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Effectiveness of solution focused brief therapy on students’ perceived self-efficacy regarding Human Papillomavirus vaccination: A Randomized Controlled Trial

Protocol summary

Study aim
Determining the effectiveness of Solution-Focused Brief Therapy on students' perceived self-efficacy regarding Human Papillomavirus vaccination.
Design
This study is an open-label, parallel-group randomized controlled trial. Eligible participants will be allocated to the intervention or control group using block randomization with a 1:1 allocation ratio. The random sequence will be generated using Microsoft Excel. The total sample size is 160 participants (80 per group)
Settings and conduct
The study will be conducted at Mazandaran University of Medical Sciences, Sari, Iran. Participants will be recruited from the Schools of Nursing and Midwifery, Medicine, Dentistry, Paramedical Sciences, Pharmacy, Health, and Advanced Technologies. The intervention sessions will be held in the amphitheater of the School of Pharmacy and Health.
Participants/Inclusion and exclusion criteria
Participants are female students of Mazandaran University of Medical Sciences (Sari Campus) who meet the eligibility criteria and provide written informed consent. Key inclusion criteria include no previous HPV vaccination, low to moderate perceived self-efficacy regarding HPV vaccination, and the ability to attend counseling sessions. Participants will be excluded if they withdraw from the study, receive the HPV vaccine during the study, or fail to complete more than 20% of the study questionnaires.
Intervention groups
Participants will be randomly assigned in a 1:1 ratio to either the intervention or the control group. The intervention group will receive Solution-Focused Brief Therapy (SFBT) delivered in group counseling sessions aimed at enhancing perceived self-efficacy, reducing hesitancy toward HPV vaccination, and strengthening motivation for informed decision-making. The control group will receive routine care.
Main outcome variables
Perceived self-efficacy regarding HPV vaccination.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260704070060N1
Registration date: 2026-08-10, 1405/05/19
Registration timing: registered_while_recruiting

Last update: 2026-08-10, 1405/05/19
Update count: 0
Registration date
2026-08-10, 1405/05/19
Registrant information
Name
Diana Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 1959
Email address
dianaazizi1991@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-08, 1405/05/17
Expected recruitment end date
2026-11-21, 1405/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of solution focused brief therapy on students’ perceived self-efficacy regarding Human Papillomavirus vaccination: A Randomized Controlled Trial
Public title
Effectiveness of solution focused brief therapy on students’ perceived self-efficacy regarding Human Papillomavirus vaccination
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and provision of written informed consent Female students Ability and willingness to participate in face-to-face group counseling sessions Current enrollment in one of the faculties of Mazandaran University of Medical Sciences (Sari Campus) during the 2025–2026 academic year Adequate proficiency in the Persian language to understand the study questionnaires content and participate in the counseling sessions No previous receipt of any dose of the Human Papillomavirus (HPV) vaccine, based on self-report Low to moderate perceived score self-efficacy regarding HPV vaccination, indicating eligibility for the intervention No self-reported history of infection with any HPV genotype or HPV-related malignancies (e.g., cervical cancer) No current use of psychotropic medications, based on self-report No current substance use disorder, based on self-report
Exclusion criteria:
Failure to complete more than 20% of the items in any of the study questionnaires Receipt of any dose of the HPV vaccine at any time during the study period (from screening to the end of follow-up) Participation in any specialized educational or counseling program related to HPV vaccination within the previous six months Presence of severe psychiatric disorders or other mental illnesses diagnosed by a psychiatrist, based on self-report, that may interfere with effective participation in the counseling sessions Pregnancy or intention to become pregnant during the study period Presence of any acute illness or medical condition constituting a contraindication to HPV vaccination (e.g., a history of severe allergic reactions), as confirmed in consultation with an infectious disease specialist unwillingness to continue participation at any stage of the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Participants who meet the eligibility criteria will be randomly allocated to the intervention or control group using block randomization with a 1:1 allocation ratio. The unit of randomization is the individual participant and no stratified randomization will be applied. The random allocation sequence will be generated before participant recruitment by a statistician who is not involved in participant recruitment or outcome assessment, using Microsoft Excel and the RANDBETWEEN function. Participants will be allocated in 40 blocks of four (total sample size = 160). Six possible block arrangements (TTCC, TCTC, TCCT, CCTT, CTCT, and CTTC) will be used, where T represents the intervention group and C represents the control group. Using the RANDBETWEEN function in Excel, a random number between 1 and 6 will be generated 40 times, and each generated number will correspond to one of the six block arrangements. Accordingly, participants will be assigned to the intervention or control group in a balanced manner within each block. To minimize selection bias, allocation concealment will be implemented. After generation of the random allocation sequence, the assignment for each participant will be placed in sequentially numbered, opaque, light-proof, sealed envelopes prepared by an individual who is not involved in participant recruitment. After confirming eligibility and obtaining written informed consent, the envelope corresponding to each participant will be opened sequentially to reveal the assigned group. Therefore, the researcher responsible for participant recruitment will remain unaware of the allocation until the moment of assignment.
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 Mazandaran University of Medical Sciences
Street address
Moallem Square, Deputy of research and technology, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2026-08-05, 1405/05/14
Ethics committee reference number
IR.MAZUMS.REC.1405.184

