NCT05789836

Brief Summary

The aim of the study is to examine the effect of including mothers with newborn babies in surgical intensive care units during the nursing care process on mother's self-confidence and mother-infant attachment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 16, 2023

Last Update Submit

March 29, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Taylor Mother-Infant Attachment Scale

    The answers consisting of four options are scored between 0-3, the lowest score that can be obtained from the scale is 0 and the highest score is 24.

    6 month

  • Pharis Self-Confidence Scale

    The Pharis Self-Confidence Scale, a 13-item, five-point measurement tool, measures a parent's feelings of self-confidence about daily baby care. Each infant care item is rated from 1 (not at all) to 5 (completely). High total score results indicate high self-confidence in babysitting.

    6 month

  • Care Participation Assessment Scale

    Care practices of mothers are evaluated as Yes-No and scored as 1-0. Although the maximum score that can be obtained from the scale is 19, an increase in the score means that participation in care has dropped.

    6 month

Study Arms (1)

Study Group

EXPERIMENTAL

This research was planned as a single group pretest-posttest quasi-experimental.

Other: Nursing care

Interventions

Involving the mother in nursing care

Study Group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMother
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatient treatment of the baby in the surgical neonatal intensive care unit without the mother's presence since birth
  • The mother stays with the baby for at least 4 days in the post-operative period
  • The mother does not have any communication and language problems
  • The mother's willingness to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, Eyalet/Yerleşke, 60200, Turkey (Türkiye)

Location

Related Publications (2)

  • Karakulak HA, Alparslan, Ö. Anne-bebek Bağlanma Ölçeğinin Türk Toplumuna Uyarlanması: Aydın Örneği. Çağdaş Tıp Dergisi. 2016; 6(3), 188-199.

    RESULT
  • Karaçam Z, Çakmak E, Yenidoğan Yoğun Bakım Ünitesinde Bebeği Yatan Anneler İçin Bakıma Katılımı Değerlendirme Ölçeği: Ölçek Geliştirme, Geçerlilik ve Güvenilirliği. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi. 2018; 21(2), 69-78.

    RESULT

MeSH Terms

Interventions

Nursing Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mukaddes Demir Acar

    Tokat Gaziosmanpasa University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This research was planned as a single group pretest-posttest quasi-experimental.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

March 16, 2023

First Posted

March 29, 2023

Study Start

April 1, 2022

Primary Completion

September 30, 2022

Study Completion

August 1, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations