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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05687227
Other study ID # BELMA TOPTAS ACAR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 4, 2021
Est. completion date September 7, 2022

Study information

Verified date January 2023
Source Aydin Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The research is a pre-test-post-test, randomized controlled experimental study. Simple randomization method was used to assign the participants to the groups. The sample consisted of a total of 100 women (experimental group: 50 women and control group: 50 women). The study was carried out with women who applied to Aydın Adnan Menderes University Application and Research Hospital, Gynecology Clinic, Gynecology Outpatient Clinic and met the study criteria.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 7, 2022
Est. primary completion date March 7, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Applying to Aydin 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Online education and counseling
Online education and counseling regarding gynecological examination

Locations

Country Name City State
Turkey Aydin Adnan Menderes University Application and Research Hospital Aydin

Sponsors (1)

Lead Sponsor Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Filling in the second post-test questionnaire online in the 6th month after both groups filled out the pre-test questionnaire. Online training and counseling about gynecological examination was applied to the experimental group. No counseling or training was given to the control group. The post-test form was applied to the participants online. The same questions regarding the gynecological examination included in the posttest questionnaire, which must be completed within the first 6 months after the pretest is completed. 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.
Other The State and Trait Anxiety Inventory was administered again in the 6th month to 68 people who were posttested in the first 3 months. 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 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.
Primary 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.
Primary 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 The posttest was applied to 68 people who were pretested within the first 3 months after the pretest was applied. Online training and counseling about gynecological examination was applied to the experimental group. No counseling or training was given to the control group. Trainings on gynecological examination were carried out in 3 sessions by determining the days and hours that women are suitable for via Google Meet. The trainings were carried out in groups of 4-6 people. The women in the experimental and control groups who will come for the examination were reached in advance and information was obtained about when they would come, and they went to the gynecology outpatient clinic on the day they would come for the check-up. The post-test form was applied to the participants face to face and the form was filled by the participant himself. The post-test form included attitude questions about gynecological examination. 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.
Secondary 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 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. 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.
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