To evaluate the Low Level Laser Therapy (LLLT) impact on cognitive impairment in institutionalized chronic schizophrenia patients
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 32 patients
Settings and conduct
A randomized double-blind clinical trial performed among the schizophrenia patients, in a men’s residential treatment centers, in Razi Psychiatric Hospital, in Tehran, Iran during the year 2020. The medically unstable patients and the ones with active suicidal idea were excluded from this survey. We screened the cognitive impairment by Mini–Mental State Examination (MMSE) and also Positive And Negative Syndrome Scale (PANSS) was used to assess the patients’ positive and negative symptoms
Participants/Inclusion and exclusion criteria
All the medically stable chronic schizophrenic patients between 18-65 years old without active suicidal idea were included in this survey and the ones out of the age range and those who were medically unstable and had suicidal idea were excluded
Intervention groups
The case group will take LLLT therapy and the other group is sham controlled
Main outcome variables
The Low Level Laser Therapy (LLLT) impact on cognitive impairment and schizophrenic symptoms in institutionalized chronic schizophrenia patients will be assessed. The cognitive impairment will be checked by using the Mini–Mental State Examination(MMSE) at the base time and after treatment. The schizophrenia symptoms(positive and negative, etc) will be analyzed by Positive And Negative Syndrome Scale (PANSS) at the base time and after the treatment as well.
General information
Reason for update
Acronym
Low Level Laser Therapy(LLLT)
IRCT registration information
IRCT registration number:IRCT20210520051349N1
Registration date:2021-05-24, 1400/03/03
Registration timing:prospective
Last update:2021-05-24, 1400/03/03
Update count:0
Registration date
2021-05-24, 1400/03/03
Registrant information
Name
Ali Kheradmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2560
Email address
dr.alikheradmand@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Low Level Laser Therapy in Cognitive Function of Chronic Schizophrenia Patients
Public title
The effect of low level laser therapy in cognitive dysfunction and positive and negative symptoms in chronic schizophrenic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
chronic schizophrenic patients
medically stable patients
no active suicidal idea or intention
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Male
Phase
1-2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation software was used to randomized the total 32 cases (according to previous similar studies ). The total 32 being allocated to 16 cases and 16 controls
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, The main researcher, Those who assess the results
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Taleghani Educational Hospital, Tabnak St. Velenjak Region, Chamran High Way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.067
Health conditions studied
1
Description of health condition studied
Chronic Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
To evaluate the Low Level Laser Therapy (LLLT) impact on cognitive impairment in institutionalized chronic schizophrenia patients
Timepoint
No meaningful difference in PANSS and MMSE test score were detected in both groups after the 6th session and 2 months after laser therapy
Method of measurement
To evaluate the LLLT impact on cognitive impairment in institutionalized chronic schizophrenia patients
Secondary outcomes
1
Description
The LLLT effects on positive and negative schizophrenic patients
Timepoint
at the base time and after the 6 th therapy session and finally 2 months after the last session
Method of measurement
PANSS questionnaire
Intervention groups
1
Description
Intervention group:
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi psychiatric hospital
Full name of responsible person
Ali Kheradmand
Street address
Tehran Province, Tehran, Jaddeh-ye-Amin Abad
City
Rey
Province
Tehran
Postal code
1866958891
Phone
+98 21 3340 1220
Email
razi@uswr.ac.ir
Web page address
https://razi.uswr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
کمیته تحقيقات دانشگاه علوم پزشکی شهید بهشتی
Street address
t 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Ira