental | Behavioral: VideoAs 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. |
| Live Broadcast | Experimental | Behavioral: Live BroadcastAs 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. |
| Control Group | Experimental | Behavioral: Control GroupThe mother will be asked to express both breasts for 15 minutes every 3 hours. No additional application will be made. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotographAs 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. | Behavioural | Photograph |
| VideoAs 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. | Behavioural | Video |
| Live BroadcastAs 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. | Behavioural | Live Broadcast |
| Control GroupShe will be asked to express both breasts for 15 minutes every 3 hours. No additional action will be taken. | Behavioural | Control Group |
Primary outcome
Mother-to-Infant Bonding Scale
Time frame: up to 2 days
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.
The Breastfeeding Self-Efficacy Scale: Psychometric Assessment of the Short Form
Time frame: up to 2 days
It consists of 33 items. It is a five-point Likert scale.
1 secondary outcome
Development of the breast milk expression experience measure
Time frame: up to 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayfer Açıkgöz study director
ayferacikgoz u.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photograph, Video and Live Broadcast in people with Breast Milk Expression and Breast Milk Collection, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother-to-Infant Bonding Scale (time frame: up to 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.