NCT05998668

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 9, 2023

Last Update Submit

August 17, 2023

Conditions

Keywords

genital hygienevulvovaginal candidiasisgenital infectionself-carerural area

Outcome Measures

Primary Outcomes (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.

    Change from genital hygiene behavior levels at 4 weeks

Secondary Outcomes (1)

  • Self-Care Agency Scale (SCAS)

    Change from self-care agency levels at 4 weeks

Study Arms (2)

genital hygiene training

EXPERIMENTAL

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

Routine checks

NO INTERVENTION

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.

Interventions

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.

genital hygiene training

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen between the ages of 18-49 years
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Those who cannot communicate in Turkish, who are illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Sabanci Baransel

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsVulvovaginitisVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVulvitisVulvar DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: The study was desined as a randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 21, 2023

Study Start

November 22, 2022

Primary Completion

February 22, 2023

Study Completion

June 30, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations