The effect of acupressure on quality of life in patients with pcos
Design
Clinical trials with control group, with parallel groups, randomized
Settings and conduct
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
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
Pcos approved by the gynecologist; The lack of any systemic or endocrine and nervous diseases including cardiovascular disease, diabetes type 1 and 2,
. Not taking any hormone other than clomiphene; Marriage; Age of 45;15 years
Earning the minimum score (1/3 score of 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
The lack of male infertility (confirmed by the Spectrum Test;Exit criteria:
Clomiphene's arbitrary interruption; Non-cooperation of research unit to continue treatment; The occurrence of psychological problems such as close relatives during the study, which prevent the completion of the intervention process.
Intervention groups
Group (A): The subject's group of acupressure points with clomiphene
Group( B): Group of Acupuncture Pseudo-Pseudoephedrons with Clomiphene
Main outcome variables
Improving the quality of life of patients with polycystic ovary syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180725040587N1
Registration date:2018-08-29, 1397/06/07
Registration timing:registered_while_recruiting
Last update:2018-08-29, 1397/06/07
Update count:1
Registration date
2018-08-29, 1397/06/07
Registrant information
Name
Marzieh Nekooi Nematollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 7230
Email address
nekooim@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-12, 1397/05/21
Expected recruitment end date
2018-09-12, 1397/06/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on quality of life in patients with polycystic ovarian syndrome
Public title
The effect of acupressure on quality of life in patients with polycystic ovarian syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
By the gynecologist, polycystic ovarian syndrome has been confirmed
Failure to have any systemic or endocrine disruption, including cardiovascular disease, type 1 and type 2 diabetes, neoplastic diseases
No addiction to hookah, cigarettes, drugs and alcohol
Not taking any hormone other than clomiphene
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
The absence of a male factor in male infertility (confirmed by the Spectrum test)
Having ages 45-15 years
Exclusion criteria:
Clomiphon's arbitrary cessation
Uncooperative research unit to continue treatment
The emergence of psychological problems such as near-death during the study, which prevents the intervention from completing
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using software Sample Randomizer
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Yasouj University of Medical Sciences
Street address
Yasuj-Shahid Motahari Blvd.-Yasouj University of Medical Sciences
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2018-07-20, 1397/04/29
Ethics committee reference number
IR.YUMS.REC.1397.035
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 in Patients with Polycystic Ovary Syndrome
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Modified Polycystic Ovary Syndrome Health-Related Quality Of Life Questionnaire (MPCOSQ) ،Short Form12 (SF-12)
Secondary outcomes
1
Description
Hirsutism
Timepoint
Before intervention, three months after the intervention
Method of measurement
Friedman Galway Scale
2
Description
Acne
Timepoint
Before intervention, three months after the intervention
Method of measurement
Global Acne Grading System (GAGS)
3
Description
Alopecia
Timepoint
Before intervention, three months after the intervention
Method of measurement
Ludwig scale
4
Description
Total Testosterone
Timepoint
Before intervention, three months after the intervention
Method of measurement
NG/L
Intervention groups
1
Description
Intervention group: Intervention in Group A (acupressure points) for three months (equivalent to 12 weeks) twice a week, each session for one hour (every 12 minutes including REN-3, REN-4, IV3 L, SP10, (SP6) will begin with an amount of pressure so that the affected spot becomes anesthetized. The location of acupressure points and false points will be determined by the laser pointing machine.
Category
Lifestyle
2
Description
Control group: Intervention in group B (acupressure pseudotropic points) for three months (equivalent to 12 weeks) twice a week, each session for one hour (every 12 minutes including REN-3, REN-4, IV3 L, SP10 , SP6) and will begin with an amount of pressure to the point where the affected spot becomes anesthetized. The location of acupressure points and false points will be determined by the laser point finder
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Women's Specialty Clinic located in the martyr Mohfat Clinic affiliated to Yasouj University of Medi
Full name of responsible person
Dr. Bahram Mohammadi
Street address
Golestan No. 10,60 Metro Street
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 1222 3299
Email
nekooim@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Hossein Marie ouriad
Street address
Yasuj, Blvd. Motahi, Yasouj University of Medical Sciences
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7230
Email
nekooim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Doctor Naza Afrin Hosseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Yasouj University of Medical Sciences،School of Nursing and Midwifery Zeinab Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 3323 5140
Email
hosseinichenar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Nazafarin Hosseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Yasouj University of Medical Sciences،School of Nursing and Midwifery Zeinab Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 3323 5140
Email
hosseinichenar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Marzieh Nokui Nematollahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Yasouj University of Medical Sciences،School of Nursing and Midwifery Zeinab Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 3323 5140
Email
nekooim@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