Multimedia Admission Orientation in NICU

Stress, Psychological Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05214248
• Other study ID #: CGH-P110036
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: January 2022
• Source: National Taipei University of Nursing and Health Sciences
• Contact: Kai-Wei K. Wang, Ph.D.
• Phone: 886228227101
• Email: kaiwei[@]ntunhs.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Education
• Intensive Care Units, Neonatal
• Preterm Infants
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Cathay General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences	Cathay General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)