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Not yet recruitingNCT06509529Updated Jul 19, 2024

The Effect of Motivational Interviewing Based on the COM-B Model

An interventional study of Motivational Interviewing Based on the COM-B Model in Cervical Cancer, sponsored by T.C. ORDU ÜNİVERSİTESİ. Not yet recruiting. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by T.C. ORDU ÜNİVERSİTESİ · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
Female
01

Study summary

This research will be conducted to determine the effect of motivational interviewing based on the COM-B model on women's cervical cancer health beliefs and participation in screening.

Read the detailed description

Cancer is an important public health problem in terms of mortality and morbidity in the world and in our country, and ranks second among the causes of death. It can reduce the mortality and morbidity rate in cancer with early diagnosis and screening studies. One of the cancers for which early diagnosis and screening studies are carried out in women is cervical cancer, and it is the 4th most frequently diagnosed cancer type that causes death in women. Although early diagnosis and screening studies are carried out, women do not participate in enough cervical cancer screenings for different reasons. Interventions are needed to increase women's motivation to participate in screening. This research will be conducted to determine the effect of motivational interviewing based on the COM-B model on women's cervical cancer health beliefs and participation in screening. The research is planned as a parallel group single-blind randomized controlled experimental study and will be conducted on women between the ages of 30-65 who are registered at Altınordu Central Family Health Center in Ordu Province. The population of the research will be women between the ages of 30-65 who are registered at Altınordu Central Family Health Center, and the sample will be 74 women who meet the research criteria and agree to participate in the research. The data of the research will be collected with the "Information Form", "Cervical Cancer and Pap Smear Test Health Belief Model Scale", "Cervical Cancer Screening Status Evaluation Form" and "Satisfaction Evaluation Form". A motivational interview program based on the COM-B Model will be applied to the women in the experimental group for 1 month (1st week face-to-face, 2nd, 3rd and 4th weeks online). No intervention will be applied to the control group during the research process. The analysis of the data will be done in a computer environment by an expert statistician. Necessary institutional permissions and ethics committee approval will be obtained for the research.

02

Conditions studied

  • Cervical Cancer

Keywords

  • Cervical Cancer
  • Motivational Interviewing
  • Early Diagnosis and Screening
  • Health Beliefs
  • Nursing
  • COM-B Model
03

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Registered at Altınordu Central Family Health Center,
  • A woman,
  • Between 30-65 years of age,
  • The one who is married,
  • Have not had a Pap Smear test in the last 5 years,
  • Has a smart phone
  • Has an internet connection,
  • Open to communication and collaboration,
  • Women who volunteer to participate in the study will be included in the study.

Exclusion criteria

Exclusion Criteria:

  • Who had total hysterectomy surgery,
  • The pregnant one,
  • Those diagnosed with cervical cancer and
  • Women with a psychiatric diagnosis will be excluded from the study.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Motivational interviews based on the COM-B Model will be given to the women in the experimental group.

    Other: Motivational Interviewing Based on the COM-B Model

  • No intervention
    control group

    They will receive routine cancer screening information provided by the institution.

Interventions

  • OtherMotivational Interviewing Based on the COM-B Model

    Motivational Interviewing Based on the COM-B Model will be applied to the women in the experimental group.

05

What researchers measure

Primary outcomes

  1. "Cervical Cancer and Pap Smear Test Health Belief Model Scale"

    The scale was developed by Güvenç et al. (2011). Higher scores from the scale indicate increased sensitivity, caring and motivation; It indicates that benefits are perceived as high for benefit perception and obstacles are perceived as high for obstacle perception.

    Time frame: 0th month and 1st month.

  2. Status of Cervical Cancer Screening

    This form was prepared by the researcher and will evaluate women's status of being screened for cervical cancer.

    Time frame: 0th month and 1st month.

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06509529
Lead sponsor
T.C. ORDU ÜNİVERSİTESİ
Responsible party
Hacer Gok Ugur (Associate Professor., T.C. ORDU ÜNİVERSİTESİ) — Principal investigator
First posted
Jul 19, 2024
Start date
Aug 15, 2024 (estimated)
Primary completion
Dec 30, 2024 (estimated)
Completion
Jan 30, 2025 (estimated)
Last update
Jul 19, 2024

Study contacts

Hacer GÖK UĞUR, Assoc.Prof.
Contact
hacer32@gmail.com
04522265200
Züleyha Çakır, Nurse
Contact
cakirzuleyha.379@gmail.com
04522265200
Hacer GÖK UĞUR, Assoc.Prof.
study director · T.C. ORDU ÜNİVERSİTESİ

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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