The purpose of this single blind placebo controlled randomized is to investigate the effect of acupressure on the early menopausal complications. Study population are include menopausal women who have hot flash and nigh sweat and anxiety and sleep quality disorders and are referred to selected public health centers in Tehran. the informed consent is obtained from patients. The patients will randomly assign in to intervention and placebo groups (n= 35 each). Intervention group receive ( acupressure wrist band with push- button and education lifestyle changes during menopause) and placebo group receive (acupressure wrist band with out push- button and education lifestyle changes during menopause) for 4 weeks in the specific acupressure points ( include Shenmen,Fuliu,Sanyinjiao) in wirst and ankle. Main out come measures are frequency and severity of hot flash and night sweating and severity of anxiety and sleep quality score wich measure by qustionnaires (Pittsburgh and Spielberger) and diary card for frequency and severity of hot flash and nigh sweat before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112278537N1
Registration date:2012-03-10, 1390/12/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-10, 1390/12/20
Registrant information
Name
Maryam Armand
Name of organization / entity
The International Branch of Shahid Beheshti University of Medical Sciences & Health services
Country
Iran (Islamic Republic of)
Phone
+98 21 4443 1793
Email address
sahar_armand@yahoo.com
Recruitment status
Recruitment complete
Funding source
The International Branch of Shahid Beheshti University of Medical Sciences & Health Services
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2012-06-14, 1391/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupressure on the early menopausal complications in menopausal women who referred to selected health centers in Tehran 2012
Public title
Acupressure and treatment the early menopausal complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Iranian nationality,being literate,age range 45-55 years,post menopausal females (elapsing 12 months of last menstural phase),not using acupressure,reporting at least two times hot flashes per day and having night sweat and anxiety and sleep quality disorders.
Exclusion criteria: women who received hormon therapy during the last 6 months,having any known diseases such as diabetes,cardiovascular diseases,hypertention and thyroid diseases,having any known diseases in hand or foot,consumption of drugs such as sedative,alfa adrenergic agonist such as clonidin,supplements such as soya,vitamin E,cigarette smoking.
Age
From 45 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The International Branch of Shahid Beheshti University of Medical Sciences & Health services
Street address
No 19,next to Shahid Hammat Bridge,vali asr street-Shahid Abaspoorst street,Tehran.
City
Tehran
Postal code
Approval date
2011-10-13, 1390/07/21
Ethics committee reference number
3743/116
Health conditions studied
1
Description of health condition studied
Early menopausal complications
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
The severity and frequency of hot flashes
Timepoint
A week before the study,end of second week,end of fourth week
Method of measurement
Diary card
2
Description
The severity and frequency of night sweat
Timepoint
A week before the study,end of second week,end of fourth week
Method of measurement
Diary card
3
Description
Severity of anxiety
Timepoint
Before the study,end of second week,end of fourth week
Method of measurement
Anxiety inventory spielberger
4
Description
Rating the quality of sleep
Timepoint
Before the study,end of second week,end of fourth week
Method of measurement
Pittsburgh sleep quality inventory
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the study,end of fourth week
Method of measurement
Qality of life questionnaire
2
Description
Comparison of sleep quality score
Timepoint
Before the study,end of fourth week
Method of measurement
Pittsburgh sleep quality score
Intervention groups
1
Description
In the intervention group will be acupressure wrist band with push-button (for use Three times a week for 15 minutes ) and education lifestyle changes during menopause.
Category
Treatment - Other
2
Description
In the control group will be acupressure wrist band with out push-button (for use Three times a week for 15 minutes ) and education lifestyle changes during menopause.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centre Yaftabad
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Health centre Shadabad
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The International Branch of Shahid Beheshti University of Medical Sciences & Health services
Full name of responsible person
Dr. Ghanati, Research Manager
Street address
No 19,next to Shahid Hammat Bridge, vali asr street-Shahid Abaspoorst street,Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The International Branch of Shahid Beheshti University of Medical Sciences & Health services
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
The International Branch of Shahid Beheshti Univercity of Medical Sciences & Health services
Full name of responsible person
Maryam Armand
Position
Midwifery Master student of the International Branch of Shahid Beheshti University of Medical Scienc
Other areas of specialty/work
Street address
No 19,next to Shahid Hammat Bridge,vali asr street-Shahid Abaspoorst street,Tehran.
City
Tehran
Postal code
Phone
00982144431793; 00982188209024
Fax
Email
sahar_armand@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
The International Branch of Shahid Beheshti University of Medical Sciences & Health Services
Full name of responsible person
Giti Ozgoli
Position
Department of Midwifery, Faculty of Nursing-Midwifery Shahid Beheshty University of Medical Sciences
Other areas of specialty/work
Street address
No 19,next to Shahid Hammat Bridge, vali asr street-Shahid Abaspoorst street,Tehran.
City
Tehran
Postal code
Phone
+98 21 8820 9020
Fax
Email
gozgoli@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The International Branch of Shahid Beheshti University of Medical Sciences & Health Services
Full name of responsible person
Maryam Armand
Position
Midwifery Master Student
Other areas of specialty/work
Street address
No 19,next to Shahid Hammat Bridge, vali asr street-Shahid Abaspoorst street,Tehran.
City
Tehran
Postal code
Phone
+98 21 8820 9020
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)