Determining the effect of education based on health belief model on sexual self-care of women with human papilloma virus
Design
A randomized clinical trial with a control group, which will be conducted on 70 women infected with human papilloma virus.
No blinding due to being educational.
Allocating people to two intervention and control groups will be done using blocks.
Settings and conduct
The place of study will be Imam Khomeini Hospital and Arash Women's General Hospital. The researcher will first provide sufficient information about the research to the women; including the title of the research, objectives, the inclusion criteria, how to conduct the study. Then, people will be assigned to one of the intervention or control groups using the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Positive HPV-DNA test, Having Iranian nationality, Being married, Being 15-49 years old, Literacy for reading and writing. Exclusion criteria: Unwillingness to participate in research; having chronic psychiatric disorders and problems, suffering from known malignant diseases; history of participation in educational or counseling classes (STIs).
Intervention groups
For the intervention group, 4 training sessions of 45 to 60 minutes will be held (once a week).
After the completion of the intervention and obtaining the results, the educational content will also be available to the control group.
Main outcome variables
improving sexual self-care of women with human papilloma virus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231223060503N1
Registration date:2024-01-01, 1402/10/11
Registration timing:prospective
Last update:2024-01-01, 1402/10/11
Update count:0
Registration date
2024-01-01, 1402/10/11
Registrant information
Name
Masoumeh Namazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4221
Email address
mnamazi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-30, 1402/11/10
Expected recruitment end date
2024-02-29, 1402/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on health belief model on sexual self-care of women with human papilloma virus
Public title
The effect of education on sexual self-care of women with human papilloma virus
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Positive HPV-DNA test
Having Iranian nationality
being married
Being 15-49 years old
Literacy for reading and writing
Exclusion criteria:
Unwillingness to participate in research
suffering from chronic psychiatric disorders and problems
suffering from known malignant diseases
history of participating in educational or counselling classes of STIs
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocating people to two intervention and control groups will be done using blocks (AABB/BBAA/ABAB/BAAB/ABBA/BBBA).
The randomization unit will be individual.
The randomization tool for choosing the block unit will be dice.
Due to the present study is an educational type, there will be no possibility of blinding.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Nursing and Midwifery Faculty and rehabilitation Faculty of Tehran University of
Street address
Keshavarz Blvd., Qods St., Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2023-12-19, 1402/09/28
Ethics committee reference number
IR.TUMS.FNM.REC.1402.186
Health conditions studied
1
Description of health condition studied
Sexual self-care of women with human papilloma virus
ICD-10 code
B97.7
ICD-10 code description
Papillomavirus as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Sexual Self-Care
Timepoint
Before the intervention, immediately after the end of the intervention, eight weeks after the end of the intervention
Method of measurement
Female Sexual Health Self-care (FSHS) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We will have an intervention group that will receive educational materials based on the health belief model during 4 sessions weekly of 45 to 60 minutes with groups of 10-15 people. The educational components include an explanation of the human papilloma virus, its prevalence in the world and Iran, the definition of self-care and sexual self-care and its importance and impact on women's lives, an explanation of the complications of not performing a pap smear test and the lack of vaccination against non-infected strains, its impact on marital life and quality of life, the problems of having multiple sexual partners, sharing common experiences and their solutions with each other, various sources of information about human papillomavirus, asking from women to express their fears about symptoms and providing ways based on sexual self-care and … .
Category
Behavior
2
Description
Control group: In the control group, which includes women infected with the human papilloma virus and have inclusion criteria, no intervention will be performed.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Women's Clinic, Imam Khomeini Hospital, Tehran
Full name of responsible person
Dr. Masoumeh Namazi
Street address
End of Keshavarz Boulevard, Imam Khomeini Hospital Complex