NCT02909543

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 21, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

September 1, 2016

Last Update Submit

September 18, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

The research data will be conducted by using a semi structured interview of the participants in the study.

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Non Hebrew speakers
  • Did not underwent heart surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe MC,

Hadera, Israel

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 21, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

September 21, 2016

Record last verified: 2016-05

Locations