This study, that was a random single blind clinical trial, was done on 60 people who have referred to the office of the neurologist and according to the DSM-IV criteria, their diagnosis has been determined. The samples were determined according to similar studies and random number distributions. They were placed in 2 groups of 30 people with electromagnetic and control (treatment with Alperazolam) and they were treated for 3 weeks. Using the questionnaire of studying the quality of sleep Pitssburgh(PSQI) also the questionnaire of the study of the severity of the insomnia (ISI) of the patients in 3 periods before the study and immediately after the treatment and 1 month after treatment were evaluated and the results were analyzed statistically.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112128382N1
Registration date:2011-12-28, 1390/10/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-28, 1390/10/07
Registrant information
Name
Farid Gossili
Name of organization / entity
Ardebil university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1771 5737
Email address
farid_gossili@yahoo.com
Recruitment status
Recruitment complete
Funding source
1.Ardebil University Of Medical Sciences
2.Mehr Physiotherapy Clinic Of Ardebil
Expected recruitment start date
2007-09-23, 1386/07/01
Expected recruitment end date
2008-09-22, 1387/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized-controlled trial on Electromagnetictherapy for treatment of insomnia
Public title
Electromagnetictherapy for treatment of insomnia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1.According to the DSM-IV criteria, their diagnosis has been determined
2. Their insomnia has lasted for 3 weeks
3.The patient didn't have other problems such as PUD,COPD,IHD,CHF,CVA,Asthmaand etc
Exclusion criteria:
1.Happening side effects
2.Not appropriate participation of patients
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ardebil university of medical sciences
Street address
Daneshgah boulevard
City
Ardebil
Postal code
Approval date
2009-07-09, 1388/04/18
Ethics committee reference number
8801/5
Health conditions studied
1
Description of health condition studied
primary insomnia
ICD-10 code
F51.0
ICD-10 code description
A condition of unsatisfactory quantity and/or quality of sleep, which persists for a considerable period of time, including difficulty falling asleep, difficulty staying asleep, or early final wakening. Insomnia is a common symptom of many mental and phys
Primary outcomes
1
Description
Insomnia
Timepoint
The patients in 3 periods before the study and immediately after the treatment and 1 month after treatment were evaluated
Method of measurement
The questionnaire Pitssburgh Sleep Quality Index(PSQI) also the questionnaire Insomnia Severity Index (ISI)
Secondary outcomes
empty
Intervention groups
1
Description
In the treatment group, patients treated with electromagnetic therapy and 3 weeks for 6 sessions, each session 20 minutes with a frequency of 10 Hz and 35%, with trans-cranial electromagnetic therapy were PMT Quattro.
Category
Treatment - Devices
2
Description
Alprazolam 1 mg tablet daily in the control group patients were treated for 3 weeks,Controls to prevent patients from the placebo effect of the electromagnetic device therapy for 6 sessions in 3 weeks, but no waves were electromagnetic therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatrists in private practice in Ardebil
Full name of responsible person
Dr Parviz Molavi
Street address
City
ardebil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardebil University Of Medical Sciences
Full name of responsible person
Rasool Lotfollahzadeh
Street address
Daneshgah Boulevard
City
Ardebil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardebil University Of Medical Sciences
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
Ardebil University Of Medical Sciences
Full name of responsible person
Farid Gossili
Position
General Practitioner
Other areas of specialty/work
Street address
#2,shahid athari alley,Basij Squre
City
Ardebil
Postal code
Phone
+98 45 1771 5737
Fax
Email
farid_gossili@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardebil University Of Medical Sciences
Full name of responsible person
Parviz Molavi
Position
Specialty psychiatric disorders in children
Other areas of specialty/work
Street address
Fatemi Hospital,Ardebil University Of Medical Sciences
City
Ardebil
Postal code
Phone
+98 45 1223 2520
Fax
Email
FATEMi@ARUMS.AC.IR
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)