Clinical trial NCT05214248: Multimedia Admission Orientation in NICU
Official title: The Effect of a Multimedia Admission Orientation on the Parental Stress, Uncertainty, and Knowledge of Unit-admission in Primary Caregivers of High-risk Infants in a Neonatal Intensive Care Unit: a Quasi-randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Preterm Infants
Intensive Care Units, Neonatal
Education
Keywords: Neonatal Intensive Care Unit
Admission Orientation
Multimedia Education
Parental
Parental Uncertainty
Quasi-Randomized Controlled Trial
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Cathay General Hospital
First posted: 2022-01-28
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The effect of a multimedia admission orientation on the parental stress, uncertainty, and knowledge of primary caregivers of high-risk infants in a neonatal intensive care unit: a quasi-randomized controlled trial study.

Detailed description: Neonatal Intensive Care Unit (NICU) is the place of caring for high-risk newborns whose primary caregivers would be very stressful due to unfamiliar medical equipment and environment. Furthermore, those primary caregivers of critically ill infants hospitalized in NICU may be even more distress as result of the constraint in visiting time and measures of insolation. Most studies have indicated that those primary caregivers of infants in NICU can experience a high level of parental stress particularly during the initial phase of admission. The literature has reported that during the admission the infant's conditions are prone to be unstable to an extent that can threaten his or her life which can result in the feeling of helplessness, uncertainty, low self-esteem and loss of control in those parents.

The study aims to use a pre- and post-test quasi-randomized controlled trail to examine the effect of Multimedia Orientation Animation of NICU Admission for parents of critically ill infants. The video contain an introduction of common diseases seen in infants in NICU such as respiratory distress and the common medical equipment used and NICU environment. The major purpose of the educational video is to help the primary caregivers understand important information about the newborn's admission to the NICU. The data collection site of the study is one of the NICU from the north medical center in Taiwan. The subjects are grouped by time intervals, and divided into control and experimental groups, and that survey will be collected first with control group who will be provided with regular nursing care in term of admission orientation, and the experiment group is approached after the cessation of data collection from control group, which Multimedia Admission Orientation are offered to the experiment group. The measurements of the study include the caregivers' parental stress, the level of uncertainty and knowledge of admission after being treated by our intervention. The IRB of this study (IRB no.CGH-P110036) has been granted by Cathay General Hospital in Taipei, R.O.C.

Eligibility criteria: Inclusion Criteria of the Primary Caregiver

* 1. Able to listen, speak, write and read Chinese, report of no psychological problems, and agree to give consent and fill out questionnaires of the study.
* 3. The potential caregiver whose infant born within one month and needs to be admitted to the intensive care unit for the first time due to an acute and severe illness
* 4. For those whose infant needs to use the ventilator in admission.

Exclusion Criteria:

* 1.Have a history of mental disorders including depression, cognitive impairment, addiction to smoking or drinking.
* 2. The primary caregiver who is the care assistant/carer/nanny of the infant who admitted to the NICU.
* 3. For those potential caregiver whose infant has congenital abnormality identified by the physician.

Primary outcomes:
measure: parental stress
timeFrame: first day of admission (first_baseline), 48~72 hours after admission (second data collection), and transfer out of NICU (third data collection)
measure: parental uncertainty
timeFrame: first day of admission (first_baseline), 48~72 hours after admission (second data collection), and transfer out of NICU (third data collection)
measure: knowledge of admission
timeFrame: first day of admission (first_baseline), 48~72 hours after admission (second data collection), and transfer out of NICU (third data collection)
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cathay General Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Kai-Wei K. Wang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: