BreastfeedingNCT05199298
The Effect of Mandala Activity-Based Breastfeeding Program on Breastfeeding Self-Efficacy and Maternal-Infant Attachment of Primiparous Mothers
A study testing "Mandala Activity-Based Breastfeeding Program" in people with Breastfeeding and ART, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, ART, Self Efficacy
- What is being tested?
- "Mandala Activity-Based Breastfeeding Program"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 10 Oct 2022
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- pregnant women and infants with health problems
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
In this study, a mandala-based breastfeeding program will be applied to primiparous mothers at 32-36 weeks of gestation. The study will be conducted to determine the effect of mandala-based breastfeeding programs on postpartum breastfeeding self-efficacy, breastfeeding rates, and maternal-infant attachment of primiparous mothers. Training on breastfeeding and mother-baby bonding and mandala drawings supporting training will be sent online to primiparous pregnant women who are at 32-36 weeks of gestation and agree to participate in the study. The study is planned to be conducted with 72 pregnant women (intervention group=36, control group=36). 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.
- Conditions
- Breastfeeding, ART, Self Efficacy, Maternal-Fetal Relations
- Being tested
- "Mandala Activity-Based Breastfeeding Program"
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Mandala Activity-Based Breastfeeding Program"Other
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
| Study group | Role | What they receive |
|---|---|---|
| "Mandala Activity-Based Breastfeeding Program" | Experimental | The group receiving Mandala Activity-Based Breastfeeding Program Receives: Other: "Mandala Activity-Based Breastfeeding Program" |
| Control group | No intervention | the group that did not receive any training/initiative |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Spielberger State-Trait Anxiety Inventory (STAI)
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.
Measured: Change from Baseline level of Spielberger State-Trait Anxiety to 2 months (change is being assessed)]
Maternal Attachment Scale
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
Measured: Change from Baseline level of Maternal Attachment Scale at 2 months (change is being assessed)].
Postnatal Breastfeeding Self-Efficacy Scale
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.
Measured: Change from Baseline level of Postnatal Breastfeeding Self-Efficacy Scale at 2 months (change is being assessed)].
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Aug 2022
- Primary completion30 Sep 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Sarı Öztürk, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199298
- Sponsor's protocol ID
- CSOzturk
- Status last verified
- Dec 2022
- First submitted
- 1 Jan 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sari Ozturk C, Demir K. The Effect of Mandala Activity and Technology-Based Breastfeeding Program on Breastfeeding Self-Efficacy and Mother-Infant Attachment of Primiparous Women: A Randomized Controlled Study. J Med Syst. 2023 Apr 1;47(1):44. doi: 10.1007/s10916-023-01942-3.
PubMed 37004692
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Activity-Based Breastfeeding Program on Breastfeeding Self-Efficacy and Maternal-Infant Attachment of Primiparous Mothers
- ClinicalTrials.gov ID
- NCT05199298
- Acronym / sponsor ID
- CSOzturk
- Conditions
- Breastfeeding, ART, Self Efficacy, Maternal-Fetal Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 20 Jan 2022 (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.
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.
Detailed description
In this study, a mandala-based breastfeeding program will be applied to primiparous mothers at 32-36 weeks of gestation. The study will be conducted to determine the effect of mandala-based breastfeeding programs on postpartum breastfeeding self-efficacy, breastfeeding rates, and maternal-infant attachment of primiparous mothers. Training on breastfeeding and mother-baby bonding and mandala drawings supporting training will be sent online to primiparous pregnant women who are at 32-36 weeks of gestation and agree to participate in the study. The study is planned to be conducted with 72 pregnant women (intervention group=36, control group=36). 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Mandala Activity-Based Breastfeeding Program" | Experimental | Other: "Mandala Activity-Based Breastfeeding Program"The group receiving Mandala Activity-Based Breastfeeding Program |
| Control group | No intervention | –the group that did not receive any training/initiative |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (1 listed)
- pregnant women and infants with health problems
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 |
|---|---|---|
| "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 | Other | "Mandala Activity-Based Breastfeeding Program" |
Primary outcome
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.
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
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.
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 13 Dec 2022.
- Derived from this study: PubMed 37004692Sari Ozturk C, Demir K. The Effect of Mandala Activity and Technology-Based Breastfeeding Program on Breastfeeding Self-Efficacy and Mother-Infant Attachment of Primiparous Women: A Randomized Controlled Study. J Med Syst. 2023 Apr 1;47(1):44. doi: 10.1007/s10916-023-01942-3.
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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 "Mandala Activity-Based Breastfeeding Program" in people with Breastfeeding and ART, run by Gazi 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 13 inclusion and 1 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: finished, as of the sponsor's last update on 13 Dec 2022. 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?
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 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?
On the ClinicalTrials.gov record for NCT05199298, which also lists 1 linked publication.
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 13 Dec 2022.