Female Sexual Dysfunction (FSD)NCT06880900
Developing a Clinical Practice Guideline With The Delphi Technique for Evaluation and Counseling of Women's Sexual Health
An observational study of Female Sexual Dysfunction (FSD) and Sexuality and Reproductive Issues, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Type of Research The research will be conducted prospectively and methodologically. The Delphi Technique, one of the qualitative research methods, will be used. Location and Time of Research Data collection will take place between April 12, 2023, and June 12, 2024, at universities, non-governmental organizations… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Female Sexual Dysfunction (FSD), Sexuality and Reproductive Issues
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 3 Jun 2025
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 90
Who may be able to join
- Women with sexual dysfunction
- Women without any sexual dysfunction
- Health professionals who specialize in women's sexual health (physician, nurse/midwife, psychologist, academic)
- Women and health professionals who agree to participate in the study
Who cannot join
- Men with sexual dysfunction
- Men without any sexual dysfunction
- Healthcare professionals (physician, nurse/midwife, psychologist, academic) who do not have expertise in women's sexual health
- Women who do not agree to participate in the study and health professionals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Üniversitesi-Cerrahpaşa
Istanbul, 34000
İsmail Çepni, professor, +90 (212) 414 34 34, ctf@iuc.edu.tr
About this study
Type of Research The research will be conducted prospectively and methodologically. The Delphi Technique, one of the qualitative research methods, will be used.
Location and Time of Research Data collection will take place between April 12, 2023, and June 12, 2024, at universities, non-governmental organizations (NGOs) operating in the field of sexual health, and hospitals located in Istanbul.
Read more
Population and Sample of the Research A purposive sampling method will be used to select the participant group. Experts in sexual health working in universities, counseling centers, private and public hospitals, including nurses, physicians, psychologists, and academicians, as well as women with and without sexual dysfunction, will be included in the expert opinion team.
The ideal group size for the Delphi technique is reported to be 10-20 experts, with a minimum of 7, although this number may vary depending on the subject (Şahin, 2001). In this study, the target is to include 15 participants from each group, representing different fields, for a total of 90 participants.
Data Collection Before data collection, approval will be obtained from the Istanbul University-Cerrahpaşa Non-Interventional Clinical Research Ethics Committee and institutional permission from the Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty Hospital, Gynecology and Obstetrics Polyclinic.
The research will consist of two main stages. In the first stage, a clinical practice guide for evaluating and counseling women's sexual health will be created using the Delphi technique. In the second stage, the guide will be made available, and feedback will be collected from practitioners and women regarding the guide.
The Delphi technique, which will be used in the first stage, is a valid and reliable data collection method that systematically gathers expert opinions. It also allows for consensus to be reached in cases where there are differences of opinion. One of the applications of the Delphi technique is the development of standards.
Clinical Practice Guidelines are developed worldwide using three different Delphi methods: de novo, translated guides, and adaptation. In this study, the de novo Delphi method is planned to be used. The de novo guideline development method is employed when no previous guideline exists for the field of study or when existing guidelines have lost their validity. This method includes steps such as selecting the topic, forming working groups, preparing a draft guideline based on evidence and recommendations, presenting the draft to expert opinion, publishing the final guideline, delivering it to the target audience, and re-evaluating and updating it.
In this study, instead of the classical Delphi technique, the E-Delphi technique will be used with the help of electronic communication tools. The research, which will be completed after three Delphi sessions, will involve contacting participants via email and telephone.
In the first stage, experts will be identified, and face-to-face meetings will be conducted with participants for introductions. The participants' views on evaluating women's sexual health and sexual health care standards will be collected over three separate sessions using the Delphi method.
In the second stage, the guide created will be provided to healthcare workers, and it will be expected that the sexual health of women with and without sexual dysfunction will be evaluated and counseled according to this guide. Feedback from practitioners and women regarding the guide will be collected during this stage. This pilot study will be applied to 10 healthcare workers and 10 women with and without sexual dysfunction. Participants' views on the guide will be evaluated using the "Guide Satisfaction Survey (Appendix-4)."
Data Collection Tool Separate data collection tools will be used for each of the three Delphi sessions.
In the first Delphi session, the "I. Delphi Survey (Appendix-2)" will include open-ended questions addressing the research problem and demographic information. Participants will also receive the "Invitation Text (Appendix-1)" and "Informed Consent Form (Appendix-3)" containing general information about the study process and the Delphi technique.
In the second Delphi session, suggestions from the I. Delphi Survey and a literature review conducted before the sessions will be used to create standard items. These items will be compiled into a Likert-type survey, called the "II. Delphi Survey," designed to gather participants' opinions on the created items and determine their level of agreement. Participants will also be asked to add any new items, comments, or suggestions they may have.
In the third Delphi session, standard items resulting from the evaluation of data from the second Delphi session will be compiled into a Likert-type su
- Keywords
- female sexual dysfunction, Clinical Practice Guideline, Delphi Technique, Women's Sexual Health
- Medical subject headings
- Sexuality
What is being measured
The primary outcome is the main question the study is designed to answer.
I. Delphi Survey
In the first Delphi session, the "I. Delphi Survey (Appendix-2)" will include open-ended questions addressing the research problem and demographic information. Qualitative analyses will be conducted on the answers given to open-ended questions. Therefore, there is no cut-off value or score information in the survey study.
Measured: 2 month
Secondary outcomes (1)
pilot study
n the second stage, the guide created will be provided to healthcare workers, and it will be expected that the sexual health of women with and without sexual dysfunction will be evaluated and counseled according to this guide. Feedback from practitioners and women regarding the guide will be collected during this stage. This pilot study will be applied to 10 healthcare workers and 10 women with and without sexual dysfunction. Participants' views on the guide will be evaluated using the "Guide Satisfaction Survey (Appendix-4)."
