Health, SubjectiveHeRFAPIWNCT04970420
Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks).
A study testing Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks). in people with Health, Subjective and Family Planning, run by Karadeniz Technical University.
Trial summary
Purpose: The aims of the research are to determine the effects of individual trainings on family planning given to migrant women (Ahıska Turks), repetitive trainings via mobile applications, telephone counseling initiatives on women's health responsibility levels, family planning knowledge and attitudes. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective, Family Planning, Women
- What is being tested?
- Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to May 2022
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- To be registered at the family health center
- Being literate
- Ability to communicate verbally
- Volunteering to participate in the research
- Owning a smartphone or a phone belonging to any member of the family that can also be used by the participant
- Having internet access at home or at work
Show all 9Show fewer
- Internet use
- Able to speak and write Turkish
- Being a migrant woman in the age group of 15-49
Who cannot join
- Having a physical or mental health problem
- Menopausal, tubal ligation or spouse vasectomy
- Inability to reach by phone/visit
- Relocation of women to another place
- Illness and death of the sampled woman
- To have received training on effective family planning
Trial locations and contacts
No sites are listed yet.
Birsel Canan DEMİRBAĞ, PhD contact
About this study
Official title: Evaluation of Nursing Interventions Given to Immigrant Women (Ahıska Turks) Towards Health Responsibility, Family Planning Knowledge and Attitude
Purpose: The aims of the research are to determine the effects of individual trainings on family planning given to migrant women (Ahıska Turks), repetitive trainings via mobile applications, telephone counseling initiatives on women's health responsibility levels, family planning knowledge and attitudes.
Design: This pretest-posttest is an interventional quasi-experimental research. Method: Standard protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement 2013 checklist is used in this study. The CONSORT (Consolidated Standards of Reporting Trials) flowchart is used in this protocol. This study will be carried out with immigrant (Ahıska Turks) women between the ages of 15-49 who are registered in Üzümlü Family Health Center in Üzümlü district of Erzincan province. In this study, individual training on family planning and health responsibility, repetitive training via mobile application and telephone counseling initiatives will be made. The same applications will be applied to the control group after the study data is collected.
Read more
Hypotheses: H1: Mobile applications for family planning, telephone counseling and individual training have an impact on the family planning attitudes of immigrant women.
H1: Mobile applications for family planning, telephone counseling and individual trainings have an impact on the family planning knowledge level of immigrant women.
H1: Mobile applications, telephone counseling and individual trainings for health responsibility have an impact on the level of health responsibility of migrant women.
- Conditions
- Health, Subjective, Family Planning, Women, Nurse
- Being tested
- Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks)., Control group
- Keywords
- Family planning, Knowledge, Emigration, Attitude, Immigration
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks).Other
In this study, individual training, training via mobile application and telephone counseling will be given to the experimental group. During the meetings, attention will be paid to the pandemic rules.
Control groupOther
Individual training, mobile application and telephone counseling will be given to the control group after the study data is collected.
| Study group | Role | What they receive |
|---|---|---|
| HeRFAPIW | Experimental | Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks). Receives: Other: Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks). |
| Control group | Active comparator | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Lifestyle Behaviors Scale II-Health Responsibility Sub-Dimension
The lowest score in the Health Responsibility Sub-Dimension was determined as 9 and the highest as 36 points. As the score obtained from the Sub-Dimension of the Scale increases, the health responsibility increases. Health Responsibility sub-dimension Cronbach Alpha coefficient is 0.77.
Measured: Change in health responsibility at baseline and after 12 weeks.
Family Planning Attitude Scale
A minimum of 34 and a maximum of 170 points can be obtained from the scale. The scale has 3 sub-dimensions: "Attitude of the Society towards Family Planning", "Attitude towards Family Planning Methods" and "Attitude towards Birth". Evaluation of the scale is done as individuals with higher scores have more positive family planning attitudes. The internal consistency and homogeneity coefficients determined by the alpha correlations of the scale were found to be 0.90 in total.
Measured: Change in health responsibility at baseline and after 12 weeks.
Family Planning Information Form
This form, which was developed by the researcher based on the literature, consists of questions that include mobile application and telephone counseling comprehensive initiatives. A minimum of 0 and a maximum of 75 points are taken from the form. Evaluation of the form is made as individuals with high scores have knowledge about family planning.
Measured: Change in health responsibility at baseline and after 12 weeks.
Secondary outcomes (1)
Family Planning Program Evaluation Form
In the form developed by the researchers, it is related to the benefits of the family planning training program for the participants, their satisfaction with the training program, the perception of the knowledge level of women on family planning after the training, suggestions for the development of the training program and the family planning method used after the training. There are 7 questions.
