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

Early Detection of Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06021496
• Other study ID #: CERVICAL CANCER
• Status: Completed
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: May 15, 2023

Study information

• Verified date: August 2023
• Source: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: May 15, 2023
• Est. primary completion date: March 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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). -

Related Conditions & MeSH terms

• Early Detection of Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• face to face health education
Face-to-face health education with home visit
• online health education
online health education with video call

Locations

Country	Name	City	State
Turkey	University of Health Sciences	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV Knowledge Scale	HPV Knowledge Scale consists of 4 sub-dimensions and 33 items. Participants score between 0-33.	60 days
Secondary	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.	60 days