Genital Hygiene BehaviorsNCT06791252
Genital Hygiene Education and Pregnancy
A study testing genital hygiene education in people with Genital Hygiene Behaviors and Self-Care Ability, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Genital hygiene behaviors are of great importance in preventing urinary tract infections, especially during pregnancy. The study was conducted to determine the effect of genital hygiene education given to pregnant women diagnosed with urinary tract infections on genital hygiene behavior and self-care ability. 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
- Genital Hygiene Behaviors, Self-Care Ability
- What is being tested?
- genital hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2021to 31 Jan 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
- All pregnant women who were literate, - Who had completed their pharmacological treatment (antibiotic treatment) for UTI according to medical records were included in the sample
Who cannot join
- - Those who had previously received training to increase genital hygiene behavior,
- Those who had a risky pregnancy,
- Those who were diagnosed with any health problems related to the pregnant woman and the fetus were not included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Genital Hygiene Education Given to Pregnant Women Diagnosed with Urinary Tract Infection on Genital Hygiene Behavior and Self-Care Agency
Genital hygiene behaviors are of great importance in preventing urinary tract infections, especially during pregnancy. The study was conducted to determine the effect of genital hygiene education given to pregnant women diagnosed with urinary tract infections on genital hygiene behavior and self-care ability. The hypotheses of this study were determined as follows:
H1a: Genital hygiene education affects genital hygiene behavior in pregnant women.
H1b: Genital hygiene education affects self-care ability in pregnant women.
Read the detailed description
Genital hygiene behaviors are of great importance in preventing urinary tract infections, especially during pregnancy. The study was conducted to determine the effect of genital hygiene education given to pregnant women diagnosed with urinary tract infection on genital hygiene behavior and self-care ability. The study was conducted in the gynecology and obstetrics clinics of a hospital in eastern Turkey between September 2021 and February 2022. Personal Information Form, Genital Hygiene Behaviors Scale and Self-Care Ability Scale were used to collect data. In the power analysis, the sample size was calculated as 80 pregnant women in each group (80 experimental, 80 control). Pregnant women in the experimental group received genital hygiene education in 4 sessions, while no intervention was applied to the control group. Descriptive statistical analyses and t-test in dependent-independent groups were used in the analysis of the data.
- Conditions
- Genital Hygiene Behaviors, Self-Care Ability
- Being tested
- genital hygiene education
- Keywords
- Midwife, pregnant, hygiene, self-care, urinary tract infections
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genital hygiene educationBehavioural
The pregnant women in the experimental group were given genital hygiene training individually and in their own homes by the researcher. During the training, the privacy of the client was observed and the researcher and the pregnant women were left alone in the room where the training would be given. Care was taken to ensure that the environment was quiet and calm while the training was given. It was preferred that the pregnant women be in the most comfortable position during the training.
The training was completed by explaining each topic in the training booklet in an average of 20-25 minutes.
Genital hygiene training content:
Session 1 (Day 1): After the introduction phase, information was given about the method to be followed in the study to the pregnant women who agreed to participate in the study. Then, the "Minimum Informed Consent Form" was given to these women, and the pregnant women who approved the form after reading it were included in the study. Pre-test data were collecte
| Study group | Role | What they receive |
|---|---|---|
| Group receiving genital hygiene education | Experimental | Pregnant women in the experimental group were given genital hygiene training in 4 sessions. Receives: Behavioral: genital hygiene education |
| Control Group | No intervention | No intervention was applied to the control group other than the application of data collection tools simultaneously with the pregnant women in the experimental group (pre-test: 1st session/1st day - post-test: 2nd session/30th day). |
What is being measured
The primary outcome is the main question the study is designed to answer.
genital hygiene behavior
Considering that behaviors regarding genital hygiene are established from an early age, it is important to objectively determine risky behaviors in young women who are not yet sexually active in order to take precautions for improving genital hygiene.In this way, many negative outcomes that may occur during the fertile period and are directly related to genital infections, such as infertility, abortion, and the threat of premature birth,can be prevented.On the other hand, it would be useful to use an objective, valid, and reliable measurement tool in determining the relationship between genital hygiene behaviors in women and situations such as the threat of premature birth, premature rupture of membranes, and postpartum infection.The primary outcome of this study is to determine the genital hygiene behaviors of the hygiene education given to women who have previously had urinary tract infections.For this purpose, the General Hygiene Habit and Abnormal Finding Awareness scale was used.
