NCT05214248

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

August 30, 2021

Last Update Submit

January 17, 2022

Conditions

Keywords

Neonatal Intensive Care UnitAdmission OrientationMultimedia EducationParentalParental UncertaintyQuasi-Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

  • parental stress

    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

    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

    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)

Study Arms (1)

multimedia admission orientation

EXPERIMENTAL

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

Interventions

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.

multimedia admission orientation

Eligibility Criteria

Age20 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.
  • \. 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
  • \. For those whose infant needs to use the ventilator in admission.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cathay General Hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Kai-Wei K. Wang, Ph.D.

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai-Wei K. Wang, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, Ph.D., Associate Professor/Director of International Nursing Programs (Postgraduate)

Study Record Dates

First Submitted

August 30, 2021

First Posted

January 28, 2022

Study Start

August 31, 2021

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

January 28, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access
Study Protocol Access
Study Protocol Access
Study Protocol Access
Study Protocol Access
Study Protocol Access

Locations