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The effect of educational intervention based on protection motivation theory on mothers' health literacy about human papilloma virus and mothers' intention to vaccinate teenage daughters against human papilloma virus

Protocol summary

Study aim
Determining the effect of educational intervention based on protection motivation theory on mothers' health literacy about human papilloma virus and intention to vaccinate teenage girls
Design
Randomized controlled clinical trial
Settings and conduct
The study will be conducted on women covered by community health service centers affiliated with Neyshabur University of Medical Sciences. First, two centers are randomly selected, then the samples are randomly assigned to the experimental and control groups based on a block of 4. First, a demographic information questionnaire, a researcher-made HPV health literacy questionnaire, a protection motivation and vaccination intention questionnaire are completed for both groups. Then, a 4-session educational intervention is held for mothers in the intervention group. The duration of each educational session is set to 45 minutes and the interval between sessions is set to one week. The questionnaire is completed for both groups immediately and 4 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being Iranian, living in the city of Neyshabur, Literacy, age range of mothers 25-50 years and daughters 9-15 years, not participating in similar studies, no history of receiving HPV vaccine in girls, single girl, no severe stressful event in the past 6 months؛ Exclusion criteria: Mother's employment in healthcare systems,contraindications to receiving the human papillomavirus vaccine in girls
Intervention groups
Eligible persons are divided into two groups. An educational intervention group based on the protection motivation model received 4 weekly training sessions, and the control group without educational intervention only filled pre-test and post-test questionnaires.
Main outcome variables
mothers' HPV health literacy, vaccination intention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241013063345N1
Registration date: 2024-12-15, 1403/09/25
Registration timing: prospective

Last update: 2024-12-15, 1403/09/25
Update count: 0
Registration date
2024-12-15, 1403/09/25
Registrant information
Name
Zohre Mianbandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4222 8344
Email address
zm8092@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on protection motivation theory on mothers' health literacy about human papilloma virus and mothers' intention to vaccinate teenage daughters against human papilloma virus
Public title
The effect of educational intervention based on protection motivation theory on mothers' health literacy about human papilloma virus and mothers' intention to vaccinate teenage daughters against human papilloma virus
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian living in the city of Neyshabur Literacy age range of mothers 25-50 years and daughters 9-15 years not participating in similar studies no history of receiving HPV vaccine In girls single girl no severe stressful event in the past 6 months
Exclusion criteria:
Mother's employment in healthcare systems Contraindications to receiving the human papillomavirus vaccine in girls (including: history of allergic reaction to any type of vaccine, allergy to yeast, people with a weakened immune system)
Age
From 25 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be assigned to the test and control groups based on a block of 4. The sequence of random allocation of people will be done using the site www.sealedenvelope.com. It is worth mentioning that on the mentioned site, 19 blocks are selected from the six possible modes of blocks: AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5) and BAAB (6). Next, people are assigned to groups B and A based on the block corresponding to the selected number. This work continues until the sample volume is completed.
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
Research Ethics committee of school of nursing & midwifery Mashhad University of Medical Sciences
Street address
Khorasan Razavi, Mashhad, Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Kharazmi Educational Complex
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2024-10-15, 1403/07/24
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.071

Health conditions studied

1

Description of health condition studied
Human papillomavirus vaccination
ICD-10 code
Z25.8
ICD-10 code description
Need for immunization against other specified single viral diseases

Primary outcomes

1

Description
HPV health literacy
Timepoint
before starting training, immediately and 4 weeks after training
Method of measurement
Using HPV health literacy questionnaires

2

Description
vaccination intention
Timepoint
before starting training, immediately and 4 weeks after training
Method of measurement
vaccination intention questionnaire

Secondary outcomes

1

Description
protection motivation
Timepoint
Before the start of training, immediately and 4 weeks after training
Method of measurement
Using the protection motivation questionnaire

Intervention groups

1

Description
The educational intervention consisted of 4 sessions, with one session per week and each session lasting 45 minutes. Group discussion, brainstorming, question and answer methods, as well as PowerPoint teaching aids, slide shows, and educational videos will be used in the educational sessions. The educational content will be based on the constructs of the Protection Motivation Theory on the intention to vaccinate against the human papillomavirus and will include the prevalence and importance of human papillomavirus infection, symptoms, complications of this disease, risk factors, causes, and ways of contracting HPV, the effects and complications of the disease on various aspects of health, and the importance of prevention, the importance of vaccination, obstacles, and solutions to overcome them. At the end, an educational pamphlet will also be provided to the spouses.
Category
Prevention

2

Description
Control group: No intervention will be performed
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Neyshabur Urban Health Center
Full name of responsible person
Zohre Mianbandi
Street address
North Ferdowsi St., Behesht St., between 7 and 9 Behesht ،No،77.
City
Neyshabur
Province
Razavi Khorasan
Postal code
93146-63638
Phone
+98 51 4222 8344
Email
zm8092@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mahmoud Shabestari
Street address
University Street, Qureshi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir
Grant name
Mashhad University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zohre Mianbandi
Position
graduate student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3884 6734
Email
zm8092@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Hadizadeh Talasaz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3884 6727
Email
hadizadehtf@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zohre Mianbandi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery School , Shahid Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
zm8092@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Publishing research results in the form of a scientific article
When the data will become available and for how long
The access period begins after the article is published.
To whom data/document is available
The general public and all researchers
Under which criteria data/document could be used
To inform and educate the public about human papillomavirus vaccination and scientific use, citing the article
From where data/document is obtainable
By email to Dr. Fatemeh Hadizadeh Talaasaz, Email:shahnazhadizadeh@yahoo.com
What processes are involved for a request to access data/document
Requests for access to data/documents will be reviewed by the research team.
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