Objective: the effect of electrical stimulation of acupuncture points on the quality of sleep in patients with chronic insomnia.
Design: randomized single-blind control groups with a sample size of 40 people in two groups of 20 cases and controls.
Inclusion criteria: no pacemakers in heart; healthy upper and lower limbs. Exclusion criteria: severe psychological trauma during the study and using sleep drugs.
Sample size: 40.
Intervention: electrical stimulation of acupuncture points intervening time: 8 sessions a month each session 5 minutes. Primary outcomes: improved sleep quality in patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060634353N1
Registration date:2017-06-19, 1396/03/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-19, 1396/03/29
Registrant information
Name
Soroush Maazinezhad
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 4612 6767
Email address
soroush.maazi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Transcutaneous Electrical Acupoint Stimulation on sleep quality in patient with chronic insomnia
Public title
The effect of Transcutaneous Electrical Acupoint Stimulation on sleep quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: no pacemakers in heart; healthy upper and lower limbs. Exclusion criteria: severe psychological trauma during the study and using sleep drugs.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Postal code
Approval date
2017-05-17, 1396/02/27
Ethics committee reference number
IR.KUMS.REC.1396.81
Health conditions studied
1
Description of health condition studied
Chronic insomnia
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnias]
Primary outcomes
1
Description
sleep quality
Timepoint
Before and one month after intervention
Method of measurement
Using the Pittsburgh Sleep Quality Index and Actigraphy
Secondary outcomes
1
Description
The little red-site irritation
Timepoint
After intervention
Method of measurement
Find and physical examination
Intervention groups
1
Description
Control group: only contacts with the same points without electrical stimulation probe
Category
Treatment - Other
2
Description
Intervention group: electrical stimulation of acupuncture points on the skin three points H7 and SP6 and L14.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sleep Research Center, Kermanshah University of Medical Sciences
Full name of responsible person
Soroush Maazinezhad
Street address
Farabi hospital, Dolat Abad blvd.
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences / Vice Chancellor for Research and Technology
Full name of responsible person
Koorosh Hamzehi
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
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 / Vice Chancellor for Research and Technology
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
Kermanshah University of Medical Sciences
Full name of responsible person
Soroush Maazinezhad
Position
Psychiatric Nursing Graduate Student
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Postal code
6791913481
Phone
+98 83 4612 6767
Fax
Email
smedical90@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Behbam Khaledi Paveh
Position
Master of Science in Psychiatric Nursing
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Postal code
Phone
+98 83 3827 9796
Fax
Email
bkhaledipaveh@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Soroush Maazinezhad
Position
Psychiatric Nursing Graduate Student
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Postal code
6791913481
Phone
+98 83 4612 6767
Fax
Email
smedical90@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)