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Completed

NCT Number: NCT06502730

COPE Program , Mental Health, Mother- Infant Interaction, Sense of Competence

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.

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Key information

Conditions

Empowerment Behavior Competence Interaction Outcome Social Behavior

Age range

34 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Matrouh university

Marsá Maţrūḩ, Egypt

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Creating Opportunities for Parent Empowerment (COPE) Program

Behavioral

It helps to recognize the critical role of parents and encourage taking an active role in their neonate's care, engaging in dyadic interaction with their neonate. COPE program consists of two types of educational information; as teaching parents about normal physical, developmental and behavioral characteristics of their preterm infants and the best ways to interact with them and facilitate their development.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Matrouh University

Other

Collaborators

  • Alexandria University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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