MindfulnessNCT05682014
The Effect of Web-Based Mindful Breastfeeding Program During Pregnancy on Postpartum Breastfeeding
A study testing Mindful Breastfeeding Program in people with Mindfulness and Breast Feeding, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effectiveness of a web-based mindful breastfeeding program in pregnancy to increase awareness, breastfeeding adaptation and breastfeeding self-efficacy in postpartum breastfeeding. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Breast Feeding, Psychological Well-Being
- What is being tested?
- Mindful Breastfeeding Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Apr 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Able to communicate in Turkish,
- Being literate,
- Over 18 years old,
- Having primigravida,
- Conceiving naturally,
- Gestational week between 28-32 weeks,
Show all 11Show fewer
- Having a single baby (no multiple pregnancy),
- Intention to breastfeed their baby after birth,
- The mother and her baby do not have any health problems,
- Having a smart phone and wireless internet,
- All pregnant women who score below 5 points in the depression sub-dimension, below 4 points in the anxiety sub-dimension, and below 8 points in the stress sub-dimension according to DASS-21 will be included in the sample.
Who cannot join
- If the participant states that he/she wants to withdraw from the research,
- Not attending at least two training sessions,
- Premature birth (before 37 weeks of pregnancy),
- Not breastfeeding the baby after birth,
- Not participating in the post-test,
- Failure to complete the follow-up period for any reason.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul
Özge Şiir Dağlar, PhD student, +90 544 226 45 85, ozgesiirdaglar@gmail.com
İlkay Güngör Satılmış, Associate professor, +90 535 646 47 68, ilkay1979@yahoo.com
About this study
The aim of this study is to evaluate the effectiveness of a web-based mindful breastfeeding program in pregnancy to increase awareness, breastfeeding adaptation and breastfeeding self-efficacy in postpartum breastfeeding. The Mindful breastfeeding program intervention will be compared to the group receiving basic breastfeeding education. The main hypothesis is that pregnant women included in the mindful breastfeeding program have higher postpartum breastfeeding awareness, breastfeeding adaptation and breastfeeding self-efficacy.
Read the detailed description
The aim of this study is to evaluate the effectiveness of a web-based mindful breastfeeding program in pregnancy to increase awareness, breastfeeding adaptation and breastfeeding self-efficacy in postpartum breastfeeding.
There will be two groups in the study:
The web-based "Mindful Breastfeeding Program" (mindfulness-based breastfeeding program) consisting of 8 sessions in total, 2 sessions per week for 4 weeks, will be applied to the pregnant women who make up the intervention group. During the research, a QR code supported website will be established in order to support the awareness practices of the participants at home. While doing mindfulness practices at home, participants will be able to benefit from the short training videos on the website or the audio recordings prepared by the researcher with his own voice.
Only one session online breastfeeding training will be given to the control group and the training brochure for this training will be delivered to the participants via whatsapp.
A total of 40 pregnant women, 20 in the intervention group and 20 in the control group, will form the sample of the study. The main hypothesis is that the postpartum breastfeeding awareness, breastfeeding adaptation and breastfeeding self-efficacy of pregnant women included in the mindful breastfeeding program is higher than the pregnant women who participated in the single-session basic breastfeeding training.
Statistical analysis of the data obtained from the research will be made using SPSS (Statistical Packet for Social Science) for Windows 25.0 program.
- Conditions
- Mindfulness, Breast Feeding, Psychological Well-Being
- Being tested
- Mindful Breastfeeding Program
- Keywords
- Mindfulness, Breast Feeding, Psychological Well-Being
- Medical subject headings
- Breast Feeding, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Breastfeeding ProgramBehavioural
A web-based "Mindful Breastfeeding Program", which is applied to pregnant women in groups of 5, consisting of 8 sessions, 2 sessions per week for 4 weeks.
Mindful breastfeeding program will consist of breastfeeding education, introduction to the concept of mindfulness, mindful breastfeeding, practical suggestions to pregnant women by the researcher, providing a discussion environment for them to share their experiences, and homework on the content of the program.
A web site with written material, video and audio recordings will be created and presented to the participants as a support element.
