- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05199298
The Effect of Mandala Activity-Based Breastfeeding Program on Breastfeeding Self-Efficacy and Maternal-Infant Attachment of Primiparous Mothers
This study will be conducted to determine the effect of breastfeeding program integrated with art therapy such as mandala painting on postpartum breastfeeding self-efficacy, breastfeeding rates, and mother-infant attachment of primiparous mothers.
Training on breastfeeding and mother-baby bonding and mandala drawings supporting the training will be sent online to primiparous pregnant women who are at 32-36 weeks of gestation and agree to participate in the study. Telephone follow-up and counseling will continue in the postpartum period. In the postpartum period, follow-up and counseling will continue until the second month.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey
- Gazi University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primiparous pregnancy,
- Being at 32-33 weeks of gestation,
- Being over 18 years old,
- To be at least a primary school graduate,
- Owning a phone,
- Having internet access at home or at work,
- Using the internet,
- Being able to speak Turkish,
- Mothers who agreed to participate in the study
For infants;
- Born at 37-42 weeks of gestation,
- Birth weight between 2500-4000 g,
- Infants without any health problems or congenital anomalies were included in the study.
Exclusion Criteria:
- pregnant women and infants with health problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: "Mandala Activity-Based Breastfeeding Program"
The group receiving Mandala Activity-Based Breastfeeding Program
|
Training modules for breastfeeding and Maternal -infant attachment will be implemented with pregnant women in the study group at 32-36 weeks of gestation.
The training will be explained by the researchers by shooting a video.
In addition, for each week, mandala drawings will be videotaped by the researcher who received mindfulness-based art therapy training and will be sent to the Whatsapp accounts of the pregnant women.
t 36 weeks of gestation, the Prenatal Attachment Scale and Spielberger State Anxiety Inventories will be sent to mothers as Google forms.
The mother will be called 24 hours after the birth and the situation of having a problem with breastfeeding will be determined.
In the first week, in the first and second months after the birth, questionnaire forms and online questionnaires will be applied to the mothers, apart from the follow-up and counseling in the postpartum 2nd month, the posttests of the scales
|
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No Intervention: Control group
the group that did not receive any training/initiative
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Spielberger State-Trait Anxiety Inventory (STAI)
Time Frame: Change from Baseline level of Spielberger State-Trait Anxiety to 2 months (change is being assessed)]
|
The scale is a 20-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item.
The total score obtained from the scale varies between 20 and 80.
A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
|
Change from Baseline level of Spielberger State-Trait Anxiety to 2 months (change is being assessed)]
|
|
Maternal Attachment Scale
Time Frame: Change from Baseline level of Maternal Attachment Scale at 2 months (change is being assessed)].
|
The scale consists of 26 statements and is a four-point Likert type.
High score indicates that maternal attachment is high.
The scores obtained from the scale range from a minimum of 26 to a maximum of 104 points
|
Change from Baseline level of Maternal Attachment Scale at 2 months (change is being assessed)].
|
|
Postnatal Breastfeeding Self-Efficacy Scale
Time Frame: Change from Baseline level of Postnatal Breastfeeding Self-Efficacy Scale at 2 months (change is being assessed)].
|
The scale is 5-point Likert type and consists of 14 items.
The lowest score that can be obtained from the scale is 14, and the highest score is 70.
A higher score means higher breastfeeding self-efficacy.
|
Change from Baseline level of Postnatal Breastfeeding Self-Efficacy Scale at 2 months (change is being assessed)].
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CSOzturk
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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