Comparison of quality of life scores and disease perception, before and after solution oriented lifestyle counseling in adolescents with polycystic ovary syndrome in the intervention and control groups.
Design
The current study is a counseling educational trial, with a control group with parallel groups, randomized on 76 patients. Sealed envelope site was used for randomization.
Settings and conduct
The study is conducted to determine the effect of the solution-oriented lifestyle program (independent variable) on the quality of life and disease perception (dependent variable) of teenage girls with polycystic ovary syndrome. Sampling is done by the available method among the patients who refer to the women's clinic of Al-Zahra Medical Training Center in Rasht.
Participants/Inclusion and exclusion criteria
Entry requirements : age 18-24, single, body mass index greater than 18.5 and less than 30
Exit conditions: the presence of any kind of organ pathology that prevents physical activity; Previous history of bariatric surgery or planning other strategies for weight loss, use of psychiatric drugs and corticosteroids.
Intervention groups
For the intervention group, lifestyle counseling and educational instructions based on a solution oriented approach in the form of PowerPoint and lecture, question and answer, group discussion and brainstorming and practice at home using the weekly worksheets that are given to them , are presented in 6 sessions. The time of each session is 60 minutes. Sessions are scheduled in groups of 8-10, each group is scheduled one day a week with the agreement of the participants. In the control group, only the orders of the attending physician are performed.
Main outcome variables
Quality of life questionnaire scores ؛ Illness Perception Questionnaire scores؛ Weight and body mass index؛ Total testosterone؛ Fasting blood sugar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240708062362N1
Registration date:2024-07-28, 1403/05/07
Registration timing:registered_while_recruiting
Last update:2024-07-28, 1403/05/07
Update count:0
Registration date
2024-07-28, 1403/05/07
Registrant information
Name
marzie kobraei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4254 9462
Email address
m.kobraei@arakmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of solution-oriented lifestyle counseling on disease perception and quality of life in adolescents with polycystic ovary syndrome
Public title
effect of solution-oriented lifestyle counseling on disease perception and quality of life of polycystic ovary
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-24.
single
body mass index more than 18.5 and less than 30.
People who score higher than the average in the pre-test based on the disease perception questionnaire (BIPQ).
people who get lower than average scores based on the quality of life instrument (APQ-20) in the pre-test
Exclusion criteria:
Having any disease except PCOS
The presence of any kind of organ pathology that prevents physical activity
History of bariatric surgery
Planning other strategies for weight loss
The use of psychiatric drugs
the use of corticosteroids
Age
From 18 years old to 24 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of samples to intervention and control groups is done using block random assignment method. The letter A is assigned to the samples of the intervention group and the letter B is assigned to the samples of the control node. In this method, based on the six states AABB, BBAA, BABA, ABBA, BAAB and ABAB, which are determined by using the site sealed enveloped sequence of blocks, to each of the letters According to the order of production, a number from 1 to 76 is assigned and each letter is placed in an envelope and the number of that letter is written on the envelope. Every time a patient is selected, one of the envelopes is opened according to the number written on the envelope and it is determined that the patient should be placed in the intervention or control group.
According to the type of study, blinding is not possible.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The content of counseling and educational sessions about lifestyle intervention is based on the latest international guidelines for PCOS and the package of interventions to promote the health of adolescents in the treatment of polycystic ovary syndrome by Abdullahian et al. The set of counseling techniques is based on the solution-oriented approach taken from the book of learning solution-oriented therapy by Lutz et al. The validity of the sessions is determined by the psychologist.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran.
City
arak
Province
Markazi
Postal code
646
Approval date
2024-06-09, 1403/03/20
Ethics committee reference number
IR.ARAKMU.REC.1403.113
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Quality of life of adolescents with polycystic ovary syndrome
Timepoint
The beginning of the intervention, immediately after the end of the intervention and 4 and 6 weeks later
Method of measurement
Adolescents’ polycystic ovary syndrome health related quality of life questionnaire
2
Description
Perception disease
Timepoint
The beginning of the intervention, immediately after the end of the intervention and 4 and 6 weeks later
Method of measurement
Brief illness perception questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Counseling and educational instructions in the form of PowerPoint and lecture, question and answer, group discussion and brainstorming, and practice at home using the weekly worksheets that are given to them, are presented in 6 sessions. The time of each session is 60 minutes. Sessions are scheduled in groups of 8-10, each group is scheduled one day a week with the agreement of the participants. The content of the counseling and educational sessions about lifestyle intervention is based on the latest international guidelines for PCOS. The set of counseling techniques is based on the solution oriented approach taken from the book of learning solution oriented therapy by Lutz et al.
Category
Behavior
2
Description
Control group: only executes the doctor's orders.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Medical Education Center
Full name of responsible person
Marzie Kobraei
Street address
Al-Zahra Medical Education Center , in front of Shahid Azodi Stadium, Namjo St,Rasht, Guilan.
City
Rasht
Province
Guilan
Postal code
41937-1311
Phone
+98 13 3336 9324
Email
riasat@gums.ac.ir
Web page address
https://www.gums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpou
Street address
Shahid Shiroudi St., Alam El Hoda St
City
Arak
Province
Markazi
Postal code
646
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Marzie Kobraei
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Basij Square, Parvin Etsami St.
City
Langaroud
Province
Guilan
Postal code
4471875135
Phone
+98 13 4254 9462
Email
marzie.mid1998@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Marzie Kobraei
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Basij Square, Parvin Etsami St., second dead end
City
Langaroud
Province
Guilan
Postal code
4471875135
Phone
+98 13 4254 9462
Email
marzie.mid1998@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Marzie Kobraei
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Basij Square, Parvin Etsami St.,
City
Langaroud
Province
Guilan
Postal code
4471875135
Phone
+98 13 4254 9462
Email
marzie.mid1998@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