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The Effect of Face-to-face and Online Health Education on Women's Cervical Cancer Knowledge, Health Beliefs and Screening

Primary Purpose

Early Detection of Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
face to face health education
online health education
Sponsored by
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Early Detection of Cancer focused on measuring Cervical Cancer, Cervical Cancer Screening, Health Education, Online Education, Home Visit

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

The criteria for inclusion in this study are; Volunteering to participate in the study, To be between the ages of 30-65, Being a woman Being married/having an active sexual life, Having the technical equipment to make video calls, To be literate in Turkish, Not having had an HPV DNA / Pap Smear test in the last 5 years. - Exclusion Criteria: The criteria for not being included in this study are; Being pregnant or in the postpartum trimester, Having a family history of cervical cancer, Having had a hysterectomy operation, To have received any previous training on cervical cancer, Having a vaginal infection, To be vaccinated against HPV (3 doses). -

Sites / Locations

  • University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control group

Face-to-face training group

Online training group

Arm Description

Participants in the control group continued to receive standard cervical cancer screening service of the Ministry of Health. No further intervention was made.

In addition to the standard cervical screening service of the Ministry of Health, face-to-face health education through home visits and a reminder by phone call were made once. brochure given

In addition to the standard cervical screening service of the Ministry of Health, online health education via video call and a reminder with a phone call once. A digital brochure was given.

Outcomes

Primary Outcome Measures

HPV Knowledge Scale
HPV Knowledge Scale consists of 4 sub-dimensions and 33 items. Participants score between 0-33.

Secondary Outcome Measures

Cervical Cancer and Pap Smear Test Health Belief Model Scale
Although the scale is graded in a 5-point Likert type, it consists of a total of 35 items. The higher the scores obtained from the scale, the higher the sensitivity, caring and motivation; It means that benefits are perceived high for the perception of benefit, and obstacles are perceived high for the perception of obstacles.

Full Information

First Posted
August 18, 2023
Last Updated
August 29, 2023
Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
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1. Study Identification

Unique Protocol Identification Number
NCT06021496
Brief Title
The Effect of Face-to-face and Online Health Education on Women's Cervical Cancer Knowledge, Health Beliefs and Screening
Official Title
The Effect of Two Different Methods of Health Education on Women's HPV Knowledge, Cervical Cancer Health Belief and Screening
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
March 5, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aim: The aim of this study is to determine the effect of health education given by two different methods on women's knowledge about HPV, cervical cancer health belief and screening test. Materials and Methods: The study was conducted in a parallel groups design as a single-blind randomized controlled trial. The sample consisted of 126 healthy participants, 42 in each volunteer group, who were registered at the Martyr Zafer Çalışkan Family Health Center in Ankara between January and July 2023, and met the inclusion criteria. HPV Knowledge scale, Cervical Cancer and pap Smear Test Health Belief Model Scale and VAS for self-assessment were used in the study. In the study, while the control group received standard care, the face-to-face education group was given health education and brochures through home visits and a reminder interview over the phone; On the other hand, the online training group was given health education and a digital brochure via video call and a reminder meeting was held once. One-way analysis of variance and Kruskal Wallis test were used to compare the data of the three groups after a two-month follow-up, Tukey and Dunn test for multiple comparisons, and Wilcoxon test for in-group comparisons before and after. In addition, two-way analysis of variance and Robust ANOVA were used in group and time comparisons.
Detailed Description
In this randomized controlled trial, participants were assigned to three groups by the block randomization method and the study was conducted in a single-blind parallel groups design. It was carried out at Martyr Zafer Çalışkan Family Health Center between January 2023 and July 2023. The eligibility of female participants between the ages of 30-65 to participate in the study was evaluated by the researcher. The sample size was calculated based on the rate of cervical cancer screening test in Kurt and Akyüz's study. G Power 3.1.9.2 package program was used in the calculation. Taking into account possible data loss, it was decided to add 30% backup participants. In this context, the sample of the study was calculated as 126 participants, 42 in each group. The patients who volunteered to participate in the study were examined whether they met the inclusion criteria other than the level of drug compliance. Written informed consent was obtained from the participants who met the inclusion criteria and a questionnaire form was applied. Participants were assigned to groups using the block randomization method. No intervention was made in the control group. At the end of the following first week, face-to-face and online training was provided with the participants in the online training group, one-to-one home visits, face-to-face training and video calls. Four weeks later, a brief reminder was made by phone call. At the end of eight weeks, a second questionnaire was applied to all groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Detection of Cancer
Keywords
Cervical Cancer, Cervical Cancer Screening, Health Education, Online Education, Home Visit

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised control trial
Masking
Participant
Masking Description
single blind study, participants do not know their group
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Participants in the control group continued to receive standard cervical cancer screening service of the Ministry of Health. No further intervention was made.
Arm Title
Face-to-face training group
Arm Type
Experimental
Arm Description
In addition to the standard cervical screening service of the Ministry of Health, face-to-face health education through home visits and a reminder by phone call were made once. brochure given
Arm Title
Online training group
Arm Type
Experimental
Arm Description
In addition to the standard cervical screening service of the Ministry of Health, online health education via video call and a reminder with a phone call once. A digital brochure was given.
Intervention Type
Behavioral
Intervention Name(s)
face to face health education
Intervention Description
Face-to-face health education with home visit
Intervention Type
Behavioral
Intervention Name(s)
online health education
Intervention Description
online health education with video call
Primary Outcome Measure Information:
Title
HPV Knowledge Scale
Description
HPV Knowledge Scale consists of 4 sub-dimensions and 33 items. Participants score between 0-33.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Cervical Cancer and Pap Smear Test Health Belief Model Scale
Description
Although the scale is graded in a 5-point Likert type, it consists of a total of 35 items. The higher the scores obtained from the scale, the higher the sensitivity, caring and motivation; It means that benefits are perceived high for the perception of benefit, and obstacles are perceived high for the perception of obstacles.
Time Frame
60 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
intervention for cervical cancer
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The criteria for inclusion in this study are; Volunteering to participate in the study, To be between the ages of 30-65, Being a woman Being married/having an active sexual life, Having the technical equipment to make video calls, To be literate in Turkish, Not having had an HPV DNA / Pap Smear test in the last 5 years. - Exclusion Criteria: The criteria for not being included in this study are; Being pregnant or in the postpartum trimester, Having a family history of cervical cancer, Having had a hysterectomy operation, To have received any previous training on cervical cancer, Having a vaginal infection, To be vaccinated against HPV (3 doses). -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
merve gökmen
Organizational Affiliation
Ministry of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Face-to-face and Online Health Education on Women's Cervical Cancer Knowledge, Health Beliefs and Screening

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