Infertility, FemaleNCT06181890
The Effect of Motivational Interviews
An observational study of Infertility, Female, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to determine the effect of motivational interviews applied to infertile women on their ability to cope with infertility, self-efficacy and stress. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Motivational Interview
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2023to 25 Jun 2024
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The population of the research will be infertile women who come to Kahramanmaraş Necip Fazıl City Hospital Gynecology and Pediatrics Annex Building for infertility treatment.
Who may be able to join
- Ages 18 and over and have no problems communicating Those who have not previously or currently been diagnosed with a psychiatric disease Infertile women who volunteer will be included in the sample of the research
Who cannot join
- Pregnancy during the study, Having previously or currently participated in a motivational interviewing program, Those who want to leave the research, Not completing motivational interviewing sessions, Infertile women with any deficiencies or errors in any of the forms from which the data are obtained will be excluded from the sample.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Motivational Interviews Applied to Infertile Women on Infertility Affect, Self-Efficacy and Coping With Stress
The aim of the study was to determine the effect of motivational interviews applied to infertile women on their ability to cope with infertility, self-efficacy and stress.
Read the detailed description
There is no study in the literature on the effectiveness of motivational interviewing on being affected by infertility, self-efficacy and coping with stress. It is important for healthcare personnel to be easy to apply and short-term, to be aware of the effectiveness of the motivational interviewing technique, and to use this technique in communicating with the patient and changing behavior. Based on these, it was deemed necessary to examine the effect of motivational interviews for infertile women.
- Conditions
- Infertility, Female
- Being tested
- Motivational Interview
- Keywords
- Infertility, Motivational Interview, Stress
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewOther
The data of the research will be collected between October 2023 and June 2024. Each meeting will last approximately 15-30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| control group | Infertile women who will be included in the control group will be interviewed twice in total. Pretest data will be obtained by applying the "Personal Information Form", "Infertility Impact Scale", "Infertility Self-Efficacy Scale - Short Form" and "Coping with Infertility Stress Scale" in the first interview. Four weeks after obtaining the pre-test data, post-test data will be obtained by applying the "Infertility Impact Scale", "Infertility Self-Efficacy Scale - Short Form" and "Coping with Infertility Stress Scale". | |
| intervention group | Before starting motivational interviews with infertile women in the intervention group, pre-test data will be obtained by applying the "Personal Information Form", "Infertility Impact Scale", "Infertility Self-Efficacy Scale - Short Form" and "Coping with Infertility Stress Scale". A total of 4 sessions of motivational interviews will be held for infertile women, 1 session per week for four weeks. At the end of four weeks, post-test data will be obtained by applying the "Infertility Impact Scale", "Infertility Self-Efficacy Scale - Short Form" and "Coping with Infertility Stress Scale". Receives: Other: Motivational Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
motivational interview
A total of 4 sessions of motivational interviews will be held for infertile women, 1 session per week for four weeks.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start25 Oct 2023
- Primary completion25 Jun 2024 (estimated)
- Study completion25 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Sever, Kahramanmaras Sutcu Imam University
- Investigators
- Esra Karataş Okyay, Principal investigator, Kahramanmaras Sutcu Imam UniversityEda Sever, Study director, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181890
- Sponsor's protocol ID
- KSIU-SBF-ES-01
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 26 Dec 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviews Applied to Infertile Women on Infertility Affect, Self-Efficacy and Coping With Stress
- ClinicalTrials.gov ID
- NCT06181890
- Acronym / sponsor ID
- KSIU-SBF-ES-01
- Conditions
- Infertility, Female
- Keywords
- Infertility, Motivational Interview, Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 25 Jun 2024 (estimated)
- Study completion
- 25 Jun 2024 (estimated)
- First posted
- 26 Dec 2023 (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.
The aim of the study was to determine the effect of motivational interviews applied to infertile women on their ability to cope with infertility, self-efficacy and stress.
Detailed description
There is no study in the literature on the effectiveness of motivational interviewing on being affected by infertility, self-efficacy and coping with stress. It is important for healthcare personnel to be easy to apply and short-term, to be aware of the effectiveness of the motivational interviewing technique, and to use this technique in communicating with the patient and changing behavior. Based on these, it was deemed necessary to examine the effect of motivational interviews for infertile women.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –Infertile women who will be included in the control group will be interviewed twice in total. Pretest data will be obtained by applying the "Personal Information Form", "Infertility Impact Scale", "Infertility Self-Efficacy Scale - Short Form" and "Coping with Infertility Stress Scale" in the first interview. Four weeks after obtaining the pre-test data, post-test data will be obtained by applying the "Infertility Impact Scale", "Infertility Self-Efficacy Scale - Short Form" and "Coping with Infertility Stress Scale". |
| intervention group | – | Other: Motivational InterviewBefore starting motivational interviews with infertile women in the intervention group, pre-test data will be obtained by applying the "Personal Information Form", "Infertility Impact Scale", "Infertility Self-Efficacy Scale - Short Form" and "Coping with Infertility Stress Scale". A total of 4 sessions of motivational interviews will be held for infertile women, 1 session per week for four weeks. At the end of four weeks, post-test data will be obtained by applying the "Infertility Impact Scale", "Infertility Self-Efficacy Scale - Short Form" and "Coping with Infertility Stress Scale". |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population of the research will be infertile women who come to Kahramanmaraş Necip Fazıl City Hospital Gynecology and Pediatrics Annex Building for infertility treatment.
Key inclusion criteria (1 listed)
- Ages 18 and over and have no problems communicating Those who have not previously or currently been diagnosed with a psychiatric disease Infertile women who volunteer will be included in the sample of the research
Key exclusion criteria (1 listed)
- Pregnancy during the study, Having previously or currently participated in a motivational interviewing program, Those who want to leave the research, Not completing motivational interviewing sessions, Infertile women with any deficiencies or errors in any of the forms from which the data are obtained will be excluded from the sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewThe data of the research will be collected between October 2023 and June 2024. Each meeting will last approximately 15-30 minutes. | Other | intervention group |
Primary outcome
motivational interview
Time frame: 1 month
A total of 4 sessions of motivational interviews will be held for infertile women, 1 session per week for four weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 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.
Esra Karataş Okyay principal investigator
Kahramanmaras Sutcu Imam University
Eda Sever study director
Kahramanmaras Sutcu Imam University
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 Infertility, Female, run by Kahramanmaras Sutcu Imam University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Dec 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?
Results are not available in the source record.
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?
motivational interview (time frame: 1 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 26 Dec 2023.