Stress, PsychologicalNCT05214248
Multimedia Admission Orientation in NICU
A study testing a multimedia admission orientation in people with Stress, Psychological and Preterm Infants, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Preterm Infants, Intensive Care Units, Neonatal
- What is being tested?
- a multimedia admission orientation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Aug 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Cathay General Hospital
Taipei, 112
Kai-Wei K. Wang, Ph.D., 886228227101 ext. 3150, kaiwei@ntunhs.edu.tw
Fu-Ching Hsu, BSN, 886983755082, fuching19930816@gmail.com
About this study
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
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.
Read the 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.
- Being tested
- a multimedia admission orientation
- Keywords
- Neonatal Intensive Care Unit, Admission Orientation, Multimedia Education, Parental, Parental Uncertainty, Quasi-Randomized Controlled Trial
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a multimedia admission orientationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: a multimedia admission orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: first day of admission (first_baseline), 48~72 hours after admission (second data collection), and transfer out of NICU (third data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start31 Aug 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Cathay General Hospital
- Responsible party
- Principal investigator, Kai-Wei Katherine Wang, National Taipei University of Nursing and Health Sciences
- Investigators
- Kai-Wei K. Wang, Ph.D., Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214248
- Sponsor's protocol ID
- CGH-P110036
- Status last verified
- Jan 2022
- First submitted
- 30 Aug 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05214248
- Acronym / sponsor ID
- CGH-P110036
- Keywords
- Neonatal Intensive Care Unit, Admission Orientation, Multimedia Education, Parental, Parental Uncertainty, Quasi-Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Cathay General Hospital
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multimedia admission orientation | Experimental | Other: a multimedia admission orientationMultimedia 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a multimedia admission orientationA 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. | Other | multimedia admission orientation |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai-Wei K. Wang, Ph.D. principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a multimedia admission orientation in people with Stress, Psychological and Preterm Infants, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai-Wei K. Wang, Ph.D. (886228227101 ext. 3150, kaiwei@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.