COVID-19NCT06107491
Preoperative Educational Videos on Maternal Stress Whose Children Received Congenital Heart Disease Surgery: During COVID-19 Panic
A study testing Preoperative educational videos plus routine education and Preoperative routine education in people with COVID-19 and Educational Videos, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
During COVID-19 panic, we examined if educational digital video disk can reduce maternal uncertainty, anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. Read more about this study
- Who is it for?
- Ages 20 to 48 years, women only
- Conditions the study is for
- COVID-19, Educational Videos, Maternal
- What is being tested?
- Preoperative educational videos plus routine education and Preoperative routine education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Oct 2021to 1 Jan 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mothers, whose children underwent first elective cardiac surgery for congenital heart disease
- Mothers should have been the primary caregivers
- Mothers able to communicate effectively, either orally or in writing
Who cannot join
- Mothers of children with genetic disorders
- Mothers of children with non-cardiac congenital anomalies
- Mothers of children with diseases such as cerebral palsy, epilepsy, psychiatric diseases, and * * Mothers of children with chronic lung diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Instructor School of Nursing, Chung Shan Medical University, Taichung, Taiwan
During COVID-19 panic, we examined if educational digital video disk can reduce maternal uncertainty, anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. Compared to only routine education, adding digital video disk could decrease mothers' uncertainty and anxiety more after education, and until the day of discharge. Compared to only routine education, adding digital video disk could decrease mothers' uncertainty and anxiety more on the discharge day if their child had surgical or post-surgical complications.
Read the detailed description
Aims and objectives: During COVID-19 panic, we examined if educational digital video disk can reduce maternal uncertainty, anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur.
Background: Mothers experience uncertainty, anxiety and depression if their children undergo conditions mentioned above. Such stress would be more during COVID-19 panic. Design: A randomized control-group pretest-posttest design. The CONSORT checklist is used. Methods: During COVID-19 panic, in a teaching hospital, 120 mothers whose children underwent first elective surgery for congenital heart disease were randomly divided into group 1: 60 mothers receiving routine education plus digital video disk before surgery; and group 2: 60 mothers receiving routine education. Between groups, mothers' uncertainty, anxiety and depression levels were compared (1) before education, (2) after education (before surgery) and (3) on the discharge day. Among mothers whose children had surgical or post-surgical complications, the effect of watching the digital video disk on uncertainty, anxiety and depression at discharge day was evaluated.
- Conditions
- COVID-19, Educational Videos, Maternal, Uncertainty, Anxiety, Depression
- Being tested
- Preoperative educational videos plus routine education, Preoperative routine education
- Medical subject headings
- COVID-19, Anxiety Disorders, Depression, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative educational videos plus routine educationOther
Mothers receiving routine education plus digital video disk before their children receiving congenital heart disease surgery. The content was the same as the routine education but was presented audio-visually, and the video was easy to understand by the general public.
Preoperative routine educationOther
Mothers receiving routine education before their children receiving congenital heart disease surgery
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | mothers receiving routine education plus digital video disk before surgery Receives: Other: Preoperative educational videos plus routine education |
| control group | Other | mothers receiving routine education Receives: Other: Preoperative routine education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Mother's uncertainty
The number scores of mother's uncertainty between "routine education" and "routine plus DVD education" groups.
Mishel's Parent Perceptions of Uncertainty Scale (PPUS) was used to evaluate the number scores of uncertainty.
Measured: day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)
The change of Mother's anxiety
The number scores of mother's anxiety between "routine education" and "routine plus DVD education" groups.
Beck Anxiety Inventory (BAI) was used to evaluate the number scores of anxiety.
Measured: day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)
The change of Mother's depression
The number scores of mother's depression between "routine education" and "routine plus DVD education" groups.
Beck Depression Inventory (BDI) was used to evaluate the number scores of depression.
Measured: day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start4 Oct 2021
- Primary completion3 Oct 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsai, Principal investigator, Chung Shan Medical University Hospital, Taichiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107491
- Sponsor's protocol ID
- CS1-21113
- Status last verified
- Jan 2023
- First submitted
- 26 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- 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 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instructor School of Nursing, Chung Shan Medical University, Taichung, Taiwan
- ClinicalTrials.gov ID
- NCT06107491
- Acronym / sponsor ID
- CS1-21113
- Conditions
- COVID-19, Educational Videos, Maternal, Uncertainty, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 30 Oct 2023 (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.
During COVID-19 panic, we examined if educational digital video disk can reduce maternal uncertainty, anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. Compared to only routine education, adding digital video disk could decrease mothers' uncertainty and anxiety more after education, and until the day of discharge. Compared to only routine education, adding digital video disk could decrease mothers' uncertainty and anxiety more on the discharge day if their child had surgical or post-surgical complications.
Detailed description
Aims and objectives: During COVID-19 panic, we examined if educational digital video disk can reduce maternal uncertainty, anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur.
Background: Mothers experience uncertainty, anxiety and depression if their children undergo conditions mentioned above. Such stress would be more during COVID-19 panic. Design: A randomized control-group pretest-posttest design. The CONSORT checklist is used. Methods: During COVID-19 panic, in a teaching hospital, 120 mothers whose children underwent first elective surgery for congenital heart disease were randomly divided into group 1: 60 mothers receiving routine education plus digital video disk before surgery; and group 2: 60 mothers receiving routine education. Between groups, mothers' uncertainty, anxiety and depression levels were compared (1) before education, (2) after education (before surgery) and (3) on the discharge day. Among mothers whose children had surgical or post-surgical complications, the effect of watching the digital video disk on uncertainty, anxiety and depression 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: Preoperative educational videos plus routine educationmothers receiving routine education plus digital video disk before surgery |
| control group | Other | Other: Preoperative routine educationmothers receiving routine education |
Who may qualify
- Ages
- 20 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mothers, whose children underwent first elective cardiac surgery for congenital heart disease
- Mothers should have been the primary caregivers
- Mothers able to communicate effectively, either orally or in writing
Key exclusion criteria (3 listed)
- Mothers of children with genetic disorders
- Mothers of children with non-cardiac congenital anomalies
- Mothers of children with diseases such as cerebral palsy, epilepsy, psychiatric diseases, and * * Mothers of children with 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 |
|---|---|---|
| Preoperative educational videos plus routine educationMothers receiving routine education plus digital video disk before their children receiving congenital heart disease surgery. The 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 |
| Preoperative routine educationMothers receiving routine education before their children receiving congenital heart disease surgery | Other | control group |
Primary outcome
The change of Mother's uncertainty
Time frame: day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)
The number scores of mother's uncertainty between "routine education" and "routine plus DVD education" groups. Mishel's Parent Perceptions of Uncertainty Scale (PPUS) was used to evaluate the number scores of uncertainty.
The change of Mother's anxiety
Time frame: day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)
The number scores of mother's anxiety between "routine education" and "routine plus DVD education" groups. Beck Anxiety Inventory (BAI) was used to evaluate the number scores of anxiety.
The change of Mother's depression
Time frame: day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)
The number scores of mother's depression between "routine education" and "routine plus DVD education" groups. Beck Depression Inventory (BDI) was used to evaluate the number scores of depression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- 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.
Tsai principal investigator
Chung Shan Medical University Hospital, Taichiung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative educational videos plus routine education and Preoperative routine education in people with COVID-19 and Educational Videos, run by Chung Shan Medical University 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: finished, as of the sponsor's last update on 30 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Mother's uncertainty (time frame: day 1 (baseline, before education), day 1 (after education), day 5-7 (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 30 Oct 2023.