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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04992741
Other study ID # YASEMIN-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date June 15, 2021

Study information

Verified date July 2021
Source University of Gaziantep
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research is a single-blind, randomized, parallel-controlled experimental study designed to determine the effect of Health Belief Model (SIM)-based motivational interviews given to mothers of high school students on mothers' knowledge, beliefs and attitudes towards HPV vaccine. . The hypotheses of the research; The experimental group that received training and motivational interviews within the framework of SIM had higher knowledge and perception of HPV infection and vaccination in the posttest than the control group that did not receive any application.


Description:

Methods: In order to determine the sample size of the study, it was planned to work with a total of 54 patients, at least 27 patients in each group, in the power analysis performed by taking the reference information of the statistician and previous studies, and the study was completed with a total of 63 people (31 in the experimental group, 32 in the control group). The Health Belief Model-based motivational interview will be conducted over the phone and will last 15-20 minutes. One week after each motivational interview, a questionnaire and scale form will be applied to the mothers. After the third meeting, the study will be completed by applying the questionnaire and scale forms. Finally, the questionnaire for measurement will be filled and the research will be completed. The control group will be subjected to routine processing without any intervention. Questionnaire forms were applied to the control group simultaneously with the experimental group. At the end of the study, a single-session motivational interview will be held by the researcher, since the patients in the control group have equal ethical rights. The primary result expected from the study is that mothers' perceptions of the benefit, sensitivity and severity of HPV vaccine increase, and their perception of barriers decreases. The secondary result expected from the study is the increase in mothers' knowledge about HPV infection and vaccination. The tertiary expected outcome of the study is that the mother sees her daughter at risk of HPV infection and decides to have her daughter vaccinated against HPV.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date June 15, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: 1. Those who live in Mersin and are female students in two high schools determined between 15.03.2020 and 15.06.2021., 2. Daughter not vaccinated against HPV, 3. Undecided about getting her daughter vaccinated against HPV, 4. Who doesn't plan to have their daughter vaccinated against HPV, 5. who agreed to participate in the research, 6. Literate, 7. Can speak Turkish,, 8. Having no hearing or sight impairment that will prevent communication,, 9. Able to talk on the phone and use whatsapp,, 10. Participants without a diagnosed psychiatric problem were included in the study.. Exclusion Criteria: 1. Having her daughter vaccinated against HPV, 2. Thinking of getting her daughter vaccinated against HPV, 3. Who refused to participate in the research, 4. Illiterate, 5. Don't speak Turkish, 6. People with hearing or sight impairments that may interfere with communication, 7. Can't talk on the phone and can't use whatsapp, 8. Participants with diagnosed psychiatric problems were excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
education and motivational interview
The control group will remain subject to the routine process without any intervention.

Locations

Country Name City State
Turkey Mersin University Mersin

Sponsors (1)

Lead Sponsor Collaborator
Yasemin ATESEYAN

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Outcome Measures: Health Belief was assessed with the Health Belief Model Scale for Human Papilloma Virus Infection and Vaccination It was developed by Kim (2012) to measure health beliefs towards the HPV vaccine. The scale consists of 4 subscales: benefits (1-3 items), perceived disability (10-14 items), sensitivity (4-5 items), severity (6-9 items) and a total of 14 items. The scale items are interpreted as four-point likert type, with 1 as "not at all", 2 as "a little", 3 as "quite a lot", and 4 as "a lot". The total score range of the scale is 14-56. As the scale score increases, the perception also increases. Change from before implementation, 1th week, 2th week and 3th week of practice
Primary HPV information assessed with HPV information scale The HPV knowledge scale was developed by Waller et al (2013) to measure the knowledge levels of individuals about HPV, HPV vaccine and screening tests. In the scale with a total of 33 items; It consists of four sub-dimensions: general HPV information (1-16 items), HPV screening test information (17-22 items), general HPV vaccine information (23-27 items) and information about the current HPV vaccination program (28-33 items). Participants are expected to mark each item of the scale as "Yes", "No" and "I don't know". In the evaluation phase, each correct answer is scored with=1, while incorrect answers and I don't know are scored with=0. In order to avoid bias in the answers, the correct and incorrect answers were mixed as in the original scale. The total score to be obtained from the scale is between 0-33, and a high score indicates a high level of knowledge about HPV, HPV screening tests and HPV vaccine. Change from before implementation, Change from before implementation, 1th week, 2th week and 3th week of practice
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