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Therapeutic effects of low-level laser therapy in reducing obsessive compulsive disorder symptoms in bipolar patient treatment Compared with the control group

Protocol summary

Study aim
Therapeutic effects of LLLT in reducing ocd symptoms compared with the control group
Design
A clinical trial with a control group, 30 patients with OCD and definitive diagnosis of the level of OCD by questionnaire (YBOCS) and the method of randomization is also done as block randomization.
Settings and conduct
This study will be conducted in the psychiatry department of SBMU. One group will be treated with low level laser for 4 weeks and 9 sessions. The control group is also treated with a device with zero intensity in 4 weeks. The patients and I were blinded in the study, and the third person, who is a colleague of the psychologist, acted as an intermediary between the patients based on age, sex, dosage of drugs consumed and equivalent, duration of obsession.The level of education, marital status, duration of disease onset, previous hospitalization rate, type of drug and their equivalent dose are divided in such a way that there is almost a similar sample in the other group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: outpatients under treatment for OCD, over 18 years old without claustrophobia and psychosis with 2 month medication stabilization. Exclusion criteria: unwillingness to cooperate, complications in patients, patients with a history of neurological diseases, pregnancy or acute and chronic physical illness and receive ECT.
Intervention groups
Two homogeneous groups of 30 patients in a treatment group and a control group. The first group will be formed by patients who will receive laser therapy in the first 4 weeks of outpatient visits, and the second group will be selected as a control group similar to the first group.
Main outcome variables
Average score of obsessive thoughts and behaviors Average score of anxiety Obsessive compulsive disorder symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230815059151N1
Registration date: 2023-10-14, 1402/07/22
Registration timing: prospective

Last update: 2023-10-14, 1402/07/22
Update count: 0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
Ali Faghfouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8846 9459
Email address
ali_md07@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of low-level laser therapy in reducing obsessive compulsive disorder symptoms in bipolar patient treatment Compared with the control group
Public title
Investigating the effect of low-level laser in reducing obsessive-compulsive symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing OCD treatment are referred to a psychiatric clinic as outpatients Age above 18 years No claustrophobia Patients should be in drug stabilization for at least 2 months The patient is not psychotic
Exclusion criteria:
Patients with a history of neurological disease such as epilepsy Having other neurological disorders such as parkinsonism Traumatic brain injury Brain stroke pregnancy Acute and chronic physical illness Cases receiving antidepressant treatment or ECT (convulsive therapy with electroshock).
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the researcher are blinded in the study and the third party arranges the samples in two groups in such a way that in terms of age and sex, level of education, marital status, duration of the onset of the disease, the amount of previous hospitalization, the type of drug and the equivalent dose, they are almost identical. There is a similar one in another group. This third party will also place the laser device on the patient's head.
Placebo
Not 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
6th floor,Building No. 2,Shahid Beheshti University of Medical Science,Shahid Arabi,Yemen St,Shahid Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
193954631
Approval date
2023-06-27, 1402/04/06
Ethics committee reference number
Ir.sbmu.msp.rec.1402.155

Health conditions studied

1

Description of health condition studied
Obsessive compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

Primary outcomes

1

Description
OCD severity based on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Timepoint
Measuring the level of obsessive compulsive disorder before the start of treatment and then at the end of treatment and one month after the last treatment in an outpatient visit to a psychiatric clinic.
Method of measurement
Yale-Brown Obsessive Compulsive Scale Questionnaire (Y-BOCS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will be formed by patients who receive laser therapy as an adjuvant treatment in the first four weeks of outpatient visits. This group is treated with low-power laser for 9 sessions over a period of 4 weeks. 24 semi-conductor lasers with a power of 100 mW are used for laser treatment of patients, which are placed on a helmet. 12 of the lasers have a visible wavelength of 630 nm and the other 12 have a wavelength of 810 nm. The laser beam is pulsed with a frequency of 75 Hz and a duty cycle of 20 percent for 10 to 20 minutes to the scalp area of the patients. According to the diameter of the laser beam on the skull surface of the patients, which is 0.21 cm2, the power density and energy density applied to the patients in each session are 0.9 W/cm2 and 56.5 J/cm2, respectively.
Category
Treatment - Other

2

Description
Control group: The control group is treated with a silent laser device with zero intensity in the first 4 weeks of outpatient visits for 9 sessions.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Ali Faghfouri
Street address
Shahid Arabi St., next to Shahid Beheshti University of Medical Science, Shahid Arabi St.,Yemen St,Shahid Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۱۱۵۱
Phone
+98 21 2243 2560
Email
info@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
5th floor,Building No. 2,Shahid Beheshti University of Medical Science,Shahid Arabi,Yemen St,Shahid Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 2243 9872
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Faghfouri
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Unit 4, No 85, Hayamanesh st, Dabestan, seyyed khandan, Tehran, iran
City
Tehran
Province
Tehran
Postal code
1631668115
Phone
+98 21 8846 9459
Fax
Email
ali_md07@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Faghfouri
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Unit 4, No 85, Hayamanesh st, Dabestan, seyyed khandan, Tehran, iran
City
Tehran
Province
Tehran
Postal code
1631668115
Phone
+98 21 8846 9459
Fax
Email
ali_md07@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Faghfouri
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Unit 4, No 85, Hayamanesh st, Dabestan, seyyed khandan, Tehran, iran
City
Tehran
Province
Tehran
Postal code
1631668115
Phone
+98 21 8846 9459
Fax
Email
ali_md07@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Main outcome information and aggregate data can be shared after de-identifying individuals.
When the data will become available and for how long
Immediately after printing the results
To whom data/document is available
All researchers working in academic and scientific institutions and people working in the industry and all those interested
Under which criteria data/document could be used
By observing the ethical principles, it is possible to use the data for future research or other purposes.
From where data/document is obtainable
By phone or e-mail address (Ali_md07@yahoo.com) with the person responsible for the study
What processes are involved for a request to access data/document
Providing explanations for where and how to use data by explaining ethical protocols
Comments
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