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Genital HygieneNCT05998668

Genital Hygiene Training Provided to Turkish Women

A study testing Genital hygiene training in people with Genital Hygiene and Genital Hygiene Behaviors, run by Inonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose: In the study, it was aimed to determine the effect of genital hygiene training provided to women living in rural areas with a vulvovaginal candidiasis history on genital hygiene behaviors and self-care agency. Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
What is being tested?
Genital hygiene training
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Nov 2022to 30 Jun 2023
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
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • women who tested positive on at least one culture test and received and treatment for vulvovaginal candidiasis in the last year according to the registry of the Family Health Centers, within the age range of 18-49 years, not having a systemic disease, and not being pregnant or puerpera between the dates when the study was conducted.

Who cannot join

  • Those who cannot communicate in Turkish, who are illiterate

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Esra Sabanci Baransel

    Malatya

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Genital Hygiene Training Provided to Turkish Women Living in Rural Areas With a Vulvovaginal Candidiasis History on Genital Hygiene Behaviors and Self-care Agency

Purpose: In the study, it was aimed to determine the effect of genital hygiene training provided to women living in rural areas with a vulvovaginal candidiasis history on genital hygiene behaviors and self-care agency.

Material and methods: This study with a randomized controlled design was conducted with the participation of women who were registered to Family Health Centers located in two villages in the rural areas in the east of Turkey and who had a history of vulvovaginal candidiasis within the last year. The study sample consisted of 114 women in total, 57 of whom were in the intervention group and 57 were in the control group. The women in the intervention group were provided with genital hygiene behaviors training. The study data were collected Identifying Information Form, Genital Hygiene Behavior Inventory (GHBI), and Self-Care Agency Scale (SCAS).

Read the detailed description

Design The study was designed as a randomized controlled trial in which the subjects were randomly assigned to the intervention (receiving genital hygiene training) and the control group.

The study was conducted in the Family Health Centers of two randomly selected villages with a distance of 20-30 km to Van province located in the east of Turkey. These villages are in a rural area and people make their living mostly through farming. Each village had one family health center, and other health institutions were in the provincial center. Family health centers are primary care health institutions which provide reproductive health service for women (healthy woman follow-up, laboratory tests, family planning, education, counselling, etc.). While training is provided within the scope of preventive health services in family health centers, there is no training provided specifically on genital health regarding vulvovaginal candidiasis. Working hours are between 08.00-17.00 every weekday, and there are three family health doctors and three family health professionals (midwife and/or nurse) in these centers.

Sample The study sample consisted of women who tested positive on at least one culture test and received and completed treatment for vulvovaginal candidiasis in the last year according to the registry of the Family Health Centers. The study inclusion criteria were being within the age range of 18-49 years, not having a systemic disease, and not being pregnant or puerpera between the dates when the study was conducted. According to the registration system of the family health centers, 1,400 women who met these criteria were receiving service from these centers.

In order to predict the most suitable sample size for the study, priori-power analysis was performed on a web-based software (https://www.stat.ubc.ca/~rollin/stats/ssize/n2.html). Sample size was calculated to be 57 for each group (57 in the intervention group and 57 in the control group) with 5% margin of error at two-way significance level, 95% confidence interval, 80% power of representing the population and by assuming that the mean score of genital hygiene behaviors, which was 84.51 (standard deviation 5.69), would increase by three points. According to the records of the family health centers where the study was conducted, there were 142 women who received and completed treatment for vulvovaginal candidiasis in the last six months. 142 women were assigned to the intervention and control groups through randomization. Women were listed by the researchers for randomization. According to the list, women with odd numbers were assigned to the intervention group and those with even numbers were included in the control group. The sample selection process carried out in line with CONSORT criteria is presented in Figure 1.

Data Collection Tools In the collection of the study data, Identifying Information Form, Genital Hygiene Behavior Inventory (GHBI), and Self-Care Agency Scale (SCAS) were used.

Identifying Information Form: The form developed by reviewing the literature consisted of questions inquiring about the sociodemographic characteristics of the women (age, educational status, employment status, etc.).

Genital Hygiene Behavior Inventory (GHBI): The scale was developed in Turkish in order to measure genital hygiene behaviors of women, and the validity and reliability study of the scale was conducted by Karahan in 2017. The scale consists of three subscales, which are "general hygiene" (12 items), "menstrual hygiene" (8 items), and "abnormal finding awareness" (3 items). The 23-item and 5-point Likert type scale is scored between 1 and 5. The minimum and maximum scores to be obtained from the scale are 23 and 115. As the score obtained from the scale increases, the women's levels of displaying proper genital hygiene behaviors increase. The Cronbach's alpha internal consistency coefficient of the scale is 0.80.

Self-Care Agency Scale (SCAS): The scale was developed by Kearney and Fleischer in 1979. The Turkish validity and reliability of the scale was conducted by Nahcivan in 1993. It is used to measure individuals' self-care agency levels. Each item of the 35-item and 5-point Likert type scale is scored between 0 ad 4. The minimum and maximum scores to be obtained from the scale are 0 and 140. A high score on the scale shows the individual's high level of self-care agency. The Cronbach's alpha internal consistency of the scale is 0.89.

