- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05078996
Treatment-related Quality of Life and Patient-Centred Care With Infertility
September 21, 2023 updated by: Elif Balkan
Patient-Centred Care and Treatment-related Quality of Life With Infertility
This study was conducted in a cross-sectional descriptive type with 160 infertile women who were treated in the IVF Clinic of a university hospital between July - October 2020 in order to evaluate the effect of patient-centered care approach in infertility on treatment-related quality of life.
The data of the study were collected face to face through the "Introductory Information Form" "Patient Centered Care Form for Infertile Women" and "FertiQol Treatment Module".
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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İstanbul, Turkey, 34510
- Elif Balkan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Women who diagnosed with infertility
Description
Inclusion Criteria:
- Diagnosed with infertility
- Has no commnunication problems
Exclusion Criteria:
- Communication problems (e.g language)
- Diagnosed by diseases with reproductive problems but not infertility
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment-related quality of life
Time Frame: from obtaining ethical permission to reaching sampling (approximately 6 months)
|
FertiQol Treatment Module was used to evaluate treatment-related quality of life.
This module is a sub-module within FertiQol Scale which developed by Boivin et al. (2011).
Module has 10 questions about treatments physical and emotional effects.
Module has two subdimensions called "Environment" and "Tolerability" and each subdimensions and total scale score can between 0-100 points.
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from obtaining ethical permission to reaching sampling (approximately 6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Centred Care
Time Frame: from obtaining ethical permission to reaching sampling (approximately 6 months)
|
Patient Centred Care Questionnaire Form for Infertile Women was used to evaluate patient centred care approach.
This questionnaire was prepared by researchers according to literature (IOM, 2001; Picker, 2001).There is no scoring for this tool.
|
from obtaining ethical permission to reaching sampling (approximately 6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Actual)
September 20, 2020
Study Completion (Actual)
November 30, 2020
Study Registration Dates
First Submitted
June 19, 2021
First Submitted That Met QC Criteria
October 2, 2021
First Posted (Actual)
October 15, 2021
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 21, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Istanbul UC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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