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

NCT ID: NCT06021496

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-14
• Study Completion Date: 2023-05-15

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.

Conditions

Early Detection of Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

face to face health education

Intervention Type: BEHAVIORAL

Face-to-face health education with home visit

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.

Group Type: EXPERIMENTAL

online health education

Intervention Type: BEHAVIORAL

online health education with video call

Interventions

face to face health education

Face-to-face health education with home visit

Intervention Type: BEHAVIORAL

online health education

online health education with video call

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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). -

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

OTHER

Sponsor Role: lead

Responsible Party

Serpil Özdemir

Asisstant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

merve gökmen

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health

Locations

University of Health Sciences

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CERVİCAL CANCER

Identifier Type: -

Identifier Source: org_study_id