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Early Mother-Baby AttachmentNCT04916301

Early Period Mother-Infant Attachment Indicators

An observational study of Early Mother-Baby Attachment, run by Sakarya University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to develop The Scale for Evaluating Early Mother-Baby Attachment Indicators and to examine its validity and reliability.This is a cross-sectional, methodological, descriptive, and correlational study.The sample of the study for analysis was planned to consist of 130 mothers..The content… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Early Mother-Baby Attachment
What is being tested?
Early Mother-Infant Attachment
How many people
130 participants
Where
No sites listed yet
Study dates
1 Jun 2021to 1 Jul 2021
Phase
Observational
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 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: 130 volunteer mothers

Who may be able to join

  • The inclusion criteria were as follows: the participants had to be over 18 years old, had to have volunteered to participate in the study, had to have no health problems related to the newborn, and had to be the mother or the primary care provider.

Who cannot join

  • the participants had not to have volunteered to participate in the study, had to have health problems related to the newborn, and had not to be the mother or the primary care provider.

Trial locations and contacts

No sites are listed yet.

özge Karakaya Suzan, res. asist. contact

+90 264 295 4341

ozgekarakayasuzan@sakarya.edu.tr

About this study

Official title: Developing a Scale for the Psychometric Evaluation of Early Period Mother-Infant Attachment Indicators

The purpose of this study is to develop The Scale for Evaluating Early Mother-Baby Attachment Indicators and to examine its validity and reliability.This is a cross-sectional, methodological, descriptive, and correlational study.The sample of the study for analysis was planned to consist of 130 mothers..The content validity of the scale will assessed by consulting 13 experts in pediatrics, psychiatry and women's health.After the contents of the scale were verified, a pilot test will conducted with a draft scale consisting of 13 items.After the analyzes to be made, it will be tested whether it is a validite and reliable measurement scale.

Read the detailed description

The behavior of the mother toward her baby in the mother-baby encounter after the birth provides important clues about the bonding process between the mother and the baby in the later period. Therefore, it is important for the nurse responsible for the care of the newborn to carefully observe the mother's behavior to identify the emotional bond between the mother and the baby.Therefore, there is a need for a measurement tool to be developed to be used in the evaluation of early mother-infant attachment, which covers the postnatal period. This scale can enable healthcare professionals to quickly and easily evaluate mother-infant attachment behavior in the early postnatal period. Thus, it can contribute to the early identification of negative attachment behavior that may develop in the future and allow nurses to provide the necessary support. The purpose of this study is to develop The Scale for Evaluating Early Mother-Baby Attachment Indicators and to examine its validity and reliability.

Design and Method Aim This study aims to develop a tool to measure Early Mother-Infant Attachment Indicators and test them psychometrically.

Study Design This is a cross-sectional, methodological, descriptive, and correlational study.

Methodology The development of The Scale for Evaluating Early Mother-Baby Attachment Indicators, the design of the scale, and the phases in its validity are shown in Figure 1. These items include: (1) the preparation and scoping phase; (2) the development of the questionnaire items and rating scale; (3) the content validity; and (4) the pilot study (psychometric evaluation).

Sample/Participants This study will carried out in the XXXX Training and Research Hospital Maternity Service-Infant Team between june and july of 2021. Participants will selected by the random sampling method. The literature states that the number of samples should be at least five times the number of scale items-ideally 10 times the number of items when developing a scale. The number of items in the scale is 13. Accordingly, the study for analysis was planned to consist of 130 mothers. The inclusion criteria were as follows: the participants had to be over 18 years old, had to have volunteered to participate in the study, had to have no health problems related to the newborn, and had to be the mother or the primary care provider.

Data Collection Tools The Sociodemographic Form This form will completed by the mothers while they were in the hospital. It consists of 26 questions about age, the number of children, the maternal educational level, the income levels of the families, and satisfaction with having a baby.

The Scale for Evaluating Early Mother-Baby Attachment Indicators The scale consists of 13 items showing physical and emotional intimacy, exploration, and striving.The content validity of the scale will assessed by consulting 11 experts in pediatrics, psychiatry and women's health.After the contents of the scale were verified, a pilot test will conducted with a draft scale consisting of 13 items Research experts were sent a draft of the Scale for Evaluating Early Mother-Baby Attachment Indicators and a content validity index (CVI) rating form. They were asked to rate the relevance of each item. Relevance was rated on a three-point scale: 1 = not at all relevant, 2 = need to be fixed, 3 = highly relevant. The experts were also encouraged to add comments to each item and to make suggestions for any other item that they deemed necessary but was missing from the instrument. The CVI rating form was created in congruence with best practices for the development of such forms. Rich reviews from experts provided sufficient data for content review. Based on the analysis of the completed CVI forms and the research experts' comments, two scale items were revised.

Being tested
Early Mother-Infant Attachment
Keywords
Attachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Mother-Infant AttachmentBehavioural

    Early Mother-Infant Attachment Indicators will be observed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Early Mother-Infant Attachment Scale.

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2021
  2. Study start1 Jun 2021 (estimated)
  3. Primary completion1 Jul 2021 (estimated)
  4. Study completion1 Jul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Family based
Time perspective
Cross-sectional
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04916301
Sponsor's protocol ID
developing scale
Status last verified
Jun 2021
First submitted
1 Jun 2021
Last updated
7 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Early Mother-Baby Attachment, run by Sakarya University.

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 1 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: status not confirmed, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact özge Karakaya Suzan, res. asist. (+90 264 295 4341, ozgekarakayasuzan@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Early Mother-Infant Attachment Scale. (time frame: one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Jun 2021.

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