NCT05199298

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

January 1, 2022

Last Update Submit

December 11, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)]

  • 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)].

  • 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)].

Study Arms (2)

"Mandala Activity-Based Breastfeeding Program"

EXPERIMENTAL

The group receiving Mandala Activity-Based Breastfeeding Program

Other: "Mandala Activity-Based Breastfeeding Program"

Control group

NO INTERVENTION

the group that did not receive any training/initiative

Interventions

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

"Mandala Activity-Based Breastfeeding Program"

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • pregnant women and infants with health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Cigdem Sarı Ozturk-Principal Investigator

Study Record Dates

First Submitted

January 1, 2022

First Posted

January 20, 2022

Study Start

August 1, 2022

Primary Completion

September 30, 2022

Study Completion

October 10, 2022

Last Updated

December 13, 2022

Record last verified: 2022-12

Locations