Online Education and Counseling Regarding Gynecological Examination

NCT05687227 | Completed

• 1 other identifier: BELMA TOPTAŞ ACAR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This research was carried out to determine the effect of online education and counseling on women's attitudes and anxiety levels regarding gynecological examination. The research is a pre-test-post-test, randomized controlled experimental study.

Conditions

Gynecological Disease

Keywords

gynecological examination; attitude; anxiety; online; education; counseling

Outcome Measures

Primary Outcomes (2)

• A pre-test was applied to 100 women constituting the sample of the study.

  Before the online training and counseling, a pre-test was applied to a total of 100 participants, 50 of which were in the experimental group and 50 in the control group. In the pre-test question form created by the researcher in the light of the literature, sociodemographic (questions 1-9), obstetrics (questions 10-13), gynecological characteristics (questions 14-23) and attitudes towards gynecological examination (16 questions ).

  up to 9 months.

• The State and Trait Anxiety Inventory was applied to 100 women constituting the sample of the study.

  The State and Trait Anxiety Inventory, which was developed by Spielberger (1970) and adapted to Turkish by Öner and Le Compte in 1983, was used. The first 20 questions in the scale measure "state anxiety" and the next 20 questions measure "trait anxiety". A score of 0-19 indicates no anxiety. While 20-39 indicates mild anxiety, 40-59 moderate and 60-79 severe anxiety, 80 points are considered as panic. The minimum value to be taken from the state anxiety scale is "0" and the maximum value is "80". The minimum value to be taken from the trait anxiety scale is "0" and the maximum value is "80". As the score increases, the level of anxiety also increases.

  up to 9 months.

Secondary Outcomes (2)

• The posttest was applied to 68 people who were pretested within the first 3 months after the pretest was applied.

  The pre-test implementation phase was completed in 9 months. This process took a total of 1 year, since the last test was applied to the last participants within the 3rd month.

• The State and Trait Anxiety Inventory was applied to 68 people who were pretested within the first 3 months after the pretest was applied.

  The pre-test implementation phase was completed in 9 months. This process took a total of 1 year, since the last test was applied to the last participants within the 3rd month.

Other Outcomes (2)

• Filling in the second post-test questionnaire online in the 6th month after both groups filled out the pre-test questionnaire.

  Since the second posttest form was 3 months after the first posttest form (6 months after the pretest questionnaire), this process was completed in the 15th month from the beginning of the study in total.

• The State and Trait Anxiety Inventory was administered again in the 6th month to 68 people who were posttested in the first 3 months.

  Since the second posttest form was 3 months after the first posttest form (6 months after the pretest questionnaire), this process was completed in the 15th month from the beginning of the study in total.

Study Arms (2)

EXPERIMENT GROUP

EXPERIMENTAL

The trainings were held in groups of 4-6 people. The trainings, which were held in three sessions, were held on the days and times that were convenient for the participants. Since the participants were required to attend all sessions, additional session/sessions were held in case of not being able to attend the trainings. Participants in the control and experimental groups were called and the day they would come for the control was determined, and they went to the gynecology outpatient clinic. The post-test questionnaire was applied to the participants in the control and experimental groups in the first 3 months. Until the end of the research, the participants were told that they could reach the researcher at any time and ask questions. Finally, at the 6th month, a post-test form was applied to the participants.

Behavioral: Online education and counseling

CONTROL GROUP

NO INTERVENTION

No training or counseling was given to the control group. Participants in the control and experimental groups were called and the day they would come for the control was determined, and they went to the gynecology outpatient clinic. The post-test questionnaire was applied to the participants in the control and experimental groups in the first 3 months. Finally, at the 6th month, a post-test form was applied to the participants.

Interventions

Online education and counseling BEHAVIORAL

Online education and counseling regarding gynecological examination

EXPERIMENT GROUP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Applying to Aydın Adnan Menderes University Application and Research Hospital, Gynecology Clinic, Gynecology Clinic,
• Coming to the examination within the first 3 months after the examination,
• Internet access,
• Having a Whatsapp or e-mail address,
• Able to read and write,
• Able to speak and understand Turkish,
• Women in the 18-50 age group are included.

You may not qualify if:

• Having a communication (speech, hearing, etc.) disability,
• Having any psychological illness,
• Pregnant and postpartum,
• Diagnosed with cancer,
• Women who received infertility diagnosis and treatment were excluded.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University Application and Research Hospital

Aydin, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Genital Diseases, Female; Behavior; Anxiety Disorders

Interventions

Counseling

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• BELMA TOPTAŞ ACAR, Res.assist

  belma.toptas@adu.edu.tr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: January 18, 2023
• Study Start: June 4, 2021
• Primary Completion: March 7, 2022
• Study Completion: September 7, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: January 2023- December 2024
• Access Criteria: Klinik Çalışma Raporu (KSS)

Locations

TU (1)