BreastfeedingNCT04929561
The Effect of Breastfeeding Support Provided Via Video-conferencing
A study testing Video-conferencing group in people with Breastfeeding and Anxiety Disorders, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
A randomized control trial was made to examine the effects of breastfeeding support given by the video-conferencing method in the early postpartum period on anxiety, breastfeeding self-efficiency, and newborn outcomes. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Anxiety Disorders, Neonatal Outcomes
- What is being tested?
- Video-conferencing group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2020to 30 Sep 2021
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Infants;
- Born between 37 and 42 weeks
- Without severe congenital anomalies
- Mothers;
- A single live birth
- Were 18 years of age or over
Show all 10Show fewer
- At least primary school graduate
- Did not have a disease that prevents breastfeeding
- Had internet access at home or on the phone
- Could speak and understand the Turkish language.
Who cannot join
- Situations that cause separation of mother and baby
- Hospitalization of the baby in intensive care
- Inability to answer 3 calls in a video call
- They were determined as those who could not be reached during the home visit for the first and second follow
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaras Sutcu Imam University
Kahramanmaraş, Kahramanmaraş, 4600
Deniz Akyıldız, 05069851358, denizbtm@gmail.com
About this study
Official title: The Effect of Breastfeeding Support Provided Via Video-conferencing on Postpartum Anxiety, Breastfeeding Self-Efficacy and Neonatal Outcomes: A Randomized Controlled Trial
A randomized control trial was made to examine the effects of breastfeeding support given by the video-conferencing method in the early postpartum period on anxiety, breastfeeding self-efficiency, and newborn outcomes.
- Conditions
- Breastfeeding, Anxiety Disorders, Neonatal Outcomes
- Being tested
- Video-conferencing group
- Medical subject headings
- Breast Feeding, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-conferencing groupBehavioural
Also called Control group
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Video-conferencing group | Experimental | The mothers in the video-conferencing group were counseled via video-conferencing a total of six times (three times a week, at equal intervals) during the first 2 weeks after birth. Each interview was approximately 15-20 minutes. In video-conferencing sessions, the breastfeeding position, the mother's grasping the breast, the baby's latch-on, and sucking duration were observed. Mothers' questions were answered and solutions were offered for breastfeeding problems (sore nipple, engorgement, etc.). Receives: Behavioral: Video-conferencing group |
| Control group | No intervention | The mothers in the control group were given usual care before discharge and no intervention was made after discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean postpartum maternal anxiety level (mean ± SD)
The primary outcome of this study was the mean postpartum maternal anxiety level (mean ± SD) of the mothers at 2 weeks and 4 weeks after delivery. Maternal anxiety level was assessed using the Postpartum Specific Anxiety Scale. The scale comprises 51 items and 4 sub-dimensions. It means that those who score 73 and below on the scale have low postpartum anxiety levels, those who score between 74 and 100 have a medium level, and those who score 101 and above have a high level of anxiety.
Measured: at 2 weeks and 4 weeks after delivery
The mean breastfeeding self-efficacy level
The other main outcome of the study was the mean breastfeeding self-efficacy level (mean ± SD) measured with the Breastfeeding Self-Efficacy Scale Short Form. The scale is likert type and a total score between 14 and 70 is taken from the scale. The higher the score, the higher the breastfeeding self-efficacy.
Measured: at 2 weeks and 4 weeks after delivery
Secondary outcomes (7)
Neonatal outcomes-Newborn weight (g)
Newborn weight (g) was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
Measured: at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Hypoglycemia of the newborn
Hypoglycemia of the newborn was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery.
Measured: at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Need for phototherapy
The need for phototherapy was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
Measured: at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Respiratory morbidity
Respiratory morbidity was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
Measured: at 2 weeks and 4 weeks after delivery
Neonatal outcomes-illness requiring hospitalization
Illness requiring hospitalization was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
Measured: at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Food intake other than breast milk
Food intake other than breast milk was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
Measured: at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Neonatal death
Neonatal death was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
Measured: at 2 weeks and 4 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start25 Aug 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Akyıldız, Kahramanmaras Sutcu Imam University
- Investigators
- Betül Bay, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929561
- Sponsor's protocol ID
- Breastfeeding Support
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 18 Jun 2021
- 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding Support Provided Via Video-conferencing on Postpartum Anxiety, Breastfeeding Self-Efficacy and Neonatal Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04929561
- Acronym / sponsor ID
- Breastfeeding Support
- Conditions
- Breastfeeding, Anxiety Disorders, Neonatal Outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 18 Jun 2021 (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.
A randomized control trial was made to examine the effects of breastfeeding support given by the video-conferencing method in the early postpartum period on anxiety, breastfeeding self-efficiency, and newborn outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-conferencing group | Experimental | Behavioral: Video-conferencing groupThe mothers in the video-conferencing group were counseled via video-conferencing a total of six times (three times a week, at equal intervals) during the first 2 weeks after birth. Each interview was approximately 15-20 minutes. In video-conferencing sessions, the breastfeeding position, the mother's grasping the breast, the baby's latch-on, and sucking duration were observed. Mothers' questions were answered and solutions were offered for breastfeeding problems (sore nipple, engorgement, etc.). |
| Control group | No intervention | –The mothers in the control group were given usual care before discharge and no intervention was made after discharge. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Infants;
- Born between 37 and 42 weeks
- Without severe congenital anomalies
- Mothers;
- A single live birth
Key exclusion criteria (4 listed)
- Situations that cause separation of mother and baby
- Hospitalization of the baby in intensive care
- Inability to answer 3 calls in a video call
- They were determined as those who could not be reached during the home visit for the first and second follow
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 |
|---|---|---|
| Video-conferencing groupAlso: Control groupNo intervention | Behavioural | Video-conferencing group |
Primary outcome
The mean postpartum maternal anxiety level (mean ± SD)
Time frame: at 2 weeks and 4 weeks after delivery
The primary outcome of this study was the mean postpartum maternal anxiety level (mean ± SD) of the mothers at 2 weeks and 4 weeks after delivery. Maternal anxiety level was assessed using the Postpartum Specific Anxiety Scale. The scale comprises 51 items and 4 sub-dimensions. It means that those who score 73 and below on the scale have low postpartum anxiety levels, those who score between 74 and 100 have a medium level, and those who score 101 and above have a high level of anxiety.
The mean breastfeeding self-efficacy level
Time frame: at 2 weeks and 4 weeks after delivery
The other main outcome of the study was the mean breastfeeding self-efficacy level (mean ± SD) measured with the Breastfeeding Self-Efficacy Scale Short Form. The scale is likert type and a total score between 14 and 70 is taken from the scale. The higher the score, the higher the breastfeeding self-efficacy.
7 secondary outcomes
Neonatal outcomes-Newborn weight (g)
Time frame: at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Hypoglycemia of the newborn
Time frame: at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Need for phototherapy
Time frame: at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Respiratory morbidity
Time frame: at 2 weeks and 4 weeks after delivery
Neonatal outcomes-illness requiring hospitalization
Time frame: at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Food intake other than breast milk
Time frame: at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Neonatal death
Time frame: at 2 weeks and 4 weeks after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- 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.
Betül Bay principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-conferencing group in people with Breastfeeding and Anxiety Disorders, run by Kahramanmaras Sutcu Imam 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 10 inclusion and 4 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 18 Jun 2021. 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?
Contact Deniz Akyıldız, PhD (05069851358, denizbtm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean postpartum maternal anxiety level (mean ± SD) (time frame: at 2 weeks and 4 weeks after delivery). 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 18 Jun 2021.