NCT05594836

Brief Summary

The research is a randomized controlled experimental study. The study includes primiparous mothers hospitalized in the Obstetrics and Gynecology Service of Recep Tayyip Erdogan University Training and Research Hospital between 01/12/2022-01/10/2023. The population of the study will be composed of primiparous mothers hospitalized in the Obstetrics and Gynecology Service of Recep Tayyip Erdoğan University Training and Research Hospital between 01/12/2022 and 01/10/2023. All mothers who were hospitalized in the gynecology service during the data collection period and met the inclusion criteria will be included in the study and sample selection will not be made. "Mother and Baby Descriptive Information Form", "Maternal Attachment Scale", "Postpartum Breastfeeding Self-Efficacy Scale-Short Form", "Semantic Difference Scale-Me as Mother" and "Sleep and Crying Diary" will be used to collect research data. Developing the 5S application, which is a baby calming technique, as an educational material in the research. A training booklet will be prepared and used by making use of the training materials that Harvey Karp shared with the researchers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

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

Study Start

First participant enrolled

October 19, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

October 20, 2022

Last Update Submit

March 6, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Maternal Attachment Scale

    The highest level of attachment occurs when the mother understands the baby's signs and symptoms and meets the baby's physical and emotional needs. A mother's loving attachment to her baby, that is, maternal attachment, is one of the most important elements that promotes the healthy growth and development of the child. MBI was developed in 1994. MDS is a 4-point Likert-type scale that includes 26 items and is answered between always (4 points) and never (1 point). An overall score is obtained from the sum of all items. The lowest score that can be obtained from the scale is 26, and the highest score is 104. A high score indicates high maternal attachment. The validity and reliability of the scale for Turkish society was carried out in 2009 and it was determined that it would be suitable for mothers who have babies between one and four months after birth.

    9 MONTHS

  • Postpartum Breastfeeding Self-Efficacy Scale-Short Form

    It was developed in 1999 to evaluate mothers' breastfeeding self-efficacy levels. The first version of the scale consists of 33 items. Later, in 2003, a 14-item short form of the scale was developed. It is easier to apply and evaluates self-efficacy correctly. The Breastfeeding Self-Efficacy Short Form is a five-point Likert-type scale (1= "I am not sure at all" and 5 = "I am always sure"). The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The higher the score, the higher the breastfeeding self-efficacy. The Turkish validity and reliability study of the scale was carried out in 2010.

    9 MONTHS

  • Semantic Difference Scale-Me as Mother

    This scale measures the evaluation dimensions of the concept of "myself as a mother". The scale consists of 11 semantic pairs of opposite adjectives with 11 items and 7 points. These 11 items are distributed within the 22 item opposite adjective pairs in the scale. Three items were evaluated with reverse scoring to prevent the participant from being biased while responding. The third, seventh, and eighth items were evaluated over "one" point instead of "seven" point. High total scores indicate positive maternal self-assessment. The scale was adapted to Turkish society in 2003.

    9 MONTHS

Study Arms (2)

Training

EXPERIMENTAL

Perception of Maternal Role, Maternal Attachment and Breastfeeding Self-Efficacy

Behavioral: Infant Calming Training

control

NO INTERVENTION

not Perception of Maternal Role, Maternal Attachment and Breastfeeding Self-Efficacy

Interventions

Perception of Maternal Role, Maternal Attachment and Breastfeeding Self-Efficacy during Infant Calming Training

Training

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Maternal criteria;
  • Being primiparous
  • Being over 18 years old
  • Being literate
  • Absence of multiple pregnancy
  • Volunteering to participate in the research
  • Being open to communication and interaction
  • Owning a smartphone (for education group - white noise) Criteria for the baby;
  • Being older than 37 weeks of gestation
  • Normal birth weight (between 2500-4000 g)
  • Absence of a medical condition that would prevent sucking

You may not qualify if:

  • Admission of the baby to the intensive care unit
  • The presence of a chronic disease in the mother that will prevent baby care
  • Having any diagnosed disease of the baby during the study
  • Artificial feeding of the baby

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Nursing of Faculty

Erzurum, Center, 25240, Turkey (Türkiye)

Location

Study Officials

  • ARZU SARIALİOĞLU, PHD

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 26, 2022

Study Start

October 19, 2022

Primary Completion

December 27, 2023

Study Completion

March 6, 2024

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED

Locations