NCT06344663

Brief Summary

Motivational interviewing is a technique used in many fields. No study has been found in national and international databases investigating the effect of motivational interviewing on the perception of insufficient milk, breastfeeding motivation and cortisol level. The study aimed to evaluate the effect of motivational interviews on the perception of insufficient milk, breastfeeding motivation and cortisol level.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

March 25, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2024

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

Same day

First QC Date

March 27, 2024

Last Update Submit

July 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Insufficient Milk Perception Scale (ANN)

    The Insufficient Milk Perception Scale is a scale developed by McCarterSpaulding (2001) to measure mothers' beliefs about whether they produce sufficient milk. It consists of 6 questions. A minimum score of 0 and a maximum score of 50 can be obtained from this scale. A high score indicates that the mother's perception of adequate milk is high

    1 month

Secondary Outcomes (1)

  • Breastfeeding Motivation Scale (EMS)

    1 month

Other Outcomes (1)

  • Visual Analog Scale (VAS)

    1 month

Study Arms (2)

control group

Mothers who will be included in the control group will be interviewed twice in total. Pretest data will be obtained by applying the "Personal Information Form", "Insufficient Milk Perception Scale" and "Breastfeeding Motivation Scale" during the first interview. A sample of the mothers' saliva will be taken to measure cortisol values. Four weeks after the pre-test data are obtained, post-test data will be obtained by applying the "Insufficient Milk Perception Scale" and "Breastfeeding Motivation Scale". Finally, a saliva sample will be taken to check the cortisol value again.

intervention group

Before starting the motivational interviews, pre-test data will be obtained by applying the "Personal Information Form", "Insufficient Milk Perception Scale" and "Breastfeeding Motivation Scale" to the mothers in the intervention group. Afterwards, a sample of the mothers' saliva will be taken to measure their cortisol levels. A total of 4 sessions of motivational interviews will be held for infertile women, 1 session per week for four weeks. At the end of four weeks, post-test data will be obtained by applying the "Insufficient Milk Perception Scale" and "Breastfeeding Motivation Scale". A sample of the mothers' saliva will be taken to measure cortisol levels again.

Other: motivational interview

Interventions

Before starting the interview, mothers will be informed about the interview intervals, duration, how many times it will be held, and that, unlike other interviews, the topic will be determined and the mother's opinions on this subject will be obtained. Each meeting will last approximately 15-30 minutes

intervention group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMothers with the perception of insufficient milk
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Mothers with the perception of insufficient milk

You may qualify if:

  • Those aged 18 and over
  • Those who feed their babies only with breast milk
  • Do you believe that you produce enough milk to feed your baby?" in the Insufficient Milk Perception Scale. Those who answered "No" to the question
  • Having given birth at 37\>gestational weeks
  • Having a baby weighing at least 2500 grams
  • Giving birth vaginally
  • Primiparous

You may not qualify if:

  • Cannot speak Turkish
  • Mothers who did not agree to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eda Sever

Kahramanmaraş, Onikişubat, 46370, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Esra Karataş Okyay

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor lecturer

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 3, 2024

Study Start

March 25, 2024

Primary Completion

March 25, 2024

Study Completion

December 25, 2024

Last Updated

July 9, 2024

Record last verified: 2024-07

Locations