Genital Hygiene Training Provided to Turkish Women
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05998668 |
Recruitment Status :
Completed
First Posted : August 21, 2023
Last Update Posted : August 21, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Genital Hygiene Genital Hygiene Behaviors Self-care Agency | Other: Genital hygiene training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 114 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | The study was desined as a randomized controlled trial |
Masking: | Single (Participant) |
Primary Purpose: | Supportive Care |
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 |
Actual Study Start Date : | November 22, 2022 |
Actual Primary Completion Date : | February 22, 2023 |
Actual Study Completion Date : | June 30, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: genital hygiene training
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. 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.
|
Other: Genital hygiene 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: Routine checks
The 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.
|
- Genital Hygiene Behavior Inventory (GHBI) [ Time Frame: Change from genital hygiene behavior levels at 4 weeks ]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.
- Self-Care Agency Scale (SCAS) [ Time Frame: Change from self-care agency levels at 4 weeks ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Women between the ages of 18-49 years |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Those who cannot communicate in Turkish, who are illiterate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05998668
Turkey | |
Esra Sabanci Baransel | |
Malatya, Turkey |
Responsible Party: | Esra SABANCI BARANSEL, Assistant professor, Inonu University |
ClinicalTrials.gov Identifier: | NCT05998668 |
Other Study ID Numbers: |
2022/3782 |
First Posted: | August 21, 2023 Key Record Dates |
Last Update Posted: | August 21, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
genital hygiene vulvovaginal candidiasis genital infection self-care rural area |
Candidiasis Candidiasis, Vulvovaginal Mycoses Bacterial Infections and Mycoses Infections Vulvovaginitis Vaginitis Vaginal Diseases |
Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Vulvitis Vulvar Diseases Genital Diseases |