Gynecological DiseaseNCT05687227
Online Education and Counseling Regarding Gynecological Examination
A study testing Online education and counseling in people with Gynecological Disease, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecological Disease
- What is being tested?
- Online education and counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jun 2021to 7 Sep 2022
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University Application and Research Hospital
Aydin, 09010
About this study
Official title: The Effect on Women's Attitude and Anxiety Levels Regarding Gynecological Examination of Online Education and Counseling
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.
Read the detailed 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.
- Conditions
- Gynecological Disease
- Being tested
- Online education and counseling
- Keywords
- gynecological examination, attitude, anxiety, online, education, counseling
- Medical subject headings
- Genital Diseases, Female, Behavior, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online education and counselingBehavioural
Online education and counseling regarding gynecological examination
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ).
Measured: 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.
Measured: 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.
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.
Measured: 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 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start4 Jun 2021
- Primary completion7 Mar 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological DiseaseStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belma Toptas Acar, Aydin Adnan Menderes University
- Investigators
- BELMA TOPTAŞ ACAR, Res.assist, Principal investigator, belma.toptas@adu.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687227
- Sponsor's protocol ID
- BELMA TOPTAŞ ACAR
- Status last verified
- Jan 2023
- First submitted
- 2 Oct 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I have completed the data of my doctoral thesis. There were 37 experimental groups and 31 controls who completed the study to the end. I wrote my thesis. After making the necessary arrangements with my advisor, I will have my thesis defense exam in December 2022. I will share the summary of my thesis within the month after the defense.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Women's Attitude and Anxiety Levels Regarding Gynecological Examination of Online Education and Counseling
- ClinicalTrials.gov ID
- NCT05687227
- Acronym / sponsor ID
- BELMA TOPTAŞ ACAR
- Conditions
- Gynecological Disease
- Keywords
- gynecological examination, attitude, anxiety, online, education, counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENT GROUP | Experimental | Behavioral: Online education and counselingThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online education and counselingOnline education and counseling regarding gynecological examination | Behavioural | EXPERIMENT GROUP |
Primary outcome
A pre-test was applied to 100 women constituting the sample of the study.
Time frame: up to 9 months.
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 ).
The State and Trait Anxiety Inventory was applied to 100 women constituting the sample of the study.
Time frame: up to 9 months.
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.
2 secondary outcomes
The posttest was applied to 68 people who were pretested within the first 3 months after the pretest was applied.
Time frame: 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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: Yes. I have completed the data of my doctoral thesis. There were 37 experimental groups and 31 controls who completed the study to the end. I wrote my thesis. After making the necessary arrangements with my advisor, I will have my thesis defense exam in December 2022. I will share the summary of my thesis within the month after the defense.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BELMA TOPTAŞ ACAR, Res.assist principal investigator
belma.toptas@adu.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online education and counseling in people with Gynecological Disease, run by Aydin Adnan Menderes 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 7 inclusion and 5 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 18 Jan 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?
A pre-test was applied to 100 women constituting the sample of the study. (time frame: up to 9 months.). The study lists 2 primary outcomes in all. 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 18 Jan 2023.