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Clinical Trials/NCT06502730
NCT06502730
Completed
N/A

Nursing Led Interventions: Effect of Creating Opportunities for Parent Empowerment Program on Mother- Infant Interaction, Sense of Competence and Mental Health Outcome.

Matrouh University1 site in 1 country60 target enrollmentJanuary 25, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Empowerment
Sponsor
Matrouh University
Enrollment
60
Locations
1
Primary Endpoint
Parenting Sense of Competency Scale (PSOC)
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of the study is to:

  • Evaluate the effect of creating opportunities for parent empowerment program on maternal sense of competence, mental health outcome and mother-infant interaction.

RESEARCH HYPOTHESES

  • Mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit high level of competence than those who don't.
  • Mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit less stress level than those who don't.
  • Mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit high interaction than those who don't.

The mothers of preterm neonates will be assigned into two equal groups as follows:

  • Study group (group II) mothers of preterm neonates who will receive COPE program.
  • Control group (group I) mothers of preterm neonates who will not receive COPE program.

Detailed Description

* Research Design: A quasi-experimental (pre-posttest) research design will be used. * Setting: The study will be conducted at the Neonatal Intensive Care Unit at Smouha Specialty Hospital in Alexandria. * Subjects: A convenience sampling of 60 mothers of preterm infants who admitted to the previously mentioned setting * During the 1st day of preterm admission to NICU data concerning characteristics of neonates and their mothers' in both groups will be obtained from medical records using tool I. * The pretest will be conducted to the mothers of neonates on the 1st day of admission in the NICU to assess mothers' sense of competence and perceived stress by interviewing them to collect data using tool II, III and mother infant interaction in both groups by observation using tool IV. * After completion of the pretest, the mothers in the study group will receive COPE program, then at the 7th day of the study posttest will be done for both group

Registry
clinicaltrials.gov
Start Date
January 25, 2024
End Date
October 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Matrouh University
Responsible Party
Principal Investigator
Principal Investigator

Seham El-Sayed Saleh Hassan

Assistant Professor of pediatric nursing, faculty of nursing

Matrouh University

Eligibility Criteria

Inclusion Criteria

  • The mother age more than 20 years, educated and has no experience of premature birth
  • The mother has no postpartum discomforts (such as, bleeding, depression or pain
  • Premature neonates( gestational age 37 weeks)
  • Birth weight \< 2500 g or \> 1500 g (LBW)
  • Five-minute Apgar score \> 7
  • Neonate not with any medically restricted conditions (e.g., intraventricular hemorrhage or intracerebral hemorrhage (grades III and IV).
  • Neonate not on ant ventilation assisted devices, such as ventilator or CPAP

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Parenting Sense of Competency Scale (PSOC)

Time Frame: 7 days

This scale was developed by Gibaud-Wallston \& Wandersman, 1978, the Chinese version of the PSOC Scale (C-PSOC) to assess the mothers' sense of competence and satisfaction with parenting. The C-PSOC includes 17 items.

Parent-Infant Interaction Observation (PIIO) Checklist:

Time Frame: 7 days

It is an observational Scale developed by (Svanberg, et al., 2013), It is a screening tool for parent-infant interactions for infant aged from 0-6 months. It includes 13 interactional items such as: Infant positioning, eye contact, vocalizations, affect engagement and synchrony, warmth and affection, holding and handling, verbal commenting (mind- mindedness), attunement/ harmony to distress, bodily intrusiveness, expressed expectations, empathic understanding, responsive turn taking, and baby's self-soothing strategies.

Modified Parental Stressor Scale (PSS): NICU

Time Frame: 7 days

This scale was developed by (Miles et al. 1993). It is used to assess perceived stress of mothers with preterm infants during the NICU hospitalization of their infant. The PSS:NICU is a 50-item self-report scale that measures parental stress related to four dimensions of the NICU environment: sights and sounds in the NICU (5 items); the infant's appearance (21 items); staff behaviors and communication (13 items), and parent interaction with baby (11 items).

Study Sites (1)

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