Congenital Heart DefectNCT06172608
Effect of Educational Program on Parental Stress of Parents of Children With CHD
A study testing psychoeducational intervention in people with Congenital Heart Defect, run by Zhengzhou University at 1 site in China.
Trial summary
Congenital Heart disease accounts for about one third of the all congenital anomalies. In last decades' huge advancements occurred in treatment and diagnosis. More and more surgeries are being done which causes stress in parents and affects their mental health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Defect
- What is being tested?
- psychoeducational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2024to 30 Apr 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parents of children with congenital heart disease
- Patient is scheduled for elective cardiac surgery and not had any surgery before.
- Willing to participate in the study
Who cannot join
- Parents of CHD who have other critical conditions along with CHD
- Parents able to understand local languages (Urdu and Pashto)
Trial locations and contacts
1 site in 1 country.
China1 site
Zhengzhou University,
Zhengzhou, Henan, 450000
Zhang Wei Hong, PhD, 18638127788, zwhong306@zzu.edu.cn
About this study
Official title: Effect of Educational Program on Parental Stress of Parents of Children With Congenital Heart Disease Undergoing Cardiac Surgery: Quasi Experimental Study
Congenital Heart disease accounts for about one third of the all congenital anomalies. In last decades' huge advancements occurred in treatment and diagnosis. More and more surgeries are being done which causes stress in parents and affects their mental health. Some studies have reported that about one third of the parents of children with CHD remain in stress even after surgery is being done. The goal of this trial is to evaluate effect of educational intervention on mental health of parents of children with congenital heart disease undergoing cardiac surgery compared to the parents who get usual care and pamphlets of the same information.
The investigators are including parents of children with CHD who are already diagnosed with CHD and are undergoing cardiac surgery.
- Conditions
- Congenital Heart Defect
- Being tested
- psychoeducational intervention
- Keywords
- Congenital Heart disease, parental stress
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducational interventionOther
. Intervention group (I) will receive psychosocial education which will be consist of two parts. 1) Face to Face 2) Community based intervention.
- Face to face: This face to face session will be consisting of 30-minute session soon after inclusion into the study. A leaflet consisting of all information will be provided to all the patents taking part in the study.
- Community Based Intervention: In community based interventions prerecorded videos about all the topics covered in face to face session will be made available to parents via a secure online platform. Parents can easily browse it easily when they need it. These videos will be recorded in local language (Urdu), which is easy to understand for almost all the people.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (I) | Experimental | Intervention group (I) will be receiving a psychoeducational intervention along with routine care they are getting in the hospital Receives: Other: psychoeducational intervention |
| Control group (C) | No intervention | Comparison usual care and Leaflet of the information. At the end of the trial these also get the video and educational sessions as intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental stress in parents of children with congenital Heart disease
Stress changes will be measured via Parental Stress Scale (PSS). The PSS is scored by summing the scores for all 18 items. The total score can range from 18 to 90, with higher scores indicating higher levels of parental stress. The PSS also has two subscales: Child Demandingness (CD) and Parental Competence (PC). PSS scores are interpreted based on the following ranges: 18-37 low stress, 38-56 Moderate stress and 57-90 as high stress.
Measured: [Time Frame: INTERVENTION group (I) Baseline (beginning of the study); at 1 day of discharge time and 12 weeks after discharge from hospital].
Secondary outcomes (1)
Changes on parental QoL
Changes on parental quality of life will be assessed through World Health Organization Quality of Life-Bref (WHOQOL-Bref). The WHOQOL-Bref instrument is composed by 26 items, which are organized in 4 specific domains: Physical (7 items), Psychological (6 items), Social Relationships (3 items), Environment (8 items) and a general QoL facet (2 items). All items are quoted from 1 to 5. Three items, related to questions posed negatively (Q3, Q4 and Q26), must be reversed (the calculation implies the subtraction of their value to six units). The results are transformed on a scale of 0 to 100. Each domain score is computed through the formula: [(sum of all items - number of items) / (4x number of items)] x 100. Higher scores correspond to better quality of life.
