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The Impact of a Spiritual Health-Based Intervention on the Awareness, Attitude, and Intention to Receive the Human Papillomavirus (HPV) Vaccination in Female University Students

Protocol summary

Study aim
Determining the effect of a combined intervention based on spiritual health on knowledge, attitude, and intention of human papillomavirus vaccination in female students
Design
The field trial with intervention and control groups, with parallel groups, randomized using a random number table method, conducted spiritual health education intervention and papillomavirus education on 36 students and 36 students were considered as the control group
Settings and conduct
Female students will complete questionnaires before attending six 45-minute sessions (30 minutes on spiritual health, 15 minutes on HPV) held twice a week at the nursing faculty or dormitory. Content is based on Jafar Bolhari's "Teaching Spiritual Skills for Trainers" and includes group discussions, Q&A, slide presentations, session reviews, and motivational SMS messages. The control group will receive life skills training.
Participants/Inclusion and exclusion criteria
1. Female gender and and age between 18 and 25 years 2. Undergraduate medical students in Mashhad 3. Consent to participate in the study 4. No previous or current infection with the HPV virus 5. No vaccination against the HPV virus 6. No debilitating physical illness 7. No debilitating mental disorders 8. No previous participation in similar courses
Intervention groups
The intervention group, comprising female dormitory students, will attend six 45-minute sessions held twice a week. These sessions cover spiritual health topics (e.g., self-awareness, spiritual problem-solving, forgiveness, meditation) and HPV education (virus basics, transmission, health effects, prevention, vaccination). Motivational SMS messages will precede each session. The control group will receive life skills training and an HPV pamphlet instead.
Main outcome variables
Increasing awareness about HPV Improving attitudes about HPV Willingness to receive HPV vaccine

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250106064288N1
Registration date: 2025-01-31, 1403/11/12
Registration timing: prospective

Last update: 2025-01-31, 1403/11/12
Update count: 0
Registration date
2025-01-31, 1403/11/12
Registrant information
Name
Faezeh Ehsanfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3823 0090
Email address
ehsanfarfz4022@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of a Spiritual Health-Based Intervention on the Awareness, Attitude, and Intention to Receive the Human Papillomavirus (HPV) Vaccination in Female University Students
Public title
"The Impact of Spiritual Health Education on Awareness and Intention to Vaccinate Against Human Papillomavirus"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender and over 18 years old. Undergraduate medical students in Mashhad. Consent to participate in the study. No previous or current infection with the HPV virus. No vaccination against the HPV virus. No debilitating physical illness. No debilitating mental disorders. No previous participation in similar courses.
Exclusion criteria:
Reluctance to continue participation at any time during the study. The occurrence of any illness that may prevent the individual from continuing participation in the study. Relocation outside the study area. Simultaneous participation in a similar training course.
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple randomization. The randomization unit is the individual. The randomization tool is a random number table. First, the control group is selected and the questionnaires are completed by them. Then the intervention group will be selected.
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 Mashhad University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences, Shahid Dr. Kharazmi Educational Complex, East Gate of Ferdowsi University of Mashhad, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2024-11-19, 1403/08/29
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.079

Health conditions studied

1

Description of health condition studied
Human Papilloma Virus (HPV)
ICD-10 code
B97.7
ICD-10 code description
Papillomavirus as the cause of diseases classified elsewhere

Primary outcomes

1

Description
The main outcome of the study is the effect of intellectual health intervention training program based on spiritual health and HPV education on students.
Timepoint
Initially, before the intervention, the questionnaires will be completed by the female students and then the intervention will take place. One month after the intervention, the female students will complete the questionnaires again.
Method of measurement
Kazrani and Abadi Awareness and Attitude Questionnaire (1398)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group consists of a selection of students from the female dormitory residents who will participate in the spiritual health training intervention, which includes training in areas such as spiritual self-awareness, problem-solving with a spiritual approach, forgiveness skills for repairing interpersonal relationships, and meditation as a spiritual skill. Additionally, HPV education will cover topics such as the introduction of the HPV virus and its prevalence, methods of transmission, its impact on health, at-risk individuals, clinical symptoms, various prevention methods, the importance of vaccination, and addressing concerns and misconceptions about vaccine safety. This will be conducted over six sessions of 45 minutes each, twice a week, at the Nursing and Midwifery School. Before each session, participants will receive a motivational text message to facilitate learning.
Category
Behavior

2

Description
Control group: The control group will serve as a comparative group for the intervention group. In this case, the control group will function similarly to the intervention group, with the difference that instead of the spiritual health and HPV education program, they will receive life skills training and a pamphlet about HPV.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences Nursing and Midwifery Faculty
Full name of responsible person
Dr. Hamidreza Zendehtalab
Street address
Azadi Square, East Door of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Kharazmi Martyr Educational Complex
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Fax
Email
nms.pr@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaqodi
Street address
Mashhad, Daneshgah Street, next to Hoveyzeh Cinema, University of Medical Sciences, Third Floor, Vice Chancellor for Research and Technology of the University
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
TafaghodiM@mums.ac.ir
Grant name
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
hamidreza zendehtalab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Azadi Square, East Door of Ferdowsi University of Mashhad, University Campus, Dr. Kharazmi Martyr Educational Complex
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
zendehtalabhr@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Zendehtalab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Azadi Square, East Door of Ferdowsi University of Mashhad, University Campus, Dr. Kharazmi Martyr Educational Complex
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
nms.pr@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Faezeh Ehsanfar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Kharazmi Educational Complex, East Door of Ferdowsi University of Mashhad, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
ehsanfarFZ4022@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of participant information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some of the participant data, such as information related to the main outcome or the like, may be shared.
When the data will become available and for how long
Data is permanently accessible.
To whom data/document is available
The ethics committee and referees and editor of the journal that will publish the resulting article.
Under which criteria data/document could be used
Review and monitor the proper implementation of the plan and publication of findings
From where data/document is obtainable
Supervisor
What processes are involved for a request to access data/document
By formal request via email and by decision of the research team
Comments
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