NCT04992741

Brief Summary

This research is a single-blind, randomized, parallel-controlled experimental study designed to determine the effect of Health Belief Model (SIM)-based motivational interviews given to mothers of high school students on mothers' knowledge, beliefs and attitudes towards HPV vaccine. . The hypotheses of the research; The experimental group that received training and motivational interviews within the framework of SIM had higher knowledge and perception of HPV infection and vaccination in the posttest than the control group that did not receive any application.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

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

September 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 28, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
Last Updated

August 5, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

July 28, 2021

Last Update Submit

July 28, 2021

Conditions

Keywords

HPV, Health Belief Model, Motivational Interview, Nursing

Outcome Measures

Primary Outcomes (2)

  • Primary Outcome Measures: Health Belief was assessed with the Health Belief Model Scale for Human Papilloma Virus Infection and Vaccination

    It was developed by Kim (2012) to measure health beliefs towards the HPV vaccine. The scale consists of 4 subscales: benefits (1-3 items), perceived disability (10-14 items), sensitivity (4-5 items), severity (6-9 items) and a total of 14 items. The scale items are interpreted as four-point likert type, with 1 as "not at all", 2 as "a little", 3 as "quite a lot", and 4 as "a lot". The total score range of the scale is 14-56. As the scale score increases, the perception also increases.

    Change from before implementation, 1th week, 2th week and 3th week of practice

  • HPV information assessed with HPV information scale

    The HPV knowledge scale was developed by Waller et al (2013) to measure the knowledge levels of individuals about HPV, HPV vaccine and screening tests. In the scale with a total of 33 items; It consists of four sub-dimensions: general HPV information (1-16 items), HPV screening test information (17-22 items), general HPV vaccine information (23-27 items) and information about the current HPV vaccination program (28-33 items). Participants are expected to mark each item of the scale as "Yes", "No" and "I don't know". In the evaluation phase, each correct answer is scored with=1, while incorrect answers and I don't know are scored with=0. In order to avoid bias in the answers, the correct and incorrect answers were mixed as in the original scale. The total score to be obtained from the scale is between 0-33, and a high score indicates a high level of knowledge about HPV, HPV screening tests and HPV vaccine.

    Change from before implementation, Change from before implementation, 1th week, 2th week and 3th week of practice

Study Arms (2)

Experimental

EXPERIMENTAL

Health Belief Model Based Motivational Interview Group The application will be made by the researcher who has been trained in motivational interviewing techniques. Motivational interviews based on Health Belief Model will be made by telephone to mothers who have daughters studying in high school. There will be 3 interviews with mothers based on the benefits, barriers, sensitivity and severity perception structures of the Health Belief Model regarding HPV infection and vaccination, and each interview will last 15-20 minutes. One week after each interview, the questionnaire/scale forms will be sent via whatsapp and applied.

Other: education and motivational interview

other

NO INTERVENTION

The control group will remain subject to the routine process without any intervention.

Interventions

The control group will remain subject to the routine process without any intervention.

Experimental

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Those who live in Mersin and are female students in two high schools determined between 15.03.2020 and 15.06.2021.,
  • Daughter not vaccinated against HPV,
  • Undecided about getting her daughter vaccinated against HPV,
  • Who doesn't plan to have their daughter vaccinated against HPV,
  • who agreed to participate in the research,
  • Literate,
  • Can speak Turkish,,
  • Having no hearing or sight impairment that will prevent communication,,
  • Able to talk on the phone and use whatsapp,,
  • Participants without a diagnosed psychiatric problem were included in the study..

You may not qualify if:

  • Having her daughter vaccinated against HPV,
  • Thinking of getting her daughter vaccinated against HPV,
  • Who refused to participate in the research,
  • Illiterate,
  • Don't speak Turkish,
  • People with hearing or sight impairments that may interfere with communication,
  • Can't talk on the phone and can't use whatsapp,
  • Participants with diagnosed psychiatric problems were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Mersin, 33343, Turkey (Türkiye)

Location

Related Publications (1)

  • Ateseyan Y, Gungormus Z. Web and theory-based motivational interviews in encouraging mothers for HPV vaccination of their daughters: A randomized controlled study. J Pediatr Nurs. 2024 Sep-Oct;78:e279-e288. doi: 10.1016/j.pedn.2024.07.016. Epub 2024 Jul 26.

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Educational StatusMotivational Interviewing

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Yasemin Ateşeyan

    Turkey, Mersin University, Mersin, Yenişehir, Turkey, 33343

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The two high schools included in the research will be determined as experimental and control groups by lottery method. By an independent researcher who was not involved in the study, 27 mothers from both schools who agreed to participate in the study will be selected by lottery method. Selected mothers will be called one by one by phone to be informed about the research, and the "Informed Consent Form" will be filled in via whatsapp and survey/scale forms will be applied. Participants will be blinded. The researcher (YA) cannot be blinded due to the nature of the research. When the research is completed, the data will be transferred to the computer environment by an independent researcher who does not know the A and B groups and the data will be analyzed by a statistician and the findings will be reported
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

July 28, 2021

First Posted

August 5, 2021

Study Start

September 1, 2020

Primary Completion

January 1, 2021

Study Completion

June 15, 2021

Last Updated

August 5, 2021

Record last verified: 2021-07

Locations