Patient Centred CareNCT05078996
Treatment-related Quality of Life and Patient-Centred Care With Infertility
An observational study of Patient Centred Care and Compliance, Treatment, run by Elif Balkan at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Centred Care, Compliance, Treatment, Infertility, Female
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 30 Nov 2020
- 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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who diagnosed with infertility
Who may be able to join
- Diagnosed with infertility
- Has no commnunication problems
Who cannot join
- Communication problems (e.g language)
- Diagnosed by diseases with reproductive problems but not infertility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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".
- Keywords
- patient centred care, FertiQol, infertility, quality of life, nursing
- Medical subject headings
- Patient Compliance, Infertility, Female, Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related quality of life
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.
Measured: from obtaining ethical permission to reaching sampling (approximately 6 months)
Secondary outcomes (1)
Patient Centred Care
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.
Measured: from obtaining ethical permission to reaching sampling (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Jun 2020
- Primary completion20 Sep 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Centred CareStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elif Balkan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elif Balkan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078996
- Sponsor's protocol ID
- Istanbul UC
- Status last verified
- Sep 2023
- First submitted
- 19 Jun 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centred Care and Treatment-related Quality of Life With Infertility
- ClinicalTrials.gov ID
- NCT05078996
- Acronym / sponsor ID
- Istanbul UC
- Keywords
- patient centred care, FertiQol, infertility, quality of life, nursing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Elif BalkanUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 15 Oct 2021 (actual)
- 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 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who diagnosed with infertility
Key inclusion criteria (2 listed)
- Diagnosed with infertility
- Has no commnunication problems
Key exclusion criteria (2 listed)
- Communication problems (e.g language)
- Diagnosed by diseases with reproductive problems but not infertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Patient Centred Care
Time frame: from obtaining ethical permission to reaching sampling (approximately 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Patient Centred Care and Compliance, Treatment, run by Elif Balkan at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 25 Sep 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related quality of life (time frame: from obtaining ethical permission to reaching sampling (approximately 6 months)). 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 25 Sep 2023.