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

August 29, 2023 updated by: Serpil Özdemir, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

The Effect of Two Different Methods of Health Education on Women's HPV Knowledge, Cervical Cancer Health Belief and Screening

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

The criteria for inclusion in this study are;

  1. Volunteering to participate in the study,
  2. To be between the ages of 30-65,
  3. Being a woman
  4. Being married/having an active sexual life,
  5. Having the technical equipment to make video calls,
  6. To be literate in Turkish,
  7. 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;

  1. Being pregnant or in the postpartum trimester,
  2. Having a family history of cervical cancer,
  3. Having had a hysterectomy operation,
  4. To have received any previous training on cervical cancer,
  5. Having a vaginal infection,
  6. To be vaccinated against HPV (3 doses). -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Participants in the control group continued to receive standard cervical cancer screening service of the Ministry of Health. No further intervention was made.
Experimental: Face-to-face training group

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
Behavioral: face to face health education
Face-to-face health education with home visit
Experimental: Online training group
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.
Behavioral: online health education
online health education with video call

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV Knowledge Scale
Time Frame: 60 days
HPV Knowledge Scale consists of 4 sub-dimensions and 33 items. Participants score between 0-33.
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical Cancer and Pap Smear Test Health Belief Model Scale
Time Frame: 60 days
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.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Investigators

  • Principal Investigator: merve gökmen, Ministry of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2023

Primary Completion (Actual)

March 5, 2023

Study Completion (Actual)

May 15, 2023

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERVİCAL CANCER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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