The effect of acupuncture points stimulation with transcutaneous electrical acupoint stimulation device on sleep quality and menopausal symptoms in postmenopausal women
Study the effect of acupuncture points stimulation with transcutaneous electrical acupoint stimulation device on sleep quality and menopausal symptoms in postmenopausal women
Design
This study is a non-blind clinical trial with a parallel design and a control group. The study population will include all postmenopausal women referring to Sanandaj health center. 39 eligible people will be selected conveniently. Random blocks are used for randomization and participants are assigned to three groups (one intervention group and two controls).
Settings and conduct
This study is a non-blinded clinical trial. In this study, acupuncture will be performed with electrical impulses with a voltage of 3.5 volts, a frequency of 2.5 Hz, and a current of 500 microamperes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: no history of acupuncture; A minimum of one year and a maximum of 4 years have elapsed since the last menstrual period; No use of hormone therapy for the past 6 months; A normal menopause
Exclusion criteria: Very severe menopausal symptoms that affect sleep quality; Severe depressive disorder and anxiety; Drug addiction
Intervention groups
In the intervention group, six bilateral HT7, P6, and LI4 acupuncture points will be performed for four weeks twice a week (eight sessions) for five minutes each time for fifty seconds for each point. In the first control group, six bilateral HT7, P6, and LI4 acupuncture points will be performed for four weeks twice a week (eight sessions) for five minutes each time for fifty seconds for each point, but the device is off. In the second control group, no intervention will be performed
Main outcome variables
Sleep quality, Flushing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N167
Registration date:2021-04-18, 1400/01/29
Registration timing:prospective
Last update:2021-04-18, 1400/01/29
Update count:0
Registration date
2021-04-18, 1400/01/29
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupuncture points stimulation with transcutaneous electrical acupoint stimulation device on sleep quality and menopausal symptoms in postmenopausal women
Public title
The effect of acupuncture points stimulation on sleep quality and menopausal symptoms in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No history of acupuncture;
A minimum of one year and a maximum of 4 years have elapsed since the last menstrual period
No use of hormone therapy for the past 6 months
A normal menopause
Exclusion criteria:
Very severe menopausal symptoms that affect sleep quality
Severe depressive disorder and anxiety
Drug addiction
Age
From 47 years old to 57 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Randomized
Randomization description
The permutation random block is used for randomization. In this way, first, the total sample size and the ratio of sample size in groups are determined. Then, the number of samples will be selected from the table of random numbers of single-digit numbers between 0 and 9. For studies with two groups, the numbers 0-9 are divided into two equal blocks with a probability of assigning an individual to each block is 0.5. Block 4-0 for the first group and block 5-9 for the second treatment can be used. Based on the selected numbers from the table of random numbers and the determination of blocks, it is clear in which group each person who enters the study will be placed.
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
ir.kums.rec.1400.001
Health conditions studied
1
Description of health condition studied
Quality of Sleep
ICD-10 code
G47.9
ICD-10 code description
Sleep Disorder, Unspecified
2
Description of health condition studied
Menopausal symptoms
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Sleep quality
Timepoint
End of the intervention and one month after the end of the intervention
Method of measurement
Based on the Pittsburgh Sleep Quality Questionnaire
2
Description
Flushing
Timepoint
Before and after the intervention (one month later)
Method of measurement
Using the Visual Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, six bilateral HT7, P6 and LI4 acupuncture points will be performed for four weeks twice a week (eight sessions) for five minutes each time for fifty seconds for each point.
Category
Treatment - Other
2
Description
In the first control group, six bilateral HT7, P6 and LI4 acupuncture points will be performed for four weeks twice a week (eight sessions) for five minutes each time for fifty seconds for each point, but the device is off.
Category
Other
3
Description
In the second control group, no intervention will be performed
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sanandaj Health Center
Full name of responsible person
Somayeh Parvandi
Street address
Salahuddin Ayoubi Street, Taleghani Street
City
Sanandaj
Province
Kurdistan
Postal code
6917413142
Phone
+98 87 3226 6531
Email
sheydarpour@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Somayeh Parvandi
Position
Master student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
sheydarpour@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sosan Heydarpour
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
sheydarpour@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Somayeh Parvandi
Position
Master student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
sheydarpour@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available