Measured: Level of satisfaction with the programs implemented after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Demirtürk Selçuk, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970420
- Sponsor's protocol ID
- 0061
- Acronym
- HeRFAPIW
- Status last verified
- Jul 2021
- First submitted
- 30 Jun 2021
- Last updated
- 21 Jul 2021
- Results posted
- 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 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nursing Interventions Given to Immigrant Women (Ahıska Turks) Towards Health Responsibility, Family Planning Knowledge and Attitude
- ClinicalTrials.gov ID
- NCT04970420
- Acronym / sponsor ID
- HeRFAPIW / 0061
- Conditions
- Health, Subjective, Family Planning, Women, Nurse
- Keywords
- Family planning, Knowledge, Emigration, Attitude, Immigration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 21 Jul 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.
Purpose: The aims of the research are to determine the effects of individual trainings on family planning given to migrant women (Ahıska Turks), repetitive trainings via mobile applications, telephone counseling initiatives on women's health responsibility levels, family planning knowledge and attitudes.
Design: This pretest-posttest is an interventional quasi-experimental research. Method: Standard protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement 2013 checklist is used in this study. The CONSORT (Consolidated Standards of Reporting Trials) flowchart is used in this protocol. This study will be carried out with immigrant (Ahıska Turks) women between the ages of 15-49 who are registered in Üzümlü Family Health Center in Üzümlü district of Erzincan province. In this study, individual training on family planning and health responsibility, repetitive training via mobile application and telephone counseling initiatives will be made. The same applications will be applied to the control group after the study data is collected.
Hypotheses: H1: Mobile applications for family planning, telephone counseling and individual training have an impact on the family planning attitudes of immigrant women.
H1: Mobile applications for family planning, telephone counseling and individual trainings have an impact on the family planning knowledge level of immigrant women.
H1: Mobile applications, telephone counseling and individual trainings for health responsibility have an impact on the level of health responsibility of migrant women.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeRFAPIW | Experimental | Other: Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks).Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks). |
| Control group | Active comparator | Other: Control group |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- To be registered at the family health center
- Being literate
- Ability to communicate verbally
- Volunteering to participate in the research
- Owning a smartphone or a phone belonging to any member of the family that can also be used by the participant
Key exclusion criteria (6 listed)
- Having a physical or mental health problem
- Menopausal, tubal ligation or spouse vasectomy
- Inability to reach by phone/visit
- Relocation of women to another place
- Illness and death of the sampled woman
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 |
|---|---|---|
| Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks).In this study, individual training, training via mobile application and telephone counseling will be given to the experimental group. During the meetings, attention will be paid to the pandemic rules. | Other | HeRFAPIW |
| Control groupIndividual training, mobile application and telephone counseling will be given to the control group after the study data is collected. | Other | Control group |
Primary outcome
Healthy Lifestyle Behaviors Scale II-Health Responsibility Sub-Dimension
Time frame: Change in health responsibility at baseline and after 12 weeks.
The lowest score in the Health Responsibility Sub-Dimension was determined as 9 and the highest as 36 points. As the score obtained from the Sub-Dimension of the Scale increases, the health responsibility increases. Health Responsibility sub-dimension Cronbach Alpha coefficient is 0.77.
Family Planning Attitude Scale
Time frame: Change in health responsibility at baseline and after 12 weeks.
A minimum of 34 and a maximum of 170 points can be obtained from the scale. The scale has 3 sub-dimensions: "Attitude of the Society towards Family Planning", "Attitude towards Family Planning Methods" and "Attitude towards Birth". Evaluation of the scale is done as individuals with higher scores have more positive family planning attitudes. The internal consistency and homogeneity coefficients determined by the alpha correlations of the scale were found to be 0.90 in total.
Family Planning Information Form
Time frame: Change in health responsibility at baseline and after 12 weeks.
This form, which was developed by the researcher based on the literature, consists of questions that include mobile application and telephone counseling comprehensive initiatives. A minimum of 0 and a maximum of 75 points are taken from the form. Evaluation of the form is made as individuals with high scores have knowledge about family planning.
1 secondary outcome
Family Planning Program Evaluation Form
Time frame: Level of satisfaction with the programs implemented after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- 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.
Birsel Canan DEMİRBAĞ, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks). in people with Health, Subjective and Family Planning, run by Karadeniz Technical University.
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 9 inclusion and 6 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 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Ezgi DEMİRTÜRK SELÇUK, MSc (05448502161, demirturkezgi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Lifestyle Behaviors Scale II-Health Responsibility Sub-Dimension (time frame: Change in health responsibility at baseline and after 12 weeks.). The study lists 3 primary outcomes in all. 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 21 Jul 2021.