Women With Congenital Heart DiseasesNCT02909543
The Life Experience of Young Women (Age 18-38) Who Live With Congenital Heart Disease
An observational study of Women With Congenital Heart Diseases, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
This research will focus on young women between the ages of 18-38 who underwent a heart operation and their life experiences. This research will focus on these life events and the paradigm of these women being raised as "heart sick," and consequently lacking self-esteem (Frigiola, Bull, \& Wray, 2014; Hickey et al.… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Women With Congenital Heart Diseases
- What is being tested?
- Observation and Interviwe
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2016to Oct 2017
- Phase
- Observational
- 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 to 38 years
- Women only
- No healthy volunteers
- Adult
Study population: This study aims to focus on women's stories about their life experiences and the influence of surgery(ies) on their daily life using an the qualitative phenomenological approach.
Who may be able to join
- Atrial septal defect or ASD,
- Ventricle septal defect or VSD,
- Tetralogy of Fallot or TOF
- Translocation of great arteries or TGA
- underwent heart operation
- Hebrew speakers that are able to understand the meanings of the questions and tell their life stories.
Who cannot join
- Non Hebrew speakers
- Did not underwent heart surgery.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hillel Yaffe MC,
Hadera
Michael Feldman, Dr., 0506246729, feldman@hy.health.gov.il
Albina Librich Rabinovich, MA, 0542557955, albinka6488@gmail.com
About this study
This research will focus on young women between the ages of 18-38 who underwent a heart operation and their life experiences. This research will focus on these life events and the paradigm of these women being raised as "heart sick," and consequently lacking self-esteem (Frigiola, Bull, \& Wray, 2014; Hickey et al., 2012). Most qualitative studies focusing on the quality of life compare men and women, completely ignoring women's body image and the experience of womanhood (Hickey et al., 2012; Hövels-Gürich et al., 2007; Sarikouch, et al., 2013). This study aims to focus on women's stories about their life experiences and the influence of surgery(ies) on their daily life using an the qualitative phenomenological approach.
- Conditions
- Women With Congenital Heart Diseases
- Being tested
- Observation and Interviwe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation and InterviweOther
The research data will be conducted by using a semi structured interview of the participants in the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview about the life experience of young women (age 18-38) who live with congenital heart disease and overwent an open heart operation.
Measured: 1day, at the time of the interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Congenital Heart DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909543
- Sponsor's protocol ID
- 51-2016
- Status last verified
- May 2016
- First submitted
- 1 Sep 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Life Experience of Young Women (Age 18-38) Who Live With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02909543
- Acronym / sponsor ID
- 51-2016
- Conditions
- Women With Congenital Heart Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 21 Sep 2016 (estimated)
- 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.
This research will focus on young women between the ages of 18-38 who underwent a heart operation and their life experiences. This research will focus on these life events and the paradigm of these women being raised as "heart sick," and consequently lacking self-esteem (Frigiola, Bull, \& Wray, 2014; Hickey et al., 2012). Most qualitative studies focusing on the quality of life compare men and women, completely ignoring women's body image and the experience of womanhood (Hickey et al., 2012; Hövels-Gürich et al., 2007; Sarikouch, et al., 2013). This study aims to focus on women's stories about their life experiences and the influence of surgery(ies) on their daily life using an the qualitative phenomenological approach.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study aims to focus on women's stories about their life experiences and the influence of surgery(ies) on their daily life using an the qualitative phenomenological approach.
Key inclusion criteria (6 listed)
- Atrial septal defect or ASD,
- Ventricle septal defect or VSD,
- Tetralogy of Fallot or TOF
- Translocation of great arteries or TGA
- underwent heart operation
Key exclusion criteria (2 listed)
- Non Hebrew speakers
- Did not underwent heart surgery.
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 |
|---|---|---|
| Observation and InterviweThe research data will be conducted by using a semi structured interview of the participants in the study. | Other | – |
Primary outcome
Interview about the life experience of young women (age 18-38) who live with congenital heart disease and overwent an open heart operation.
Time frame: 1day, at the time of the interview
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
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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?
An observational study of Women With Congenital Heart Diseases, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 6 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 21 Sep 2016. 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 Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interview about the life experience of young women (age 18-38) who live with congenital heart disease and overwent an open heart operation. (time frame: 1day, at the time of the interview). 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 21 Sep 2016.