The comparison of the effect of acupuncture and drug therapy on hot flash and sleep disorders in menopausal women
Design
After obtaining written consent from eligible clients, individuals were randomly assigned based on randomly numbers table to two groups.
Settings and conduct
Acupuncture performed by a physician with acupuncture specialty. In the case group (acupuncture), acupuncture performed three times a week, each session took last for 20 minutes. Intervention duration were 4 weeks. Acupuncture points determined based on traditional Korean medicine, including ST36, SP6, L14, PC6, HT7, HT8, and a point at the bottom of the CV4 abdomen. A total of 7 points selected to reduce hot flashes. Subjects followed for 12 weeks after acupuncture.
In the control group (routine care), fluoxetine administered for 4 weeks and subjects then followed for 12 weeks.
Participants/Inclusion and exclusion criteria
1 - Lack of menstruation at least in the past 12 months
2- Natural menopause
3. No history of ovarian surgery or hysterectomy
4- Lack of diabetes, migraine or receiving medication for any internal disorder
Intervention groups
Menopausal women with hot flash and sleep disorders
Main outcome variables
Evaluation of the frequency of hot flashes during day and night
Evaluation of the severity of hot flashes during day and night
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171104037220N2
Registration date:2020-06-28, 1399/04/08
Registration timing:retrospective
Last update:2020-06-28, 1399/04/08
Update count:0
Registration date
2020-06-28, 1399/04/08
Registrant information
Name
Tahereh Fathi Najafi
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 51 3225 0044
Email address
fathi_midwife@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-01-29, 1392/11/09
Expected recruitment end date
2017-12-31, 1396/10/10
Actual recruitment start date
2014-05-01, 1393/02/11
Actual recruitment end date
2019-12-31, 1398/10/10
Trial completion date
2020-01-21, 1398/11/01
Scientific title
The comparison of the effect of acupuncture and drug therapy on controlling hot flash and sleep disorders in menopause women
Public title
Acupuncture and menopausal disorders control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having adequate literacy to fill out the forms
Lack of menstruation at least in the past 12 months
Natural menopause
Experiencing at least 4 hot flashes during the day
No history of ovarian surgery
Confirmation of menopause with the help of hormonal testing and confirmation of E2<18 pg/ml, FSH = 30-110 IU/L
Lack of thyroid disorders and TSH = 0.4-4/IU/mL
Not using any over-the-counter herbal medicine based on doctor prescription to reduce hot flashes
Lack of diabetes, migraine or receiving medication for any internal disorder
Lack of chronic infections
Exclusion criteria:
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
82
Actual sample size reached:
89
Randomization (investigator's opinion)
Randomized
Randomization description
Menopausal women who referred to the Gynecology Clinic of Imam Reza Hospital due to hot flashes and were eligible to participate in the study based on inclusion and exclusion criteria randomly assigned to intervention and control groups based on random block allocation with a block size of 2. Each block stratified based on the frequency of hot flushed per day (less than 7 times and more than 7 times) and age at menopause (younger than 45
years old and older than 45 years old). Random allocation performed by assigning the first subject based on the frequency of hot flush per day to intervention or control group and assigning it's pair based on frequency of hot flush to the other group. This method ensured the similar allocation number in the study groups. To protect patients' rights, if the subjects did not not like to continue acupuncture, they referred to the normal care.
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
Ethical Committee of the Mashhad University of Medical Sciences
Evaluation of the frequency and severity of hot flashes
Timepoint
Before acupuncture, at the end of acupuncture period (4th week) and 12 weeks after acupuncture in the acupuncture group, before fluoxetine treatment, 4 weeks after treatment initiation and 12 weeks after treatment
Method of measurement
Severity of hot flash and Pittsburgh sleep disorder questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acupuncture performed three times a week, each session took last for 20 minutes. Intervention duration was 4 weeks. Acupuncture points determined based on traditional Korean medicine, including ST36, SP6, L14, PC6, HT7, HT8, and a point at the bottom of the CV4 abdomen. A total of 7 points selected to reduce hot flashes. Metal disposable needles used for the acupuncture in the mentioned points for 20 minutes. The length of the needles were 40 mm. The needles inserted 3-15 mm deep in the mentioned points.
Category
Treatment - Other
2
Description
Control group: Were received fluoxetine for 4 weeks and subjects were then be followed for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Tahereh Fathi Najafi
Street address
Unit 9, No 55, 17 th Honarestan st
City
Mashhad
Province
Razavi Khorasan
Postal code
9178755114
Phone
+98 51 3868 7122
Email
fathi_midwife@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Leyla Porali
Street address
Goreshi biulding, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9179734688
Phone
+98 51 3841 2081
Email
pouralil@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Islamic Azad University
Full name of responsible person
Tahereh Fathi Najafi
Position
Assisstant Professore
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Dr Mohamad Shahinfar University, Sarab Bazarche, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9179734688
Phone
+98 51 3225 0044
Email
fathi_midwife@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Leyla Porali
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gham Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9179734688
Phone
+98 51 3859 1511
Email
pouralil@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tahereh Fathi Najafi
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Sarab Bazarcheh
City
Mashhad
Province
Razavi Khorasan
Postal code
9179734688
Phone
+98 51 3225 0044
Email
fathi_midwife@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not 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
Title and more details about the data/document
The comparison of the effects of acupuncture and drug therapy on controlling the frequency and severity of hot flashes among menopausal women
When the data will become available and for how long
From now to 6 months later
To whom data/document is available
Midwives, Obstetricians and gynecologist and acupuncturists
Under which criteria data/document could be used
Protocol and its results
From where data/document is obtainable
Tahereh fathi Najafi
What processes are involved for a request to access data/document