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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02909543
Other study ID # 51-2016
Secondary ID
Status Recruiting
Phase N/A
First received September 1, 2016
Last updated September 18, 2016
Start date September 2016
Est. completion date October 2017

Study information

Verified date May 2016
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services Research
Study type Observational

Clinical 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., 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date October 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 38 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Non Hebrew speakers

- Did not underwent heart surgery.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Observation and Interviwe
The research data will be conducted by using a semi structured interview of the participants in the study.

Locations

Country Name City State
Israel Hillel Yaffe MC, Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Interview about the life experience of young women (age 18-38) who live with congenital heart disease and overwent an open heart operation. 1day, at the time of the interview Yes