Determining the effect of motivational interviewing on improving the reproductive health of women with human papilloma virus
Design
Clinical trial, with parallel groups, without blinding, phase three, randomized, which will be performed on 62 patients randomly.
Settings and conduct
The study population is women infected with the human papilloma virus, who will be randomly divided into two groups by computer using the random number table method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: infection with human papilloma virus; Reading and writing literacy
Exclusion criteria: unwillingness to continue cooperation during the study; Extreme physical or mental conditions
Intervention groups
Intervention group: will receive 5 individual motivational interview sessions, twice a week, each session lasting 45 minutes.
Control group: The control group only receives routine training about the virus.
Main outcome variables
Sexual dysfunction of women with HPV, anxiety, depression and stress of women with HPV
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230531058348N1
Registration date:2023-06-11, 1402/03/21
Registration timing:registered_while_recruiting
Last update:2023-06-11, 1402/03/21
Update count:0
Registration date
2023-06-11, 1402/03/21
Registrant information
Name
Mina Galeshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 8301
Email address
m.galeshi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-08-11, 1402/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of motivational interviewing on improving the reproductive health of women with HPV
Public title
The effect of motivational interviewing on improving the reproductive health of women with HPV
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Human papilloma virus infection
Reading and writing literacy
Exclusion criteria:
Reluctance to continue cooperation during the study
Extreme physical or mental conditions
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using permutation blocks of size 4. (AABB) in such a way that blocks of 4 consist of random combinations of 2 A (intervention) and 2 B (control). Patients will be randomly assigned to two groups of 31 people using 16 blocks with a size of 4 and a ratio of 1:1. The randomization list is prepared by a statistician.
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 ُShahroud University of Medical Siences
Street address
Shahrud University Of Medical Science, 7 Tir Square, Tehran street
City
shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Approval date
2021-10-10, 1400/07/18
Ethics committee reference number
IR.SHMU.REC.1400.154
Health conditions studied
1
Description of health condition studied
Human papillomavirus
ICD-10 code
R87.810
ICD-10 code description
Cervical high risk human papillomavirus (HPV) DNA test positive
Primary outcomes
1
Description
Sexual dysfunction
Timepoint
Before the intervention and after the completion of 5 sessions
Method of measurement
Female Sexual Function Index (FSFI)
2
Description
Stress, anxiety, depression
Timepoint
Before the intervention and after the completion of 5 sessions
Method of measurement
Stress-anxiety-depression DASS-21
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will receive 5 motivational interview (motivational interviewing in the experimental group runs in accordance with the principles of Miller and Rollnick in the fifth sessions. Contents of the Motivational interviewing session: • First session (dating): A group norms and processes, facilitates the philosophy, practice of freedom, the exercise of the Dimensions of behavior influence, the exercise of change cycle assessment of commitment and confidence. • Second session (emotion): Feelings Practice identifying, practicing and perfecting the exercise of influence dimension and emotional dimension and homework. • The third session (positive and negative aspects of behavior and change): Practice of brainstorming of Short-term and long-term profit and losses, Practice of a complete table of the positive and negative aspects, describe and Practice of corrective options and alternatives one. • Fourth session (values): Definition of values, Practice identifying and prioritizing notch values, practice to define values and value-behavior consistency. • Fifth session (closing Landscape): Summarizing and concluding of previous training Sessions in a Landscape practice and preparation for the start of behavior change programs) individual, twice a week, each session lasting 45 minutes.
Category
Behavior
2
Description
Control group: The control group only receives routine training about the virus
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Women's Clinic of Ayatollah Rouhani Hospital
Full name of responsible person
Zahra Motaghi
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
galeshi_m@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Shahrud University Of Medical Science, 7 Tir Square, Tehran street
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Mina Galeshi
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahrud University Of Medical Science, 7 Tir Square, Tehran street
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 5054
Email
galeshi_m@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Zahra Motaghi
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahrud University Of Medical Science, 7 Tir Square, Tehran street
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 5054
Email
galeshi_m@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mina Galeshi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahrud University Of Medical Science, 7 Tir Square, Tehran street
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 5054
Email
galeshi_m@yahoo.com
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
There is still no plan for its publish
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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