Comparison of accupressure's effect at points k1 and LI4 on hot flashing of menopaused women referred to selective cilinics affiliated to hospitals of shiraz university of medical sciences 2012-2013
The purpose of the study and study design: Comparison of effect two points of accupressure's points on hot flashing of menopause women - random - not blinded- placebo not used. The study population: volunteers 45-55 years and eligible for inclusion - The main criteria for inclusion: age 55-45 years; passing at least a year after the last menstrual; not having the disease, high blood pressure and cardiovascular diseases; flushing severity scores higher than 5 with VAS criteria; not receiving hormonal and non-hormonal drugs complementary medicine. The main exclusion criteria: unwillingness to cooperate; chemotherapy or radiotherapy and the need for taking any medication during the study. Sample: The study population was selected from among 90 eligible and they randomly divided into three groups of 30(k1 - li4 and control). Intervention: acupressure therapy sessions (10 sessions over 5 weeks) In 2 Groups k1 and li4 and control group (not intervention) completed questionnaires: early intervention and after 6 weeks in all three groups. Outcome Study: Comparison of accupressure's effect within two points K1 and LI4 on three variables (intensity, duration and frequency) hot flashing of menopause women.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013062513770N1
Registration date:2013-07-21, 1392/04/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-21, 1392/04/30
Registrant information
Name
fatemeh zeinaly khozany
Name of organization / entity
shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4255
Email address
zeinali@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research office of Shiraz University Of Medical Sciences
Expected recruitment start date
2013-06-20, 1392/03/30
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of accupressure's effect at points k1 and LI4 on hot flashing of menopaused women referred to selective cilinics affiliated to hospitals of shiraz university of medical sciences 2012-2013
Public title
Comparison of effect two points of accupressure's points on hot flashing of menopaused women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: not receiving hormonal and non-hormonal drugs in the last 6 months; did not have cardiovascular disease at 6 months; flushing severity scores higher than 5 with VAS criteria; age 55-45 years old; passing at least one year of amenorrhea; non-smoking; not having hypertension; no abnormal vaginal bleeding; do not use other forms of complementary medicine; lack of diabetic foot ulcers(contraindications pressure on k1 point); not hysterectomy; not thrombophlebitis or not mass near acupressure region; not amputation of limbs.
Exclusion criteria: lack of willingness to cooperate; the need to Chemotherapy or radiation therapy during the study; diagnose any illness and need to take any medication during the study and amputation of limbs.
Age
From 45 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
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 Shiraz University Of Medical Sciences
Street address
Shiraz, Zand Ave, Shiraz University of Medical Science Building
City
SHIRAZ
Postal code
7193613119
Approval date
2013-06-09, 1392/03/19
Ethics committee reference number
CT-92-6555
Health conditions studied
1
Description of health condition studied
hot flash
ICD-10 code
N95.1
ICD-10 code description
Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause
Primary outcomes
1
Description
Severity of hot flushes
Timepoint
Early intervention and after 6 weeks in all three groups.
Method of measurement
Questionnaire and visual analog scale(vas)pain
2
Description
Frequency of hot flash
Timepoint
Early intervention and after 6 weeks in all three groups
Method of measurement
Questionnaire
3
Description
Flushing time
Timepoint
Early intervention and after 6 weeks in all three groups.
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Improve hot flush
Timepoint
After intervention
Method of measurement
Questionnaire and visual analog scale pain
Intervention groups
1
Description
intervention group: Acupressure session for 10 sessions over 5 weeks in group li4
Category
Treatment - Other
2
Description
intervention group: Acupressure session for 10 sessions over 5 weeks in group k1
Category
Treatment - Other
3
Description
control group : :Without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Street address
Namazi square, Shiraz
City
SHiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Hatam
Street address
7th Flat, Central department of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Sاiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery
Full name of responsible person
Azam Jokar
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 1647 4258
Fax
+98 71 1647 4254
Email
Jokarhs@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh College of Nursing And Midwifery
Full name of responsible person
Azam Jokar
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 1647 4258
Fax
+98 71 1647 4254
Email
Jokarhs@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery
Full name of responsible person
Fatemeh Zeinaly
Position
Student, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 1647 4258
Fax
+98 71 1647 4254
Email
f.zeinaly 1309@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)