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

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

      • İstanbul, Turkey, 34510
        • Elif Balkan

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.
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

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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