Educational VideosNCT05496803
Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization.
A study testing routine education plus digital video disk and routine education in people with Educational Videos and Catheterization, run by Chung Shan Medical University Hospital at 1 site in Taiwan.
Trial summary
To examine if adding educational digital video disk to routine education can reduce parental uncertainty and anxiety more if their children undergo congenital heart disease catheterization and when catheterization or post- catheterization complications occur. Read more about this study
- Who is it for?
- Ages 20 to 48 years
- Conditions the study is for
- Educational Videos, Catheterization, Congenital Heart Disease in Children
- What is being tested?
- routine education plus digital video disk and routine education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Jul 2022to 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 to 48 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Parents whose children underwent first elective cardiac catheterization for congenital heart disease
- Parents should have been the primary caregivers
- Parents able to communicate effectively, either orally or in writing
Who cannot join
- Parents of children with genetic disorders
- Parents of children with non-cardiac congenital anomalies
- Parents of children with diseases such as cerebral palsy, epilepsy, psychiatric diseases, and chronic lung diseases
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University Hospital.
Taichung
Shu-Juan Liu
About this study
Official title: Chung Shan Medical University Hospital
To examine if adding educational digital video disk to routine education can reduce parental uncertainty and anxiety more if their children undergo congenital heart disease catheterization and when catheterization or post- catheterization complications occur. We want to know, compared to only routine education, if adding digital video disk could decrease parental uncertainty or anxiety more or not.
Read the detailed description
Aims and objectives: To examine if adding educational digital video disk to routine education can reduce parental uncertainty and anxiety more if their children undergo congenital heart disease catheterization and when catheterization or post- catheterization complications occur.
Background: Parents experience uncertainty and anxiety when their children undergo conditions mentioned above.
Design: A randomized control-group pretest-posttest design. Methods: In a teaching hospital, 50 fathers and 50 mothers whose children (n=50) underwent first elective catheterization for congenital heart disease were randomly divided into group 1: 25 fathers and 25 mothers receiving routine education plus digital video disk before catheterization; and group 2: 25 fathers and 25 mothers receiving routine education before catheterization. Between groups, parental uncertainty and anxiety levels were compared (1) before education, (2) after education (before catheterization) and (3) on the discharge day (after catheterization). Among mothers whose children had catheterization or post- catheterization complications, the effect of watching the digital video disk on uncertainty and anxiety at discharge day was evaluated.
- Conditions
- Educational Videos, Catheterization, Congenital Heart Disease in Children, Parental Uncertainty, Parental Anxiety
- Being tested
- routine education plus digital video disk, routine education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine education plus digital video diskOther
Parents receiving routine education plus digital video disk before their children receiving congenital heart disease catheterization. The DVD content was the same as the routine education but was presented audio-visually, and the video was easy to understand by the general public.
routine educationOther
Parents receiving routine education before their children receiving congenital heart disease catheterization
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | parents receiving routine education plus digital video disk before catheterization:pre-catheterization educational videos plus routine education Receives: Other: routine education plus digital video disk |
| control group | Other | parents receiving routine education: pre-catheterization routine education Receives: Other: routine education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of parental uncertainty
The scores of parental uncertainty between "routine education" and "routine plus DVD education" groups.
parent's perception uncertainty in illness score was used to evaluate the number scores of anxiety.
Measured: day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)
The change of parental anxiety 1
The number scores of parental anxiety between "routine education" and "routine plus DVD education" groups.
State Anxiety Inventory was used to evaluate the number scores of anxiety.
Measured: day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)
The change of parental anxiety 2
The number scores of parental anxiety between "routine education" and "routine plus DVD education" groups.
Beck Anxiety Inventory was used to evaluate the number scores of anxiety.
Measured: day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start27 Jul 2022
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational VideosStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chung Shan Medical University Hospital, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496803
- Sponsor's protocol ID
- CS2-22078
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chung Shan Medical University Hospital
- ClinicalTrials.gov ID
- NCT05496803
- Acronym / sponsor ID
- CS2-22078
- Conditions
- Educational Videos, Catheterization, Congenital Heart Disease in Children, Parental Uncertainty, Parental Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chung Shan Medical University HospitalUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 11 Aug 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.
To examine if adding educational digital video disk to routine education can reduce parental uncertainty and anxiety more if their children undergo congenital heart disease catheterization and when catheterization or post- catheterization complications occur. We want to know, compared to only routine education, if adding digital video disk could decrease parental uncertainty or anxiety more or not.
Detailed description
Aims and objectives: To examine if adding educational digital video disk to routine education can reduce parental uncertainty and anxiety more if their children undergo congenital heart disease catheterization and when catheterization or post- catheterization complications occur.
Background: Parents experience uncertainty and anxiety when their children undergo conditions mentioned above.
Design: A randomized control-group pretest-posttest design. Methods: In a teaching hospital, 50 fathers and 50 mothers whose children (n=50) underwent first elective catheterization for congenital heart disease were randomly divided into group 1: 25 fathers and 25 mothers receiving routine education plus digital video disk before catheterization; and group 2: 25 fathers and 25 mothers receiving routine education before catheterization. Between groups, parental uncertainty and anxiety levels were compared (1) before education, (2) after education (before catheterization) and (3) on the discharge day (after catheterization). Among mothers whose children had catheterization or post- catheterization complications, the effect of watching the digital video disk on uncertainty and anxiety at discharge day was evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Other: routine education plus digital video diskparents receiving routine education plus digital video disk before catheterization:pre-catheterization educational videos plus routine education |
| control group | Other | Other: routine educationparents receiving routine education: pre-catheterization routine education |
Who may qualify
- Ages
- 20 to 48 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Parents whose children underwent first elective cardiac catheterization for congenital heart disease
- Parents should have been the primary caregivers
- Parents able to communicate effectively, either orally or in writing
Key exclusion criteria (3 listed)
- Parents of children with genetic disorders
- Parents of children with non-cardiac congenital anomalies
- Parents of children with diseases such as cerebral palsy, epilepsy, psychiatric diseases, and chronic lung diseases
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 |
|---|---|---|
| routine education plus digital video diskParents receiving routine education plus digital video disk before their children receiving congenital heart disease catheterization. The DVD content was the same as the routine education but was presented audio-visually, and the video was easy to understand by the general public. | Other | study group |
| routine educationParents receiving routine education before their children receiving congenital heart disease catheterization | Other | control group |
Primary outcome
The change of parental uncertainty
Time frame: day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)
The scores of parental uncertainty between "routine education" and "routine plus DVD education" groups. parent's perception uncertainty in illness score was used to evaluate the number scores of anxiety.
The change of parental anxiety 1
Time frame: day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)
The number scores of parental anxiety between "routine education" and "routine plus DVD education" groups. State Anxiety Inventory was used to evaluate the number scores of anxiety.
The change of parental anxiety 2
Time frame: day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)
The number scores of parental anxiety between "routine education" and "routine plus DVD education" groups. Beck Anxiety Inventory was used to evaluate the number scores of anxiety.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine education plus digital video disk and routine education in people with Educational Videos and Catheterization, run by Chung Shan Medical University Hospital 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 11 Aug 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 Shu-Juan Liu (+886 4 24739595#220801, juan012599@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of parental uncertainty (time frame: day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)). 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 11 Aug 2022.