Multimedia Admission Orientation in NICU

January 17, 2022 updated by: Kai-Wei Katherine Wang, National Taipei University of Nursing and Health Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
parental stress
Time Frame: 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.
first day of admission (first_baseline), 48~72 hours after admission (second data collection), and transfer out of NICU (third data collection)
parental uncertainty
Time Frame: 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.
first day of admission (first_baseline), 48~72 hours after admission (second data collection), and transfer out of NICU (third data collection)
knowledge of admission
Time Frame: 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.
first day of admission (first_baseline), 48~72 hours after admission (second data collection), and transfer out of NICU (third data collection)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taipei University of Nursing and Health Sciences

Collaborators

Cathay General Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2021

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

January 17, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 17, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGH-P110036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information comments: Article title: The Lived Experience of Jordanian Parents in a Neonatal Intensive Care Unit: A Phenomenological Study
  2. Study Protocol
    Information comments: Article Title: Stress and feelings in mothers and fathers in NICU: identifying risk factors for early interventions
  3. Study Protocol
    Information comments: Article Title: The effectiveness of early intervention on paternal stress for fathers of premature infants admitted to a neonatal intensive care unit
  4. Study Protocol
    Information comments: Article title: Parental Stress Experience and Age of Mothers and Fathers After Preterm Birth and Admission of Their Neonate to Neonatal Intensive Care Unit; A Prospective Observational Pilot Study
  5. Study Protocol
    Information comments: Article Title: Development and Evaluation of a Video Discharge Education Program focusing on Mother-infant Interaction for Mothers of Premature Infants
  6. Study Protocol
    Information comments: Article Title: Respiratory Distress in the Newborn
  7. Study Protocol
    Information comments: Article Title: Parents' experiences of VOICE: A novel support programme in the NICU
  8. Study Protocol
    Information comments: Article Title: A fathers' group in NICU: Recognising and responding to paternal stress, utilising peer support
  9. Study Protocol
    Information comments: Article Title: Meconium Aspiration Syndrome: An Insight

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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