Measured: [ Time Frame: INTERVENTION group - Baseline (beginning of the study); at 1 day of time of discharge and 12 weeks after intervention. CONTROL group - baseline; at time of discharge and 12 weeks after intervention.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start30 Jan 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAMAYUN KHAN, Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172608
- Sponsor's protocol ID
- 2023-296
- Status last verified
- Jan 2024
- First submitted
- 29 Nov 2023
- Last updated
- 24 Jan 2024
- 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 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Educational Program on Parental Stress of Parents of Children With Congenital Heart Disease Undergoing Cardiac Surgery: Quasi Experimental Study
- ClinicalTrials.gov ID
- NCT06172608
- Acronym / sponsor ID
- 2023-296
- Conditions
- Congenital Heart Defect
- Keywords
- Congenital Heart disease, parental stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 15 Dec 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.
Congenital Heart disease accounts for about one third of the all congenital anomalies. In last decades' huge advancements occurred in treatment and diagnosis. More and more surgeries are being done which causes stress in parents and affects their mental health. Some studies have reported that about one third of the parents of children with CHD remain in stress even after surgery is being done. The goal of this trial is to evaluate effect of educational intervention on mental health of parents of children with congenital heart disease undergoing cardiac surgery compared to the parents who get usual care and pamphlets of the same information.
The investigators are including parents of children with CHD who are already diagnosed with CHD and are undergoing cardiac surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (I) | Experimental | Other: psychoeducational interventionIntervention group (I) will be receiving a psychoeducational intervention along with routine care they are getting in the hospital |
| Control group (C) | No intervention | –Comparison usual care and Leaflet of the information. At the end of the trial these also get the video and educational sessions as intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parents of children with congenital heart disease
- Patient is scheduled for elective cardiac surgery and not had any surgery before.
- Willing to participate in the study
Key exclusion criteria (2 listed)
- Parents of CHD who have other critical conditions along with CHD
- Parents able to understand local languages (Urdu and Pashto)
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 |
|---|---|---|
| psychoeducational intervention. Intervention group (I) will receive psychosocial education which will be consist of two parts. 1) Face to Face 2) Community based intervention. 1. Face to face: This face to face session will be consisting of 30-minute session soon after inclusion into the study. A leaflet consisting of all information will be provided to all the patents taking part in the study. 2. Community Based Intervention: In community based interventions prerecorded videos about all the topics covered in face to face session will be made available to parents via a secure online platform. Parents can easily browse it easily when they need it. These videos will be recorded in local language (Urdu), which is easy to understand for almost all the people. | Other | Intervention Group (I) |
Primary outcome
Parental stress in parents of children with congenital Heart disease
Time frame: [Time Frame: INTERVENTION group (I) Baseline (beginning of the study); at 1 day of discharge time and 12 weeks after discharge from hospital].
Stress changes will be measured via Parental Stress Scale (PSS). The PSS is scored by summing the scores for all 18 items. The total score can range from 18 to 90, with higher scores indicating higher levels of parental stress. The PSS also has two subscales: Child Demandingness (CD) and Parental Competence (PC). PSS scores are interpreted based on the following ranges: 18-37 low stress, 38-56 Moderate stress and 57-90 as high stress.
1 secondary outcome
Changes on parental QoL
Time frame: [ Time Frame: INTERVENTION group - Baseline (beginning of the study); at 1 day of time of discharge and 12 weeks after intervention. CONTROL group - baseline; at time of discharge and 12 weeks after intervention.]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducational intervention in people with Congenital Heart Defect, run by Zhengzhou University at 1 site in China.
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 2 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 24 Jan 2024. 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 China. 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 HAMAYUN KHAN (16638144502, hamayunkhn1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental stress in parents of children with congenital Heart disease (time frame: [Time Frame: INTERVENTION group (I) Baseline (beginning of the study); at 1 day of discharge time and 12 weeks after discharge from hospital].). 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 24 Jan 2024.