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start10 Mar 2025 (estimated)
- Primary completion3 Apr 2025 (estimated)
- Study completion3 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual Dysfunction (FSD)Studies 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
- 90 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Handan Eriten tilaver, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880900
- Sponsor's protocol ID
- HEritentilaver-IUC-PhD
- Status last verified
- Mar 2025
- First submitted
- 29 Dec 2024
- Last updated
- 18 Mar 2025
- 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 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Clinical Practice Guideline With The Delphi Technique for Evaluation and Counseling of Women's Sexual Health
- ClinicalTrials.gov ID
- NCT06880900
- Acronym / sponsor ID
- HEritentilaver-IUC-PhD
- Keywords
- female sexual dysfunction, Clinical Practice Guideline, Delphi Technique, Women's Sexual Health
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 3 Apr 2025 (estimated)
- Study completion
- 3 Jun 2025 (estimated)
- First posted
- 18 Mar 2025 (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.
Type of Research The research will be conducted prospectively and methodologically. The Delphi Technique, one of the qualitative research methods, will be used.
Location and Time of Research Data collection will take place between April 12, 2023, and June 12, 2024, at universities, non-governmental organizations (NGOs) operating in the field of sexual health, and hospitals located in Istanbul.
Population and Sample of the Research A purposive sampling method will be used to select the participant group. Experts in sexual health working in universities, counseling centers, private and public hospitals, including nurses, physicians, psychologists, and academicians, as well as women with and without sexual dysfunction, will be included in the expert opinion team.
The ideal group size for the Delphi technique is reported to be 10-20 experts, with a minimum of 7, although this number may vary depending on the subject (Şahin, 2001). In this study, the target is to include 15 participants from each group, representing different fields, for a total of 90 participants.
Data Collection Before data collection, approval will be obtained from the Istanbul University-Cerrahpaşa Non-Interventional Clinical Research Ethics Committee and institutional permission from the Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty Hospital, Gynecology and Obstetrics Polyclinic.
The research will consist of two main stages. In the first stage, a clinical practice guide for evaluating and counseling women's sexual health will be created using the Delphi technique. In the second stage, the guide will be made available, and feedback will be collected from practitioners and women regarding the guide.
The Delphi technique, which will be used in the first stage, is a valid and reliable data collection method that systematically gathers expert opinions. It also allows for consensus to be reached in cases where there are differences of opinion. One of the applications of the Delphi technique is the development of standards.
Clinical Practice Guidelines are developed worldwide using three different Delphi methods: de novo, translated guides, and adaptation. In this study, the de novo Delphi method is planned to be used. The de novo guideline development method is employed when no previous guideline exists for the field of study or when existing guidelines have lost their validity. This method includes steps such as selecting the topic, forming working groups, preparing a draft guideline based on evidence and recommendations, presenting the draft to expert opinion, publishing the final guideline, delivering it to the target audience, and re-evaluating and updating it.
In this study, instead of the classical Delphi technique, the E-Delphi technique will be used with the help of electronic communication tools. The research, which will be completed after three Delphi sessions, will involve contacting participants via email and telephone.
In the first stage, experts will be identified, and face-to-face meetings will be conducted with participants for introductions. The participants' views on evaluating women's sexual health and sexual health care standards will be collected over three separate sessions using the Delphi method.
In the second stage, the guide created will be provided to healthcare workers, and it will be expected that the sexual health of women with and without sexual dysfunction will be evaluated and counseled according to this guide. Feedback from practitioners and women regarding the guide will be collected during this stage. This pilot study will be applied to 10 healthcare workers and 10 women with and without sexual dysfunction. Participants' views on the guide will be evaluated using the "Guide Satisfaction Survey (Appendix-4)."
Data Collection Tool Separate data collection tools will be used for each of the three Delphi sessions.
In the first Delphi session, the "I. Delphi Survey (Appendix-2)" will include open-ended questions addressing the research problem and demographic information. Participants will also receive the "Invitation Text (Appendix-1)" and "Informed Consent Form (Appendix-3)" containing general information about the study process and the Delphi technique.
In the second Delphi session, suggestions from the I. Delphi Survey and a literature review conducted before the sessions will be used to create standard items. These items will be compiled into a Likert-type survey, called the "II. Delphi Survey," designed to gather participants' opinions on the created items and determine their level of agreement. Participants will also be asked to add any new items, comments, or suggestions they may have.
In the third Delphi session, standard items resulting from the evaluation of data from the second Delphi session will be compiled into a Likert-type su
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 90
Key inclusion criteria (4 listed)
- Women with sexual dysfunction
- Women without any sexual dysfunction
- Health professionals who specialize in women's sexual health (physician, nurse/midwife, psychologist, academic)
- Women and health professionals who agree to participate in the study
Key exclusion criteria (4 listed)
- Men with sexual dysfunction
- Men without any sexual dysfunction
- Healthcare professionals (physician, nurse/midwife, psychologist, academic) who do not have expertise in women's sexual health
- Women who do not agree to participate in the study and health professionals
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
I. Delphi Survey
Time frame: 2 month
In the first Delphi session, the "I. Delphi Survey (Appendix-2)" will include open-ended questions addressing the research problem and demographic information. Qualitative analyses will be conducted on the answers given to open-ended questions. Therefore, there is no cut-off value or score information in the survey study.
1 secondary outcome
pilot study
Time frame: 5 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- 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.
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 Female Sexual Dysfunction (FSD) and Sexuality and Reproductive Issues, run by Istanbul University - Cerrahpasa 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact handan eriten tilaver, 1 (905454018572, handaneritentilaver@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I. Delphi Survey (time frame: 2 month). 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 18 Mar 2025.