NCT06021496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

19 days

First QC Date

August 18, 2023

Last Update Submit

August 29, 2023

Conditions

Early Detection of Cancer

Keywords

Cervical CancerCervical Cancer ScreeningHealth EducationOnline EducationHome Visit

Outcome Measures

Primary Outcomes (1)

  • HPV Knowledge Scale

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

    60 days

Secondary Outcomes (1)

  • Cervical Cancer and Pap Smear Test Health Belief Model Scale

    60 days

Study Arms (3)

control group

NO INTERVENTION

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

Face-to-face training group

EXPERIMENTAL

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

Online training group

EXPERIMENTAL

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

Interventions

face to face health educationBEHAVIORAL

Face-to-face health education with home visit

Face-to-face training group
online health educationBEHAVIORAL

online health education with video call

Online training group

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsintervention for cervical cancer
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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). -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsHealth Education

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • merve gökmen

    Ministry of Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single blind study, participants do not know their group
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomised control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Professor

Study Record Dates

First Submitted

August 18, 2023

First Posted

September 1, 2023

Study Start

February 14, 2023

Primary Completion

March 5, 2023

Study Completion

May 15, 2023

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)