Protocol summary
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Study aim
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The effect of acupressure on quality of life in patients with pcos
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Design
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Clinical trials with control group, with parallel groups, randomized
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Settings and conduct
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Study Type: Clinical Trial
Sample number: 96 people
Sample collection site: Women's specialized gynecology clinic located in Yasuj Mofattah Clinic
Data gathering tool: Clinical signs checklist, Laboratory biomarkers and correctional version of the quality of life questionnaire related to health of polycystic ovary syndrome, 12 questions of quality of life questionnaire
Mode of intervention: Split the samples into acupressure group and acupressure pseudo group
Data Measurement: Before intervention, three months after intervention
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Participants/Inclusion and exclusion criteria
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Inclusion criteria
Confirmation of pcos by gynecologist; Marriage; Age 45 to 15 years; Achieving minimum score (1/3 score of quality of life correction questionnaire related to polycystic ovary syndrome), Quality of life questionnaire 12 questions, minimum score 12 to 24; Absence of male infertility (confirmed by spermogram test);
Exclusion criteria: Suffering from any systemic or endocrine and neurological diseases, including: cardiovascular disease, type 1 and 2 diabetes, use of any hormonal drug except clomiphene, hookah and alcohol and smoking addiction according to the research unit, no infertility Male (confirmed by spermogram test)
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Intervention groups
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Group (A): The subject's group of acupressure points with clomiphene
Group( B): Group of Acupuncture Pseudo-Pseudoephedrons with Clomiphene
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Main outcome variables
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Improving the quality of life of patients with polycystic ovary syndrome
General information
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Reason for update
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Applying the opinions of respected professors and judges after the intervention and the defense session
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180725040587N1
Registration date:
2018-08-29, 1397/06/07
Registration timing:
registered_while_recruiting
Last update:
2021-11-01, 1400/08/10
Update count:
1
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Registration date
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2018-08-29, 1397/06/07
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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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2018-08-12, 1397/05/21
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Expected recruitment end date
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2018-09-12, 1397/06/21
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Actual recruitment start date
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2018-08-12, 1397/05/21
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Actual recruitment end date
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2018-10-13, 1397/07/21
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Trial completion date
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2018-10-13, 1397/07/21
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Scientific title
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The effect of acupressure on quality of life in patients with polycystic ovarian syndrome
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Public title
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The effect of acupressure on quality of life in patients with polycystic ovarian syndrome
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
By the gynecologist, polycystic ovarian syndrome has been confirmed
Marital status
Earning the minimum basic score (1.3 points for the correction version of the quality of life questionnaire related to health of polycystic ovary syndrome), Quality of life questionnaire 12 questions, minimum score 24-12
Absence of male infertility (confirmed by spermogram test)
Having ages 45-15 years
Exclusion criteria:
Having any systemic or endocrine and neurological disease based on the patient's question including: cardiovascular disease, type 1 and type 2 diabetes, neoplastic diseases including Cushing's syndrome, congenital adrenal hyperplasia and hyperprolactinemia (approved by a specialist)
Addiction to hookah, cigarettes, drugs and alcohol according to the research unit
Taking any hormonal medication except clomiphene
Presence of male infertility (confirmed by spermogram test)
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Age
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From 15 years old to 45 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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- Participant
- Data analyser
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Sample size
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Target sample size:
96
Actual sample size reached:
96
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization using software Sample Randomizer
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The study will be blind-doubled. In this way, patients will be blinded according to the type of intervention. Patients participating in the study will not know whether the pressure points are real acupressure points or false points. Also statistical analyst about the data of the intervention group (real points of acupressure) and the control group (false points of acupressure)
Will not know.
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Placebo
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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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2018-07-20, 1397/04/29
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Ethics committee reference number
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IR.YUMS.REC.1397.035
Health conditions studied
1
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Description of health condition studied
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Polycystic ovary 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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Before the intervention, three months after the intervention
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Method of measurement
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Modified Polycystic Ovary Syndrome Health-Related Quality Of Life Questionnaire (MPCOSQ) ،Short Form12 (SF-12)
Secondary outcomes
1
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Description
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Hirsutism
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Timepoint
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Before intervention, three months after the intervention
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Method of measurement
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Friedman Galway Scale
2
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Description
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Acne
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Timepoint
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Before intervention, three months after the intervention
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Method of measurement
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Global Acne Grading System (GAGS)
3
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Description
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Alopecia
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Timepoint
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Before intervention, three months after the intervention
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Method of measurement
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Ludwig scale
4
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Description
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Total Testosterone
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Timepoint
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Before intervention, three months after the intervention
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Method of measurement
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NG/L
Intervention groups
1
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Description
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Intervention group: Intervention in group A (real points of acupressure) for a month and a half (equivalent to 12 sessions) twice a week, each session for one hour (each point 5 minutes including points REN-3, REN-4, IV3 L, SP10, (SP6) and will start with the amount of pressure to the extent that the pressure point is anesthetized. The location of acupressure points and false points will be determined by a laser point detector.
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Category
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Lifestyle
2
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Description
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Control group: intervention in group B (false points of acupressure), for a month and a half (equivalent to 12 sessions) twice a week, each session for one hour (each point 5 minutes including points REN-3, REN-4, IV3 L, SP10, SP6) and will start with the amount of pressure to the extent that the pressure point is anesthetized. The location of acupressure points and false points will be determined by a laser point detector
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Category
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Lifestyle
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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Yasouj University of Medical Sciences
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Proportion provided by this source
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100
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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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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available