Health EducationNCT04741867
The Effect of Education Based on Roy Adaptation Model for Infertile Individuals on Adaptation and Coping With Stress
A study testing Education in people with Health Education, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
Trial summary
Psychosocial counseling applied together with infertility treatment programs makes infertile women more resistant to stress, increases the effectiveness of infertility treatments and encourages infertile patients to continue treatment by improving their mental health. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Health Education
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2021to Oct 2021
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-45age difference
- Primary infertility
Who cannot join
- Secondery infertility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hasan Kalyoncu University Health Sciences Institute
Psychosocial counseling applied together with infertility treatment programs makes infertile women more resistant to stress, increases the effectiveness of infertility treatments and encourages infertile patients to continue treatment by improving their mental health.
It appears that learning adaptation strategies in infertile couples is concurrent with health promotion. In addition to medical treatments, it is aimed to add training to be given in accordance with the Roy Adaptation model, to adapt to the process and infertility, and to control stress in infertile individuals in the management of the process.
The study was planned to examine the effect of education based on the roy adaptation model for infertile individuals on adaptation and coping with stress.
- Conditions
- Health Education
- Being tested
- Education
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Patients will be educated to determine their level of coping with stress and their adaptation.
| Study group | Role | What they receive |
|---|---|---|
| receiving health education | Experimental | Not described Receives: Other: Education |
| Level of compliance | Experimental | Not described Receives: Other: Education |
| Coping with stress | Experimental | Not described Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Training effectiveness
The education given will increase adaptation to infertility and coping with existing stress.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health EducationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Duygu Özbaş, Gaziantep Islam Science and Technology University
- Investigators
- Ayşe Duygu Özbaş, Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741867
- Sponsor's protocol ID
- Hasan Kalyoncu Unıversity
- Status last verified
- Feb 2021
- First submitted
- 26 Jan 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hasan Kalyoncu University Health Sciences Institute
- ClinicalTrials.gov ID
- NCT04741867
- Acronym / sponsor ID
- Hasan Kalyoncu Unıversity
- Conditions
- Health Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 5 Feb 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.
Psychosocial counseling applied together with infertility treatment programs makes infertile women more resistant to stress, increases the effectiveness of infertility treatments and encourages infertile patients to continue treatment by improving their mental health.
It appears that learning adaptation strategies in infertile couples is concurrent with health promotion. In addition to medical treatments, it is aimed to add training to be given in accordance with the Roy Adaptation model, to adapt to the process and infertility, and to control stress in infertile individuals in the management of the process.
The study was planned to examine the effect of education based on the roy adaptation model for infertile individuals on adaptation and coping with stress.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| receiving health education | Experimental | Other: Education |
| Level of compliance | Experimental | Other: Education |
| Coping with stress | Experimental | Other: Education |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-45age difference
- Primary infertility
Key exclusion criteria (1 listed)
- Secondery infertility
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 |
|---|---|---|
| EducationPatients will be educated to determine their level of coping with stress and their adaptation. | Other | Coping with stress, Level of compliance, receiving health education |
Primary outcome
Training effectiveness
Time frame: 3 months
The education given will increase adaptation to infertility and coping with existing stress.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Health Education
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Enrolling by invitationPhase 2
Deployment and Evaluation of Humanoid Robotics in Coalition-Aligned Clinical Care Settings
Mobility Impairment, Clinical Workflow Optimization
Active, not recruiting
What Works to Prevent Violence Against Women and Girls in Madagascar
Comprehensive Sexual Education
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.
Ayşe Duygu Özbaş principal investigator
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Health Education, run by Gaziantep Islam Science and Technology 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 2 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 5 Feb 2021. 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?
Contact Ayşe Duygu Özbaş (905337625707, duyguyildirim75@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training effectiveness (time frame: 3 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 5 Feb 2021.