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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05199298
Other study ID # CSOzturk
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date October 10, 2022

Study information

Verified date December 2022
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date October 10, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
"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

Locations

Country Name City State
Turkey Gazi University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from Baseline level of Spielberger State-Trait Anxiety to 2 months (change is being assessed)]
Primary 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 Change from Baseline level of Maternal Attachment Scale at 2 months (change is being assessed)].
Primary 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. Change from Baseline level of Postnatal Breastfeeding Self-Efficacy Scale at 2 months (change is being assessed)].
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