Health conditions studied

1

Description of health condition studied
This study aims to evaluate the effectiveness of Solution-Focused Brief Therapy (SFBT) on students' perceived self-efficacy regarding human papillomavirus (HPV) vaccination to promote HPV vaccination and prevent HPV infection.
ICD-10 code
Z11.51
ICD-10 code description
Encounter for screening for human papillomavirus (HPV)

Primary outcomes

1

Description
Perceived self-efficacy regarding Human Papillomavirus (HPV) vaccination.
Timepoint
At baseline, immediately after completion of the counseling intervention, and one month after the intervention.
Method of measurement
The primary outcome is perceived self-efficacy regarding Human Papillomavirus (HPV) vaccination, which will be measured using the Health Belief Model Constructs Related to HPV Vaccination Questionnaire at three time points: baseline (before the intervention), immediately after completion of the counseling sessions, and one month after the intervention.

Secondary outcomes

1

Description
Perceived susceptibility to Human Papillomavirus
Timepoint
will be measured at three time points: before the intervention (baseline), immediately after completion of the counseling sessions, and one month after the intervention
Method of measurement
using the Health Belief Model Constructs Related to HPV Vaccination Questionnaire.

2

Description
Perceived severity of the consequences of Human Papillomavirus
Timepoint
will be measured at three time points: before the intervention (baseline), immediately after completion of the counseling sessions, and one month after the intervention
Method of measurement
using the Health Belief Model Constructs Related to HPV Vaccination Questionnaire.

3

Description
Perceived benefits of Human Papillomavirus vaccination
Timepoint
will be measured at three time points: before the intervention (baseline), immediately after completion of the counseling sessions, and one month after the intervention
Method of measurement
using the Health Belief Model Constructs Related to HPV Vaccination Questionnaire.

4

Description
Perceived barriers to Human Papillomavirus vaccination
Timepoint
will be measured at three time points: before the intervention (baseline), immediately after completion of the counseling sessions, and one month after the intervention
Method of measurement
using the Health Belief Model Constructs Related to HPV Vaccination Questionnaire.

5

Description
Satisfaction with the intervention
Timepoint
will be assessed immediately after the final intervention session and at the one-month follow-up
Method of measurement
using the Visual Analog Scale (VAS) for intervention satisfaction

Intervention groups

1

Description
Intervention group: Participants in the intervention group will receive four weekly group counseling sessions based on Solution-Focused Brief Therapy (SFBT), each lasting 45–60 minutes, delivered by the principal investigator certified in SFBT at the amphitheater of the School of Health and Pharmacy. Participants will be divided into four groups of 20. The sessions will incorporate standard SFBT techniques, including the miracle question, exception finding, scaling questions, and coping questions, with the aim of enhancing perceived self-efficacy regarding HPV vaccination, reducing vaccination hesitancy, and strengthening motivation for informed decision-making.
Category
Behavior

2

Description
Control group: At the end of the intervention, the control group will receive one session of routine education on the importance of Human Papillomavirus (HPV) vaccination, delivered virtually via Google Meet.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Mazandaran University of Medical Sciences
Full name of responsible person
Diana Azizi
Street address
No. 42, Moallem 28 Alley, Moallem Street
City
Sari
Province
Mazandaran
Postal code
4817888176
Phone
+98 911 591 3107
Email
dianaazizi1991@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Moallem Square, Deputy of research and technology
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Mazandaran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Diana Azizi
Position
Assistant professor, Department of Reproductive Health and Midwifery, Sexual and Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
No. 42, Moallem 28 Alley, Moallem Street
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3311 1959
Email
dianaazizi1991@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Asana Esmaeeli Basharik
Position
M.Sc. Student of Midwifery Counseling, Student Research committee. Mazandaran University of Medical
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 42, Moallem 28 Alley, Moallem Street
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3311 1959
Email
asanaesmaeeli@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Diana Azizi
Position
Assistant professor, Department of Reproductive Health and Midwifery, Sexual and Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
خیابان معلم، معلم 28، پلاک 42
City
Sari
Province
Mazandaran
Postal code
4817888176
Phone
+98 11 3311 1959
Fax
Email
dianaazizi1991@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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