Clinical trial NCT06502730: COPE Program , Mental Health, Mother- Infant Interaction, Sense of Competence
Official title: Nursing Led Interventions: Effect of Creating Opportunities for Parent Empowerment Program on Mother- Infant Interaction, Sense of Competence and Mental Health Outcome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Empowerment
Competence
Outcome
Interaction
Keywords: COPE;
Maternal Competence;
Maternal Mental Health;
Parent-Infant Interaction;
Preterm neonates
Lead sponsor: Matrouh University
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2024-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 34
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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:

-

Primary outcomes:
measure: Parenting Sense of Competency Scale (PSOC)
timeFrame: 7 days
measure: Modified Parental Stressor Scale (PSS): NICU
timeFrame: 7 days
measure: Parent-Infant Interaction Observation (PIIO) Checklist:
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mersa Matruh
country: Egypt
facility: Matrouh university
Study officials:
affiliation: Matrouh University
name: Seham Saleh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibaud-Wallston J, Wandersman LP. Parenting sense of competence scale. 1978. https://researchingparents.wordpress.com/2013/02/15/parentingsense- of-competence-psoc/
citation: Jnaneswari. K, Dr. Manjubala Dash. Effect of COPE Program (Creating Opportunities for Parent Empowerment) on Maternal Stress and Parent Neonate Interaction among NICU Mothers. Archives of Reproductive Medicine and Sexual Health. 2020; 3(1): 16-23.
citation: Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
citation: P.O. Svanberg, J. Barlow & W. Tigbe (2013) The Parent-Infant Interaction Observation Scale: reliability and validity of a screening tool, Journal of Reproductive and Infant Psychology, 31:1, 5-14, DOI: 10.1080/02646838.2012.751586