Breast FeedingNCT05944471
The Effect of Telehealth on Feeding Exclusive Breastfeeding in the Perception of Insufficient Milk
A study testing Providing breastfeeding support with Telehealth in people with Breast Feeding and Exclusive Breastfeeding, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Exclusive Breastfeeding
- What is being tested?
- Providing breastfeeding support with Telehealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 10 Feb 2023
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.]
Read more
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.
- Conditions
- Breast Feeding, Exclusive Breastfeeding
- Being tested
- Providing breastfeeding support with Telehealth
- Keywords
- Telehealth, Exclusive Breastfeeding, Self-efficacy
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Providing breastfeeding support with TelehealthOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| Intervention Group | Experimental | 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. Receives: Other: Providing breastfeeding support with Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduce/eliminate the perception of insufficient milk
perceiving that mothers who experience inadequate milk perception are able to produce enough milk for their babies
Measured: 1-2 month
Secondary outcomes (1)
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
Measured: 1-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Sep 2021
- Primary completion1 Aug 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled experimental
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadire YILDIZ ÇİLTAŞ, Erzincan Binali Yildirim Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944471
- Sponsor's protocol ID
- NYILDIZCILTAS
- Status last verified
- Oct 2023
- First submitted
- 6 Jul 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05944471
- Acronym / sponsor ID
- NYILDIZCILTAS
- Conditions
- Breast Feeding, Exclusive Breastfeeding
- Keywords
- Telehealth, Exclusive Breastfeeding, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 13 Jul 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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled experimental
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| Intervention Group | Experimental | Other: Providing breastfeeding support with TelehealthInsufficient 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Providing breastfeeding support with TelehealthAfter 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. | Other | Intervention Group |
Primary outcome
reduce/eliminate the perception of insufficient milk
Time frame: 1-2 month
perceiving that mothers who experience inadequate milk perception are able to produce enough milk for their babies
1 secondary outcome
Mothers' Feeding Exclusive Breastfeeding to Their Babies in the First 6 Months
Time frame: 1-6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Providing breastfeeding support with Telehealth in people with Breast Feeding and Exclusive Breastfeeding, run by Karadeniz Technical 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?
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: finished, as of the sponsor's last update on 12 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
reduce/eliminate the perception of insufficient milk (time frame: 1-2 month). 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 Oct 2023.