Determining the effect of motivational interview on self-care (health-promoting behaviors) and quality of life of infertile women with polycystic ovary syndrome
Design
The present study is a clinical trial study of the pragmatic randomized clinical trial type. It consists of an Intervention group of 30 people and a control group of 30 people that will be sampled according to the checklist of the entry criteria. random allocation of samples will be done using random blocking.
Settings and conduct
Sampling being treated at the infertility clinic of imam khomeini hospital . To control the detection bias, the evaluator-blinded method will be used for the evaluators of the outcomes. In order to control the attrition bias, a statistical analysis approach with two separate methods of analysis will be used Intention to treat and pre-protocol and for comparing them with each other. based on the design of the study, the pragmatic clinical trial of client satisfaction will also be measured.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Infertile women 15-40 years old with polycystic ovary syndrome of Iranian nationality,Being literate ,agreement to participate
Exclusion Criteria : Any linguistic or cognitive problems, under the care of a psychiatrist,any history of major depression or major family disputes and grief in the week leading up to the beginning of the study, other chronic illnesses have not occurred,Participation in another study
Intervention groups
Both the intervention group and the control group will receive the standard treatments for women with polycystic ovary syndrome, and the intervention group will receive an additional motivational interview. At the end of the intervention process, a set of training files of the sessions will be given to the members of the control group.
Main outcome variables
The grade of HPLP-II questionnaire score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160619028528N4
Registration date:2020-08-11, 1399/05/21
Registration timing:retrospective
Last update:2020-08-11, 1399/05/21
Update count:0
Registration date
2020-08-11, 1399/05/21
Registrant information
Name
Zeinab Hamzehgardeshi
Name of organization / entity
Mazandaran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.hamzehgardeshi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Motivational Interview on Self-care( health promotional behaviors) and Quality of Life among infertile women with Polycystic Ovary Syndrome
Public title
Effect of motivational interview on self-care and quality of life among infertile women with polycystic ovary syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with polycystic ovary syndrome based on rotterdam criteria according to the diagnosis of an experienced physician
Age (15-40)
Nationality: iranian
Being literate
Agreement to participate in this research
Exclusion criteria:
Having suffered from other chronic diseases during the last 3 months
A consumer of cigarettes, hookah, or alcoholic drinks
Any history of major depression or major family disputes and grief (death of close relatives)in the week leading up to the beginning of the study
Under the care of a psychologist or a psychiatrist at least one month before the start of the study and taking psychiatric medication
Any linguistic or cognitive problems that would prevent the completion of the questionnaire of the research unit
Participation in another study
Age
From 15 years old to 40 years old
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
Sampling in this study the first stage of sampling carried out in order to identify the eligible women with polycystic ovary syndrome will be done through convenience sampling method. Then in the next stage, 60 eligible patients will be assigned to an intervention group (motivational interview recipient) and a control group (routine care) using a computer software and the randomized blocking method with quadruple and hexagonal blocks. To hide the allocation, 60 envelopes in a translucent package with consecutive numbers were used. The packages were then opened in the order in which the participants entered the open study and then the type of the groups of every participant was determined.
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 Mazandaran University of Medical science
Street address
Moalem square, Vice chancellor for research
City
Sari
Province
Mazandaran
Postal code
4843163181
Approval date
2020-05-12, 1399/02/23
Ethics committee reference number
IR.MAZUMS.REC.1399.191
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Health-promoting behaviors
Timepoint
Before the intervention, immediately after the intervention and 8 weeks after the intervention
Method of measurement
Health-promoting lifestyle profile II questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the intervention, immediately after the intervention and 8 weeks after the intervention
Method of measurement
Modified polycystic ovary syndrome health-related quality of life questionnaire
Intervention groups
1
Description
Intervention group: The intervention group consists of 5 group counseling sessions using the social networking application, Whatsapp, for 60-90 minutes. The first part of the session will be the motivational interview section and the second part will be the self-care education program. With regard to the subject of “the quality of life” the following concepts will be discussed: informing the participates about polycystic ovary syndrome, complications, teaching self-care behaviors including diet And exercise. In a motivational interview, exercises such as decision-making balance, readiness cycle for change, increased conflict between self-care behaviors and values, behavior in different situations, and having a vision will be utilized.
Category
Rehabilitation
2
Description
Control group: The control group receives only the center’s usual medical which includes periodic visits, tests, and a one-time educational recommendations for weight loss, exercise, and a healthy diet.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility clinic of Imam Khomeini Hospital in Sari
Full name of responsible person
Dr. Sepide Peyvandi
Street address
Imam Square .Razi Street
City
Sari
Province
Mazandaran
Postal code
33131 48166
Phone
+98 11 3335 0670
Fax
Email
dr_peyvandi@yahoo.com
Web page address
https://imamhospital.mazums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Moalem Street, Vice chancellor for research
City
Sari
Province
Mazandaran
Postal code
48431-63181
Phone
+98 11 4443 4210
Email
majsaeedi @ gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Ansari
Position
Student (MSc)
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Caspian Square. Justice street, 6th Golestan street
City
Sari
Province
Mazandaran
Postal code
4817944693
Phone
+98 11 3320 3800
Fax
Email
َAnsari5664@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Zeinab Hamzehgardesh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Street, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
48431-63181
Phone
+98 11 3336 7342
Fax
+98 11 3337 8915
Email
z.hamzehgardeshi@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Ansari
Position
student (MSc)
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Caspian Square. Justice Street, 6th Golestan Street
City
Sari
Province
Mazandaran
Postal code
4817944693
Phone
+98 11 3323800
Fax
Email
Ansari5664@yahoo.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