Investigating the effect of increasing awareness based on Acceptance and Commitment Therapy on the quality of life of women with HPV referring to the Kerman women’s oncology subspecialties, 2023
Determining the effect of awareness-raising based on acceptance and commitment on the quality of life of women with HPV
Design
A clinical trial with a control group, without blinding, randomized, on 60 women with papilloma virus. Excel software was used for randomization
Settings and conduct
Available sampling, group consultation room of Afzalipur Hospital, women with HPV
Participants/Inclusion and exclusion criteria
Entry: positive HPV test; less than 6 months have passed since the positive test result; willingness to participate in the study and complete the informed consent form; not having a neurological or mental illness; not suffering from another type of sexually transmitted diseases; being sexually active.
Exit: getting HPV-related cancer while studying; getting pregnant while studying; in case of missing more than one session and not doing homework.
Intervention groups
6 group and face-to-face counseling sessions per week, one 90-minute session. Control without intervention
Main outcome variables
Awareness; acceptance and commitment; quality of life
General information
Reason for update
Acronym
HPV(human papilloma virus)
IRCT registration information
IRCT registration number:IRCT20170611034452N16
Registration date:2023-11-18, 1402/08/27
Registration timing:registered_while_recruiting
Last update:2023-11-18, 1402/08/27
Update count:0
Registration date
2023-11-18, 1402/08/27
Registrant information
Name
Atefeh Ahmadi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5205
Email address
a.ahmadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-14, 1402/08/23
Expected recruitment end date
2025-11-14, 1404/08/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of increasing awareness based on Acceptance and Commitment Therapy on the quality of life of women with HPV referring to the Kerman women’s oncology subspecialties, 2023
Public title
Investigating the effect of increasing awareness based on Acceptance and Commitment Therapy on the quality of life of women with HPV
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Positive HPV test confirmed by gynecological oncology specialist
Less than 6 months have passed since the positive test result
Willingness to participate in the study and complete the informed consent form
Not having any neurological or mental illness
Not suffering from the type Another sexually transmitted disease
Being sexually active
Exclusion criteria:
Getting HPV-related cancer while studying
Getting pregnant while studying
If you miss more than one session and don't do your homework
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Women who meet the inclusion criteria will continue to use the available sampling method until the sample size (at least 30 people) is reached in each group. Using Excel software, they are placed in two intervention and control groups by simple random method (block of four).
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
The work of the research ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences campus, beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-11-04, 1402/08/13
Ethics committee reference number
IR.KMU.REC.1402.288
Health conditions studied
1
Description of health condition studied
Human papilloma virus (HPV) infection
ICD-10 code
R87.810
ICD-10 code description
Cervical high risk human papillomavirus (HPV) DNA test positive
Primary outcomes
1
Description
Quality of Life
Timepoint
The first session of the intervention and 2 weeks after the completion of the intervention sessions
Method of measurement
Quality of life questionnaire (EQUALI-HPV)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They receive 6 group and face-to-face counseling sessions, one 90-minute session per week
Category
Behavior
2
Description
Control group: There is no intervention for the control group
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Women's oncology specialist office
Full name of responsible person
Atefeh Ahmadi
Street address
Kerman University of Medical Sciences, Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 34 3132 5219
Email
a.ahmadi@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Kerman University of Medical Sciences, Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
intdep2@gmail.com
Web page address
http://vresearch.kmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Atefeh ahmadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman University of Medical Sciences, Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Email
a.ahmadi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh ahmadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman University of Medical Sciences, Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Email
a.ahmadi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh ahmadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman University of Medical Sciences, Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Email
a.ahmadi@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
By prior agreement with the corresponding author
From where data/document is obtainable
email
What processes are involved for a request to access data/document