Protocol summary
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Study aim
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Determining and Comparing the Effectiveness of Mind-Body Intervention in Two Virtual-in-person Methods on Quality of Life in Women with Polycystic Ovary Syndrome
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Design
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Clinical trial of control group, with randomized double-blind randomized parallel groups on 60 patients. Use of random number table for randomization
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Settings and conduct
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After obtaining informed consent from women undergoing polycystic ovary syndrome, they were then randomly assigned to two groups of virtual mind-body intervention (n = 30) and control group (n = 30). The two groups of 15 people are divided.
The intervention group received 8 sessions of 2-hour counseling with physical therapy approach.Also, fasting blood glucose was measured in the laboratory of the Diabetes Polyclinic twice for the beginning of the study and at the end of week 8 in both groups for free.
Yazd Diabetes Clinic Study Place
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Participants/Inclusion and exclusion criteria
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Married women of childbearing age, Iranian, literate, for both intervention groups, virtual and mobile, and Internet or iPhone Operating System(ios) for both groups, Polycystic Ovary Syndrome based on Rotterdam criteria and treated Being in a diabetes clinic.Willingness to have a fasting blood sugar test before the study and after the end of week 8
Exclusion: Participation in another study, self-reported history of other chronic mental and physical illnesses, use of other medications
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Intervention groups
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Intervention group: Virtual physical counseling group. Control group: Physical Mental Counseling (8 sessions of two-hour physical counseling) before and after the eighth and twelfth week of quality of life in women with polycystic ovary syndrome
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Main outcome variables
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Quality of Life,
Satisfaction with the virtual and face-to-face counseling method,
Fasting blood sugar
General information
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Reason for update
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Restriction of words and failure to include a blood sugar test
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190916044783N1
Registration date:
2020-04-19, 1399/01/31
Registration timing:
prospective
Last update:
2021-01-03, 1399/10/14
Update count:
1
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Registration date
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2020-04-19, 1399/01/31
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-10-23, 1398/08/01
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Expected recruitment end date
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2019-12-24, 1398/10/03
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Actual recruitment start date
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2020-04-27, 1399/02/08
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Actual recruitment end date
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2020-06-23, 1399/04/03
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Trial completion date
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2020-09-23, 1399/07/02
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Scientific title
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Effectiveness Comparison of Body- Mind Intervention in Virtual and Face to Face Method on Quality of Life in Polycystic Ovary Syndrome
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Public title
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Effectiveness of Body- Mind Intervention in Virtual and Face to Face Method on Quality of Life in Polycystic Ovary Syndrome
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Married women of childbearing age
Iranian ethnicity
Literacy for reading and writing
Internet literacy and android or i o s mobile phone for both group
Having a pco case based on Rotterdam criteria and being treated at a diabetes clinic
Having a tendency to do FBS test before study and after 8 week
Willingness to participate in the study
Exclusion criteria:
pregnancy
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Age
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From 15 years old to 49 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using computer random number table
The researcher will begin to provide you with a framework for your statistical community, and you can guide yourself to 60 people who are known and invited as an official source. The researcher used to schedule tables for the visible sample of his eyes in the form of tables and fingers or the tip of a pen. Move between different levels or columns using this and employers to request funding. The selected number is actually the personality code of the budget community that is chosen by the sample. Each code, for example, was assigned to members of a virtual counseling group or face-to-face counseling so that you could arrange your samples in each group of 30 people.The final samples were called to a specific location, the purpose and method of work, and the right to freely participate or not to participate in the research were explained to them. Samples that did not wish to attend the sessions were excluded from the study. Then the required number of samples (30 people for each group) was selected. We again divided the members of each group by throwing coins into two groups of fifteen (B and A) so that if the milk procedure was visible, it belonged to group A, and if the line procedure appeared, it would belong to group B.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-04-24, 1398/02/04
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Ethics committee reference number
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IR.SSU.REC.1398.004
Health conditions studied
1
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Description of health condition studied
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polycystic ovarian syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Quality of Life in Patients with Polycystic Ovary Syndrome
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Timepoint
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Evaluation of quality of life in patients with polycystic ovary syndrome before study and after 8 and 12 weeks
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Method of measurement
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Iranian Amini et al. Quality of Life Questionnaire
Secondary outcomes
1
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Description
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Fasting blood sugar
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Timepoint
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At the beginning of the study and after the end of week 8
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Method of measurement
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Glucometer device
Intervention groups
1
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Description
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Intervention group:virtual counseling of body-mind intervention on quality of life in polycystic ovary syndrome . For the virtual consulting team after forming a channel in the WhatsApp Virtual Network Software (Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ) Is done. This study is performed as pre-test, post-test (week 8 and week 12 after intervention). At the beginning of the study, women completed eight weeks, twelve weeks in addition to demographic questions, a questionnaire of Iranian quality of life, as well as acceptance and satisfaction of a counseling approach and method of self-reporting. Reminds people via SMS.Also, fasting blood sugar measurement in the laboratory of Diabetes Polyclinic is measured twice at the beginning of the study and at the end of week 8 in both groups for free.
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Category
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N/A
2
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Description
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control group:face to face counseling of body-mind intervention on quality of life in polycystic ovary syndrome . In-person group sessions (eight two-hour sessions) In-person counseling is provided for two groups of 15 in the Yazd Diabetes Clinic due to lack of facilities and space. This study is a pre-test, post-test(Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ). Thus, women completed in-person counseling at the beginning of the study, completion of week 8, completion of twelve weeks in addition to demographic questions, Iranian quality of life questionnaire, and acceptance and satisfaction of the counseling approach and method of self-reporting and homework assignments. People were reminded daily via SMS.Also, fasting blood sugar measurement in the laboratory of Diabetes Polyclinic is measured twice at the beginning of the study and at the end of week 8 in both groups for free.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Yazd University of Medical Sciences
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Proportion provided by this source
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60
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable