Multimedia Admission Orientation in NICU

Sponsor
National Taipei University of Nursing and Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05214248
Collaborator
Cathay General Hospital (Other)
132
1
1
23
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: a multimedia admission orientation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
132 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Aug 31, 2021
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: multimedia admission orientation

Multimedia admission orientation for the parents of infants admitted to NICU is provided to the experimental group of the parents. The multimedia orientation based on animation and graphic figures to explain the basic information about the NICU environment and precautions and the essential tests and examination taken for their infant during the initial stage of NICU admission.

Other: a multimedia admission orientation
A short video based on self-drawing characters and figures with Chinese dubbing and background light music, explaining the NICU environment, health care workers, and tests and examination that are essential for an infant admitted to this NICU of Cathay Hospital in Taipei, R.O.C.

Outcome Measures

Primary Outcome Measures

  1. parental stress [first day of admission (first_baseline), 48~72 hours after admission (second data collection), and transfer out of NICU (third data collection)]

    Questionnaire measurement: The Parenting Stress Index-Short Form (PSI-SF) administered in NICU admission, a 5-point Likert-type scale, consisted of 3 dimensions, a total of 36 items. Higher scores mean worse outcome.

  2. parental uncertainty [first day of admission (first_baseline), 48~72 hours after admission (second data collection), and transfer out of NICU (third data collection)]

    Questionnaire measurement: Parents' Perception of Uncertainty Scale (PPUS) modified from Mishel Uncertainty in Illness Scale (MUIS) as developed by Mishel, administered in NICU admission, a 5-point Likert-type scale, consisted of 3 dimensions, a total of 30 items. Higher scores mean worse outcome.

  3. knowledge of admission [first day of admission (first_baseline), 48~72 hours after admission (second data collection), and transfer out of NICU (third data collection)]

    self-developed questionnaire of a knowledge test regarding NICU admission, a 5-point Likert scale (highly agree to highly disagree), a total of 17 items. Higher scores mean better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.
    1. 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
    1. 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.

    1. The primary caregiver who is the care assistant/carer/nanny of the infant who admitted to the NICU.
    1. For those potential caregiver whose infant has congenital abnormality identified by the physician.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cathay General Hospital Taipei Taiwan 112

Sponsors and Collaborators

  • National Taipei University of Nursing and Health Sciences
  • Cathay General Hospital

Investigators

  • Principal Investigator: Kai-Wei K. Wang, Ph.D., National Taipei University of Nursing and Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kai-Wei Katherine Wang, RN, Ph.D., Associate Professor/Director of International Nursing Programs (Postgraduate), National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier:
NCT05214248
Other Study ID Numbers:
  • CGH-P110036
First Posted:
Jan 28, 2022
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kai-Wei Katherine Wang, RN, Ph.D., Associate Professor/Director of International Nursing Programs (Postgraduate), National Taipei University of Nursing and Health Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2022