In order for them to use mindfulness practices in their daily lives, motivational WhatsApp short messages will be sent by the researcher daily during the training, weekly during the post-training period, and daily in the postpartum period.
| Study group | Role | What they receive |
|---|---|---|
| İntervention Group | Experimental | A web-based "Mindful Breastfeeding Program", which is applied to pregnant women in groups of 5, consisting of 8 sessions, 2 sessions per week for 4 weeks.
Mindful breastfeeding program will consist of breastfeeding education, introduction to the concept of mindfulness, mindful breastfeeding, practical suggestions to pregnant women by the researcher, providing a discussion environment for them to share their experiences, and homework on the content of the program.
A web site with written material, video and audio recordings will be created and presented to the participants as a support element.
In order for them to use mindfulness practices in their daily lives, motivational WhatsApp short messages will be sent by the researcher daily during the training, weekly during the post-training period, and daily in the postpartum period. Receives: Behavioral: Mindful Breastfeeding Program |
| Control Group | No intervention | Only one session online breastfeeding training will be given and the training brochure for this training will be delivered to the participants via whatsapp. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindful Breastfeeding Scale
Measured: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Breast Feeding Adaptation Scale
Measured: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Postpartum Breastfeeding Self-Efficacy Scale
Measured: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Secondary outcomes (8)
Sociodemographic Information Form
Measured: Mindful breastfeeding program pre-intervention in intervention group and control group.
Antenatal Breastfeeding Self-Efficacy Scale
Measured: Mindful breastfeeding program pre-intervention in intervention group and control group.
Depression, Anxiety, Stress Scale
Measured: Mindful breastfeeding program pre-intervention in intervention group and control group.
Depression, Anxiety, Stress Scale
Measured: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Mindfulness Scale
Measured: Mindful breastfeeding program pre-intervention in intervention group and control group.
Mindfulness Scale
Measured: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Postpartum Breastfeeding Evaluation Form
A form developed by the researcher to evaluate the breastfeeding status of mothers in the first 7 days after birth (average between 3-5 days).
Measured: Mindful breastfeeding program within the first 7 days postpartum in the intervention group and control group.
System Usability Scale
The usability of the website will be evaluated by the participants in the intervention group at the last session of the training program using the System Usability Scale (SUS).
Measured: Immediately after intervention in the Mindful breastfeeding program intervention group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies 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
- Random sampling method will be used in the research. Randomization Pregnant women will be evaluated in terms of their eligibility for the study, a list of pregnant women included in the study will be created and divided into two groups. The assignment of pregnant women to the intervention and control groups in the study will be realized by assigning a number to each of the participants, forming a number group for the intervention group, and planning the numbers outside of this group as the control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Principal investigator, Özge Şiir Dağlar, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682014
- Sponsor's protocol ID
- IUC-OSDaglar-001
- Status last verified
- Aug 2023
- First submitted
- 27 Dec 2022
- Last updated
- 1 Sep 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 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-Based Mindful Breastfeeding Program During Pregnancy on Postpartum Breastfeeding
- ClinicalTrials.gov ID
- NCT05682014
- Acronym / sponsor ID
- IUC-OSDaglar-001
- Conditions
- Mindfulness, Breast Feeding, Psychological Well-Being
- Keywords
- Mindfulness, Breast Feeding, Psychological Well-Being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 12 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 aim of this study is to evaluate the effectiveness of a web-based mindful breastfeeding program in pregnancy to increase awareness, breastfeeding adaptation and breastfeeding self-efficacy in postpartum breastfeeding. The Mindful breastfeeding program intervention will be compared to the group receiving basic breastfeeding education. The main hypothesis is that pregnant women included in the mindful breastfeeding program have higher postpartum breastfeeding awareness, breastfeeding adaptation and breastfeeding self-efficacy.
Detailed description
The aim of this study is to evaluate the effectiveness of a web-based mindful breastfeeding program in pregnancy to increase awareness, breastfeeding adaptation and breastfeeding self-efficacy in postpartum breastfeeding.
There will be two groups in the study:
The web-based "Mindful Breastfeeding Program" (mindfulness-based breastfeeding program) consisting of 8 sessions in total, 2 sessions per week for 4 weeks, will be applied to the pregnant women who make up the intervention group. During the research, a QR code supported website will be established in order to support the awareness practices of the participants at home. While doing mindfulness practices at home, participants will be able to benefit from the short training videos on the website or the audio recordings prepared by the researcher with his own voice.
Only one session online breastfeeding training will be given to the control group and the training brochure for this training will be delivered to the participants via whatsapp.
A total of 40 pregnant women, 20 in the intervention group and 20 in the control group, will form the sample of the study. The main hypothesis is that the postpartum breastfeeding awareness, breastfeeding adaptation and breastfeeding self-efficacy of pregnant women included in the mindful breastfeeding program is higher than the pregnant women who participated in the single-session basic breastfeeding training.
Statistical analysis of the data obtained from the research will be made using SPSS (Statistical Packet for Social Science) for Windows 25.0 program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Random sampling method will be used in the research. Randomization Pregnant women will be evaluated in terms of their eligibility for the study, a list of pregnant women included in the study will be created and divided into two groups. The assignment of pregnant women to the intervention and control groups in the study will be realized by assigning a number to each of the participants, forming a number group for the intervention group, and planning the numbers outside of this group as the control group.
| Arm | Type | Receives |
|---|---|---|
| İntervention Group | Experimental | Behavioral: Mindful Breastfeeding ProgramA web-based "Mindful Breastfeeding Program", which is applied to pregnant women in groups of 5, consisting of 8 sessions, 2 sessions per week for 4 weeks. Mindful breastfeeding program will consist of breastfeeding education, introduction to the concept of mindfulness, mindful breastfeeding, practical suggestions to pregnant women by the researcher, providing a discussion environment for them to share their experiences, and homework on the content of the program. A web site with written material, video and audio recordings will be created and presented to the participants as a support element. In order for them to use mindfulness practices in their daily lives, motivational WhatsApp short messages will be sent by the researcher daily during the training, weekly during the post-training period, and daily in the postpartum period. |
| Control Group | No intervention | –Only one session online breastfeeding training will be given and the training brochure for this training will be delivered to the participants via whatsapp. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Able to communicate in Turkish,
- Being literate,
- Over 18 years old,
- Having primigravida,
- Conceiving naturally,
Key exclusion criteria (6 listed)
- If the participant states that he/she wants to withdraw from the research,
- Not attending at least two training sessions,
- Premature birth (before 37 weeks of pregnancy),
- Not breastfeeding the baby after birth,
- Not participating in the post-test,
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 |
|---|---|---|
| Mindful Breastfeeding ProgramA web-based "Mindful Breastfeeding Program", which is applied to pregnant women in groups of 5, consisting of 8 sessions, 2 sessions per week for 4 weeks. Mindful breastfeeding program will consist of breastfeeding education, introduction to the concept of mindfulness, mindful breastfeeding, practical suggestions to pregnant women by the researcher, providing a discussion environment for them to share their experiences, and homework on the content of the program. A web site with written material, video and audio recordings will be created and presented to the participants as a support element. In order for them to use mindfulness practices in their daily lives, motivational WhatsApp short messages will be sent by the researcher daily during the training, weekly during the post-training period, and daily in the postpartum period. | Behavioural | İntervention Group |
Primary outcome
Mindful Breastfeeding Scale
Time frame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Breast Feeding Adaptation Scale
Time frame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Postpartum Breastfeeding Self-Efficacy Scale
Time frame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
8 secondary outcomes
Sociodemographic Information Form
Time frame: Mindful breastfeeding program pre-intervention in intervention group and control group.
Antenatal Breastfeeding Self-Efficacy Scale
Time frame: Mindful breastfeeding program pre-intervention in intervention group and control group.
Depression, Anxiety, Stress Scale
Time frame: Mindful breastfeeding program pre-intervention in intervention group and control group.
Depression, Anxiety, Stress Scale
Time frame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Mindfulness Scale
Time frame: Mindful breastfeeding program pre-intervention in intervention group and control group.
Mindfulness Scale
Time frame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Postpartum Breastfeeding Evaluation Form
Time frame: Mindful breastfeeding program within the first 7 days postpartum in the intervention group and control group.
System Usability Scale
Time frame: Immediately after intervention in the Mindful breastfeeding program intervention group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Breastfeeding Program in people with Mindfulness and Breast Feeding, run by Istanbul University - Cerrahpasa 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 11 inclusion and 6 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 1 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özge Şiir Dağlar, PhD student (+90 544 226 45 85, ozgesiirdaglar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindful Breastfeeding Scale (time frame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.). The study lists 3 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 1 Sep 2023.