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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: IRCT
Last refreshed on: 22 February 2018
Main ID:  IRCT2017060634353N1
Date of registration: 2017-06-19
Prospective Registration: Yes
Primary sponsor: Kermanshah University of Medical Sciences / Vice Chancellor for Research and Technology
Public title: The effect of Transcutaneous Electrical Acupoint Stimulation on sleep quality
Scientific title: The effect of Transcutaneous Electrical Acupoint Stimulation on sleep quality in patient with chronic insomnia
Date of first enrolment: 2017-06-22
Target sample size: 40
Recruitment status: Complete
URL:  http://en.irct.ir/trial/26268
Study type:  interventional
Study design:  Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.  
Phase:  N/A
Countries of recruitment
Iran (Islamic Republic of)
Contacts
Name: Behbam Khaledi Paveh   
Address:  Kermanshah University of Medical Sciences, Shahid Beheshti Blvd. Kermanshah Iran (Islamic Republic of)
Telephone: +98 83 3827 9796
Email: bkhaledipaveh@kums.ac.ir
Affiliation:  Kermanshah University of Medical Sciences
Name: Soroush Maazinezhad   
Address:  Kermanshah University of Medical Sciences, Shahid Beheshti Blvd. 6791913481 Kermanshah Iran (Islamic Republic of)
Telephone: +98 83 4612 6767
Email: smedical90@gmail.com
Affiliation:  Kermanshah University of Medical Sciences
Key inclusion & exclusion criteria
Inclusion criteria: Inclusion criteria: no pacemakers in heart; healthy upper and lower limbs. Exclusion criteria: severe psychological trauma during the study and using sleep drugs.
Exclusion criteria:

Age minimum: 18 years
Age maximum: no limit
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic insomnia.
Disorders of initiating and maintaining sleep [insomnias]
Disorders of initiating and maintaining sleep [insomnias]
Intervention(s)
Intervention group: electrical stimulation of acupuncture points on the skin three points H7 and SP6 and L14.
Intervention 1: Control group: only contacts with the same points without electrical stimulation probe. Intervention 2: Intervention group: electrical stimulation of acupuncture points on the skin three points H7 and SP6 and L14.
Treatment - Other
Control group: only contacts with the same points without electrical stimulation probe
Primary Outcome(s)
Sleep quality. Timepoint: Before and one month after intervention. Method of measurement: Using the Pittsburgh Sleep Quality Index and Actigraphy.
Secondary Outcome(s)
The little red-site irritation. Timepoint: After intervention. Method of measurement: Find and physical examination.
Secondary ID(s)
Source(s) of Monetary Support
Kermanshah University of Medical Sciences / Vice Chancellor for Research and Technology
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Kermanshah University of Medical Sciences
Results
Results available:
Date Posted:
Date Completed:
URL:
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