Genital Infection FemaleNCT04780633
PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors
A study testing Precede-Proceed based Training Program on Genital Hygiene Behaviors in people with Genital Infection Female, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to investigate the effect of a training program based on the PRECEDE-PROCEED Model on improving genital hygiene behaviors.It was carried out using experimental research design with pre-test and post-test, randomized and a control group. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Genital Infection Female
- What is being tested?
- Precede-Proceed based Training Program on Genital Hygiene Behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2017to 15 Oct 2017
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18-49,
- married,
- At least primary school graduate,
- No mental and communication problems,
- No chronic disease,
- Non-pregnant.
Who cannot join
- Women who have entered menopause,
- Women who had received any training on genital hygiene before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors: A Randomized Controlled Trial
The study was conducted to investigate the effect of a training program based on the PRECEDE-PROCEED Model on improving genital hygiene behaviors.It was carried out using experimental research design with pre-test and post-test, randomized and a control group. The study was conducted at Erzurum Saltuklu Family Health Center between June 2017 and January 2018. Of the women with genital infections, 120 women were included in the study, of which 60 were in the experimental group and 60 were in the control group. The data were collected by "Personal Information Form," "Genital Hygiene Knowledge, Attitude and Beliefs, Questionnaire" and "Genital Hygiene Behavior Inventory". In study, genital hygiene training intervention prepared according to the Precede-Proceed model was applied to the women in the experimental group. The women in the experimental group were measured at three different times: pre-test before training, post-test through training completition, and follow-up test after 4 weeks. The women in the control group did not receive any training intervention, the pre-test at the first encounter in the family health center and the post-test 5 weeks later.
- Conditions
- Genital Infection Female
- Being tested
- Precede-Proceed based Training Program on Genital Hygiene Behaviors
- Keywords
- Genital hygiene behavior, Women's health, Precede-Proceed model, Health education, Nursing
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precede-Proceed based Training Program on Genital Hygiene BehaviorsBehavioural
A Training Program for Genital Hygiene Behaviors prepared in line with the Precede-Proceed model was presented to the women in the experimental group. The trainings started one week after the pre-test data were collected and were conducted in a total of 5 sessions, each lasting an average of 40 minutes, once a week. At the end of the five-week training, a post-test was applied. In order to determine the behavior changes of the women in the experimental group, a follow-up test was applied 4 weeks after the training ended. At the end of the training, women were given a training booklet prepared by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Precede-Proceed based Training Program | Experimental | The experimental group is the group in which five training sessions interventions are applied. Receives: Behavioral: Precede-Proceed based Training Program on Genital Hygiene Behaviors |
| Control group | No intervention | The control group is the group in which have no educational intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
H1 hypothesis: PRECEDE-PROCEED training-based program affects on improving genital hygiene behavior.
Linear regression analysis was performed to determine the factors that are independently effective in determining the Genital Hygiene Behavior Inventory (GHBI) score differences between the pre-test and post-test measurements of the women in the experimental group.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start15 Jun 2017
- Primary completion30 Sep 2017
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Infection FemaleStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manolya Parlas, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780633
- Sponsor's protocol ID
- Approval No: 2017-3/20
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 3 Mar 2021
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04780633
- Acronym / sponsor ID
- Approval No: 2017-3/20
- Conditions
- Genital Infection Female
- Keywords
- Genital hygiene behavior, Women's health, Precede-Proceed model, Health education, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 3 Mar 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.
The study was conducted to investigate the effect of a training program based on the PRECEDE-PROCEED Model on improving genital hygiene behaviors.It was carried out using experimental research design with pre-test and post-test, randomized and a control group. The study was conducted at Erzurum Saltuklu Family Health Center between June 2017 and January 2018. Of the women with genital infections, 120 women were included in the study, of which 60 were in the experimental group and 60 were in the control group. The data were collected by "Personal Information Form," "Genital Hygiene Knowledge, Attitude and Beliefs, Questionnaire" and "Genital Hygiene Behavior Inventory". In study, genital hygiene training intervention prepared according to the Precede-Proceed model was applied to the women in the experimental group. The women in the experimental group were measured at three different times: pre-test before training, post-test through training completition, and follow-up test after 4 weeks. The women in the control group did not receive any training intervention, the pre-test at the first encounter in the family health center and the post-test 5 weeks later.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precede-Proceed based Training Program | Experimental | Behavioral: Precede-Proceed based Training Program on Genital Hygiene BehaviorsThe experimental group is the group in which five training sessions interventions are applied. |
| Control group | No intervention | –The control group is the group in which have no educational intervention. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between the ages of 18-49,
- married,
- At least primary school graduate,
- No mental and communication problems,
- No chronic disease,
Key exclusion criteria (2 listed)
- Women who have entered menopause,
- Women who had received any training on genital hygiene before
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 |
|---|---|---|
| Precede-Proceed based Training Program on Genital Hygiene BehaviorsA Training Program for Genital Hygiene Behaviors prepared in line with the Precede-Proceed model was presented to the women in the experimental group. The trainings started one week after the pre-test data were collected and were conducted in a total of 5 sessions, each lasting an average of 40 minutes, once a week. At the end of the five-week training, a post-test was applied. In order to determine the behavior changes of the women in the experimental group, a follow-up test was applied 4 weeks after the training ended. At the end of the training, women were given a training booklet prepared by the researcher. | Behavioural | Precede-Proceed based Training Program |
Primary outcome
H1 hypothesis: PRECEDE-PROCEED training-based program affects on improving genital hygiene behavior.
Time frame: 5 weeks
Linear regression analysis was performed to determine the factors that are independently effective in determining the Genital Hygiene Behavior Inventory (GHBI) score differences between the pre-test and post-test measurements of the women in the experimental group.
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 3 Mar 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.
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?
A study testing Precede-Proceed based Training Program on Genital Hygiene Behaviors in people with Genital Infection Female, run by Ataturk 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 6 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 3 Mar 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?
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?
H1 hypothesis: PRECEDE-PROCEED training-based program affects on improving genital hygiene behavior. (time frame: 5 weeks). 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 3 Mar 2021.