Determining the effectiveness of the self-management program on the quality of life and self efficacy of women with polycystic ovary syndrome
Design
The study is a parallel clinical trial with a control group, randomized and without blinding, on 64 eligible women with low quality of life and low self-efficacy. The available sampling method is by using a sequence of random numbers and through the online software, 32 people are assigned to two intervention groups (presentation of 5A self-management program) and 32 people control group (presentation of educational booklets).
Settings and conduct
Baghaeipour Clinic of Shahid Sadoughi Hospital in Yazd, Invitation to study, sampling, random allocation and psychological intervention will conduct by the second investigator under the supervision of the first, third and fourth investigators.
Participants/Inclusion and exclusion criteria
Inclusion:
Diagnosis of polycystic ovary syndrome based on doctor's approval;
At least one year has passed since the diagnosis of the disease;
Age 15-49 years;
Being Iranian;
Being literate in reading and writing;
Having an Android or iOS smart phone;
The possibility of participating in training sessions;
Being the only wife of her husband
Exclusion:
Participation in consulting studies;
The presence of various types of severe mental disorders under drug treatment;
Smoking, drugs and alcohol;
Existence of stressful events during the last 6 months;
Treated with assisted reproductive methods;
limitation in physical activity;
Getting diseases with a special diet;
Intervention groups
For the intervention group, the self-management program based on the 5A model is provided weekly for 8 weeks on the authorized virtual network. For the control group, routine trainings and educational booklets are given regarding polycystic ovary syndrome.
Main outcome variables
Change in the mean quality of life and self-efficacy scores
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230307057652N1
Registration date:2023-03-24, 1402/01/04
Registration timing:prospective
Last update:2023-03-24, 1402/01/04
Update count:0
Registration date
2023-03-24, 1402/01/04
Registrant information
Name
Shahnaz Mojahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1754
Email address
f.goodarzi@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Self-management program on Quality of life and Self efficacy in women with Polycystic ovary syndrome
Public title
Effect of self-management program on Quality of life and Self efficacy in women with Polycystic ovary syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of polycystic ovary syndrome based on the confirmation of a specialist doctor or recorded in the medical record
At least one year has passed since the diagnosis of the disease
Being literate in reading and writing
Having an Android or iOS smart phone
Ability to participate in training sessions
Women who live with their husbands and are the only wives of their husbands
Being Iranian
Age (15-49)
Exclusion criteria:
Participation in consulting studies
Existence of various types of severe mental disorders (psychosis, schizophrenia, etc.) under medical treatment based on medical record information or statements
Smoking, drugs and alcohol
Existence of stressful events during the last 6 months such as immigration, death of relatives, divorce
Treated with assisted reproductive methods
Restrictions on physical activity
Having diseases that require following a special diet (such as phenylketonuria)
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible women are selected by available sampling method and using random number sequence and through online software (www.Random.org/sequences), patients are divided into two intervention groups (providing self-management program 5A) and control group. (presentation of educational booklets) (32 people each) are allocated. Again, the research units in the intervention group are divided into two subgroups by a simple random method.
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 Shahid Sadoughi University of Medical Sciences
Street address
Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2023-03-01, 1401/12/10
Ethics committee reference number
IR.SSU.REC.1401.111
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
Measuring the average quality of life scores in women with polycystic ovary syndrome
Timepoint
At the baseline and completion of the intervention at week 12
Method of measurement
Quality of life questionnaire for women with polycystic ovary syndrome(Cornin and et al.)
2
Description
Measuring mean self-efficacy scores in women with polycystic ovary syndrome
Timepoint
At the baseline and completion of the intervention at week 12
Method of measurement
General Self-Efficacy Scale(Scherer)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group receives the self-management program based on the 5A model in the virtual network. In the Assess stage, after effective communication, height, weight and body mass index are measured. In the Advise stage, Information is given about the abnormal cases obtained from the first stage and the disadvantages of low self-efficacy, low quality of life, disadvantages of increasing body mass index, stress management, adherence to treatment, adoption of a healthy lifestyle, appropriate physical activity and proper diet will be explained. In the Agree stage, suitable and agreed behavioral goals will be adjusted. In the Assist stage, 5 training sessions of 45 to 60 minutes (1 session per week) are offered. In training sessions, about polycystic ovary syndrome, importance of healthy fertility, definition of stress, stress coping techniques, importance of self-care, importance of healthy lifestyle, how to calculate daily calories, how to calculate body mass index and its interpretation, how to measure circumference The waist and its interpretation, the role of nutrition in the treatment and control of disease, the pyramid of food groups, how to read food labels, correct diet recommendations, recommendations for weight loss and appropriate physical activity are given. Also, the checklist related to physical activity or the form to complete the meal plan or the daily checklist of practicing the relaxation technique is recorded by the patient on a daily basis. In the Arrange stage, In the first two weeks, by sending a daily SMS, after two weeks, the practical plan will be reminded twice a week, and then once a week for a month, follow-up will be done to remind the implementation of the practical plan.
Category
Behavior
2
Description
Control group: Self-management routine training is done in the control group. Also, after completing the study, an educational booklet related to polycystic ovary syndrome will be provided to them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghaeipour Clinic of Shahid Sadoughi Hospital
Full name of responsible person
Shahnaz mojahed
Street address
Bouali ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1754
Email
sh_mojahed@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargouei
Street address
Medical sciences Campus, Alam Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3149 2229
Email
abargouei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Shahnaz Mojahed
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bouali ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1754
Email
sh_mojahed@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shahnaz Mojahed
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bouali ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1754
Email
sh_mojahed@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shahnaz Mojahed
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bouali ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1754
Email
sh_mojahed@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
All personal data of study participants can be shared after un identifying
When the data will become available and for how long
After results publication
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions, and people working in industry can also apply to receive it.
Under which criteria data/document could be used
Scientific usage
From where data/document is obtainable
sh_mojahed@yahoo.com
What processes are involved for a request to access data/document