Procedures The women assigned to the intervention and control groups were called on their telephone numbers registered at the family health center by the researchers to inform them about the study, and they were invited to the family health centers. The pretest data were obtained from the women through the scales used in the study and the questionnaire on their sociodemographic characteristics by face-to-face interviews held by the researchers in the counselling room in the family health centers. Four weeks later, posttest data were collected by following the same procedures.

Following the pretest, "genital hygiene behaviors training" was provided to the women in the intervention group by E.S.B., one the researchers. In addition, a genital hygiene brochure prepared by the researchers which included the same content as the training was given to each participant. The training program was carried out as oral instruction as well as using the demonstration method which is called as "tell-show-do". Individual questions of the women were answered at the end of the training. In the first meeting with the women, 2 sessions of 45 minutes with a 10-minute break were held in the counselling rooms of the relevant family health centers. Two weeks after these sessions, a 45-minute session was held in order to reinforce the training with the same method. No intervention was made to the women in the control group.

Genital hygiene training program was developed by reviewing the literature, and expert opinion was taken for content check before application. In line with the opinions of three academics in the field of nursing, necessary corrections were made, and the training program was finalized. The training program included introduction of reproductive organs, properties of genital discharge, achieving hand and general hygiene, genital infections, hygiene rules in sexual contact, ensuring genital hygiene during menstruation, problems related to genital organs, and coping with genital problems.

Being tested
Genital hygiene training
Keywords
genital hygiene, vulvovaginal candidiasis, genital infection, self-care, rural area
Medical subject headings
Candidiasis, Vulvovaginal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genital hygiene trainingOther

    In the first meeting with the women, 2 sessions of 45 minutes with a 10-minute break were held in the counselling rooms of the relevant family health centers. Two weeks after these sessions, a 45-minute session was held in order to reinforce the training with the same method.

Study groups in NCT05998668
Study groupRoleWhat they receive
genital hygiene trainingExperimentalFollowing the pretest, "genital hygiene behaviors training" was provided to the women in the intervention group by E.S.B., one the researchers. In addition, a genital hygiene brochure prepared by the researchers which included the same content as the training was given to each participant. The training program was carried out as oral instruction as well as using the demonstration method which is called as "tell-show-do". Individual questions of the women were answered at the end of the training. In the first meeting with the women, 2 sessions of 45 minutes with a 10-minute break were held in the counselling rooms of the relevant family health centers. Four weeks after these sessions, a 45-minute session was held in order to reinforce the training with the same method. Four weeks after the data collection tools used in the research were filled in as a pre-test, post-test data were obtained with the same measurement tools.
Receives: Other: Genital hygiene training
Routine checksNo interventionThe researchers applied no initiative to the control group, and the women in the control group solely had the routine checks. The women in the control group filled out all pretest forms (A sociodemographic questionnaire, Genital Hygiene Behavior Inventory (GHBI), and Self-Care Agency Scale (SCAS). The post-test forms (GHBI, SCAS) were re-administered 4 weeks later to women who did not receive any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Genital Hygiene Behavior Inventory (GHBI)

    The scale was developed in Turkish in order to measure genital hygiene behaviors of women, and the validity and reliability study of the scale was conducted by Karahan in 2017. The scale consists of three subscales, which are "general hygiene" (12 items), "menstrual hygiene" (8 items), and "abnormal finding awareness" (3 items). The 23-item and 5-point Likert type scale is scored between 1 and 5. The minimum and maximum scores to be obtained from the scale are 23 and 115. As the score obtained from the scale increases, the women's levels of displaying proper genital hygiene behaviors increase.

    Measured: Change from genital hygiene behavior levels at 4 weeks

Secondary outcomes (1)
  1. Self-Care Agency Scale (SCAS)

    The scale was developed by Kearney and Fleischer in 1979. The Turkish validity and reliability of the scale was conducted by Nahcivan in 1993. It is used to measure individuals' self-care agency levels. Each item of the 35-item and 5-point Likert type scale is scored between 0 ad 4. The minimum and maximum scores to be obtained from the scale are 0 and 140. A high score on the scale shows the individual's high level of self-care agency.

    Measured: Change from self-care agency levels at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start22 Nov 2022
  3. Primary completion22 Feb 2023
  4. Study completion30 Jun 2023

Resources

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
Crossover
Model description
The study was desined as a randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05998668
Sponsor's protocol ID
2022/3782
Status last verified
Aug 2023
First submitted
9 Aug 2023
Last updated
21 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Genital hygiene training in people with Genital Hygiene and Genital Hygiene Behaviors, 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 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: finished, as of the sponsor's last update on 21 Aug 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?

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 Inventory (GHBI) (time frame: Change from genital hygiene behavior levels at 4 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 21 Aug 2023.

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