Protocol summary

Summary
The purpose of doing this study is to determine the effect of the education program based on the theory of logical action on the high-risk behaviors of people with human papillomavirus virus. This research is a randomized controlled trial (RCT) study, in which the impact of implementing a program based on rational action theory on the amount of high-risk behavior of patients with human papillomavirus virus has examined. The study is a double-blind intervention for the triables group and statistical analyzes. The community of research in this study was patients with human papilloma virus referred to the clinic of sexually transmitted diseases of Razi Hospital affiliated to Tehran University of Medical Sciences. In this study, The research sample consisted of 100 patients with hpv referred to the Clinic of Sexually Transmitted Diseases in Razi Hospital who had the conditions for entering the research during the study and who were randomly selected. The most important criterion for entering the study was the diagnosis of human viral papillomavirus by medicine and the age of 18 years. After selecting the intervention and control group and doing the pre-test from both groups, the control group went through their usual treatment, and the intervention group received the designed education based on the theory of logical action and based on the results of the analysis of the logical action questionnaire as a in person, Individual and face-to-face training sessions for 60 minutes (teaching female patients referred done by a female nurse supervised with a researcher and expert physician) with a built educational tool (booklet)and Using this tool was taught So that they can review the trained subjects during the two months After In-person training until Re-attending the clinic to continue the treatment process and re-examine two months later, Phone tracking was conducted every two weeks,focused on responding to possible patient questions and with emphasizing the main points of the training to be aware of their conditions and re-examine education based on theories. Two months after training, high risk sexual behavior in two intervention and control groups was investigated by using questionnaire again . At the end of the study, 100 samples were examined fully.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016121831453N1
Registration date: 2017-10-08, 1396/07/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-08, 1396/07/16
Registrant information
Name
Nima Pourgholamamiji
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3538 2652
Email address
n-pourgholam@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, University of Medical Sciences of Tehran University of Medical Science
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2018-02-04, 1396/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of educational program based on the theory of reasoned action on sexual risk behaviors in patients with human papillomavirus
Public title
Effect of educational program based on the theory of reasoned action on sexual risk behaviors in patients with human papillomavirus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with human papillomavirus is based psychiatrists. Minimum age of 18 years. Be literate. Patients have mental and physical disabilities. Willing to participate and cooperate in research. Exclusion criteria from the study: At the same time receive specific training with research from other sources in connection with the behavior Prkhtrjnsy Not wanting to continue to participate in the study for any reason. Acute physical and psychological complications during the treatment process Failure to attend training sessions Lack of complete follow up period
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Tehran University of Medical Sciences and Health Services
Street address
No. 21, Tehran University of Medical Sciences, Ghods St. Corner, Keshavarz Blvd,Tehran
City
Tehran
Postal code
Approval date
2017-04-18, 1396/01/29
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2095

Health conditions studied

1

Description of health condition studied
Human Papilloma Virus
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts

Primary outcomes

1

Description
Sexual Risk Behaviors
Timepoint
Before And Two Months After The Intervention.
Method of measurement
Sexual Risk Scale(SRS) With Likert Scale (I Agree, I Think, Disagree)

Secondary outcomes

empty

Intervention groups

1

Description
"The intervention group": designed the training based on the theory of logical action and based on the results of the analysis of the logical action questionnaire as a face-to-face and face-to-face training session for 60 minutes (education of female patients referred by a female nurse supervised by the researcher and A specialist doctor) and a training tool (booklet), and they were trained to use this tool to review the trained subjects during these two months. Following on-the-job training and re-attending the clinic to continue the treatment process and re-examine it two months later, follow-up was conducted on a two-weekly basis focusing on responding to potential patient questions and emphasizing the main points of education, A review of education based on the theory of consciousness. Two months after training, again, high risk sexual behaviors were investigated in two intervention groups using a questionnaire.
Category
Prevention

2

Description
"Control group": After selecting the intervention and control group and doing the pre-test from both groups, the control group underwent their normal medical treatment, two months after the initial referral, again the high risk sexual behavior in the control group was investigated using the questionnaire.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Skin Hospital
Full name of responsible person
Dr Tahere Soori
Street address
NO11, Islamic Unity Street, Area 12,Tehran, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor For Research, University of Medical Sciences of Tehran University of Medical Science
Full name of responsible person
Dr. Ziba Taghizadeh
Street address
No. 21, Tehran University of Medical Sciences, Ghods St. Corner, Keshavarz Blvd,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, University of Medical Sciences of Tehran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
DR Hooman Shahsavari
Position
Faculty - Associate
Other areas of specialty/work
Street address
Zip code: 1419733171, Dr. Mirkhani St. (East Nusrat), Faculty of Nursing and Midwifery Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
hooman.shahsavari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing & Midwifery, Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Doctor Hooman Shahsavari
Position
Medical Surgical Nursing Ph.D.
Other areas of specialty/work
Street address
Tohid Square - St. N. East - Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
hooman.shahsavari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Nima Pourgholam Amiji
Position
Master's Degree In Medical Surgical Nursing
Other areas of specialty/work
Street address
Zip code: 1419733171, Dr. Mirkhani St. (East Nusrat), Faculty of Nursing and Midwifery Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
00
Fax
Email
nimasmt@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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