Measured: 30 days
Secondary outcomes (1)
Self-Care Ability
Self-care is the activities initiated and carried out by an individual to protect, maintain and improve their life, health and well-being. According to Orem, self-care needs are divided into three groups: universal, developmental and self-care needs in deviations from health. Universal needs are special care behaviors that occur at different developmental levels of the individual, such as infancy, childhood and pregnancy. Pregnancy is also a developmental condition and is a subject that should be examined separately due to its importance. During pregnancy, a woman may need help if her health deteriorates and she cannot meet her care needs. It is important to use an objective, valid and reliable measurement tool in determining the relationship between the self-care of pregnant women and conditions such as urinary system infections. In this study, self-care power was determined as a secondary outcome and the self-care power scale was used to determine the effect of hygiene training give
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start30 Sep 2021
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Hygiene BehaviorsStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized controlled trial conducted with experimental and control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA GUNEY, PhD, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791252
- Sponsor's protocol ID
- 2021/2261
- Status last verified
- Feb 2022
- First submitted
- 16 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Genital Hygiene Education Given to Pregnant Women Diagnosed with Urinary Tract Infection on Genital Hygiene Behavior and Self-Care Agency
- ClinicalTrials.gov ID
- NCT06791252
- Acronym / sponsor ID
- 2021/2261
- Conditions
- Genital Hygiene Behaviors, Self-Care Ability
- Keywords
- Midwife, pregnant, hygiene, self-care, urinary tract infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 24 Jan 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.
Genital hygiene behaviors are of great importance in preventing urinary tract infections, especially during pregnancy. The study was conducted to determine the effect of genital hygiene education given to pregnant women diagnosed with urinary tract infections on genital hygiene behavior and self-care ability. The hypotheses of this study were determined as follows:
H1a: Genital hygiene education affects genital hygiene behavior in pregnant women.
H1b: Genital hygiene education affects self-care ability in pregnant women.
Detailed description
Genital hygiene behaviors are of great importance in preventing urinary tract infections, especially during pregnancy. The study was conducted to determine the effect of genital hygiene education given to pregnant women diagnosed with urinary tract infection on genital hygiene behavior and self-care ability. The study was conducted in the gynecology and obstetrics clinics of a hospital in eastern Turkey between September 2021 and February 2022. Personal Information Form, Genital Hygiene Behaviors Scale and Self-Care Ability Scale were used to collect data. In the power analysis, the sample size was calculated as 80 pregnant women in each group (80 experimental, 80 control). Pregnant women in the experimental group received genital hygiene education in 4 sessions, while no intervention was applied to the control group. Descriptive statistical analyses and t-test in dependent-independent groups were used in the analysis of the data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial conducted with experimental and control groups
| Arm | Type | Receives |
|---|---|---|
| Group receiving genital hygiene education | Experimental | Behavioral: genital hygiene educationPregnant women in the experimental group were given genital hygiene training in 4 sessions. |
| Control Group | No intervention | –No intervention was applied to the control group other than the application of data collection tools simultaneously with the pregnant women in the experimental group (pre-test: 1st session/1st day - post-test: 2nd session/30th day). |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All pregnant women who were literate, - Who had completed their pharmacological treatment (antibiotic treatment) for UTI according to medical records were included in the sample
Key exclusion criteria (3 listed)
- - Those who had previously received training to increase genital hygiene behavior,
- Those who had a risky pregnancy,
- Those who were diagnosed with any health problems related to the pregnant woman and the fetus were not included in the study
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 |
|---|---|---|
| genital hygiene educationThe pregnant women in the experimental group were given genital hygiene training individually and in their own homes by the researcher. During the training, the privacy of the client was observed and the researcher and the pregnant women were left alone in the room where the training would be given. Care was taken to ensure that the environment was quiet and calm while the training was given. It was preferred that the pregnant women be in the most comfortable position during the training. The training was completed by explaining each topic in the training booklet in an average of 20-25 minutes. Genital hygiene training content: Session 1 (Day 1): After the introduction phase, information was given about the method to be followed in the study to the pregnant women who agreed to participate in the study. Then, the "Minimum Informed Consent Form" was given to these women, and the pregnant women who approved the form after reading it were included in the study. Pre-test data were collecte | Behavioural | Group receiving genital hygiene education |
Primary outcome
genital hygiene behavior
Time frame: 30 days
Considering that behaviors regarding genital hygiene are established from an early age, it is important to objectively determine risky behaviors in young women who are not yet sexually active in order to take precautions for improving genital hygiene.In this way, many negative outcomes that may occur during the fertile period and are directly related to genital infections, such as infertility, abortion, and the threat of premature birth,can be prevented.On the other hand, it would be useful to use an objective, valid, and reliable measurement tool in determining the relationship between genital hygiene behaviors in women and situations such as the threat of premature birth, premature rupture of membranes, and postpartum infection.The primary outcome of this study is to determine the genital hygiene behaviors of the hygiene education given to women who have previously had urinary tract infections.For this purpose, the General Hygiene Habit and Abnormal Finding Awareness scale was used.
1 secondary outcome
Self-Care Ability
Time frame: 30 days
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 29 Jan 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Research results will be shared
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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 genital hygiene education in people with Genital Hygiene Behaviors and Self-Care Ability, run by Inonu 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 3 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 29 Jan 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?
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?
genital hygiene behavior (time frame: 30 days). 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 29 Jan 2025.