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effect of laser therapy in reducing of cognitive symptoms, anxiety and depression in patients with mild and moderate dementia

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History
# Registration date Revision Id
2 2023-09-26, 1402/07/04 280351
1 2022-12-12, 1401/09/21 248768
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  • Protocol summary

    Therapeutic effects of low-level laser therapy (LLLT) in reducing symptoms of depression and anxiety in bipolar patients
    Therapeutic effects of low-level laser therapy in reducing of cognitive symptoms, anxiety and depression in patients with mild and moderate dementia
    بررسی اثرات درمانی لیزر کم توان در کاهش علایم افسردگی واضطراب بیماران دوقطبی
    بررسی اثرات درمانی لیزر کم توان در کاهش علایم شناختی افسردگی واضطراب بیماران مبتلا به دمانس خفیف و متوسط
    A clinical trial with a control group with two-way randomized parallel groups on 40 patients. Block randomization is used for randomization.
    A clinical trial with a control group with two-way randomized parallel groups on 24 patients. Block randomization is used for randomization.
    کارازمایی بالینی دارای گروه کنترل با گروهای موازی دوسویه کور تصادفی شده بر روی 40 بیمار.برای تصادفی سازی از بلوک رندومیزیشن استفاده میشود.
    کارازمایی بالینی دارای گروه کنترل با گروهای موازی دوسویه کور تصادفی شده بر روی 24بیمار.برای تصادفی سازی از بلوک رندومیزیشن استفاده میشود.
    The patients referred to the psychiatry department of Taleghani Hospital will be included in the study after obtaining the consent form from both the patient and the family. The psychologist (non-blind) will take their information based on age, gender, level of education, marital status, previous hospitalization, and duration of the disease, the relevant questionnaires note the presentation of symptoms and the level of depression. They are homogeneously divided into two treatment and control groups. Finally, the information obtained from the questionnaires is given to the researcher (blind) to be analyzed.
    In the Memory Clinic of Taleghani Hospital, patients will enter the study after obtaining consent from both the patient and the family, and the psychologist (non-blind) will collect their information based on age, gender, level of education, marital status, and the duration of the onset of the disease, presenting symptoms and the level of depression and anxiety through a questionnaire. He takes notes and divides them homogenously into two treatment and control groups and finally gives the information obtained from the questionnaires to the (blind) researcher to be analyzed.
    دربخش روانپزشکی بيمارستان طالقانی بیماران پس از اخذ رضايت نامه هم از خود بیماروهم از خانواده وارد مطالعه خواهند شدوروانشناس (غیرکور)اطلاعات انهارا بر اساس سن، جنس، ,میزان تحصیلات, وضعیت تاهل ,میزان بستری قبلی ومدت زمان شروع بیماری ,ارائه علائم و ميزان افسردگي توسط پرسشنامه هاي مربوطه يادداشت مي کندو انهارا بطور همگن به دوگروه درمانی و کنترل تقسیم کرده ونهایتا اطلاعات بدست امده از پرسشنامه ها را به محقق(کور) داده تا تحت انالیز قرار بگیرند.
    درکلینیک حافظه بيمارستان طالقانی بیماران پس از اخذ رضايت نامه هم از خود بیماروهم از خانواده وارد مطالعه خواهند شدوروانشناس (غیرکور)اطلاعات انهارا بر اساس سن، جنس، ,میزان تحصیلات, وضعیت تاهل ومدت زمان شروع بیماری ,ارائه علائم و ميزان افسردگي واضطراب توسط پرسشنامه هاي مربوطه يادداشت مي کندو انهارا بطور همگن به دوگروه درمانی و کنترل تقسیم کرده ونهایتا اطلاعات بدست امده از پرسشنامه ها را به محقق(کور) داده تا تحت انالیز قرار بگیرند.
    Inclusion criteria: Patients under the treatment of bipolar depression admitted to the psychiatric ward, aged over 18 years. Exclusion criteria: patients with a history of neurological disease, pregnancy, or acute and chronic physical illness; those receiving antidepressant treatment ECT.
    Inclusion criteria: Dementia patients aged 65 years or older who have been diagnosed with dementia for at least 2 years and are under treatment. exclusion criteria: patients with other major psychiatric disorders, history of severe head trauma, claustrophobia, drug use, benzodiazepines use, and those who have significant changes in symptoms and medication regimen in the last 6 months.
    معیارهای ورود: بيماران تحت درمان افسردگی بای پولار بستری در بخش روانپزشکی با سن بالای 18 سال. معیارهای خروج: بیماران با سابقه بيماري عصبي، بارداري يا بيماري حاد و مزمن جسمي ومواردی که درمان ضدافسردگی یا تشنج درمانی با الکتروشوک دریافت میکنند.
    معیارهای ورود: بیماران مبتلا به دمانس دارای سن 65 سال به بالا که حداقل 2 سال مبتلا به زوال عقل تشخیص داده شده و تحت درمان باشند. ورود به معیار های خروج: بیماران مبتلا به سایر اختلالات عمده روانپزشکی، سابقه ضربه شدید به سر، کلاستروفوبیا، مصرف مواد ومصرف بنزودیازپین وافرادی که در 6 ماه گذشته تغییرات قابل توجهی در علائم و رژیم دارویی داشته باشند
    The therapeutic intervention group underwent laser therapy as an auxiliary treatment in the first two weeks of hospitalization every week. They have 5 sessions . the control group will be treated with a zero-intensity device in the first two weeks of hospitalization. The level of depression and anxiety is evaluated again by a questionnaire at the end of the treatment and one month after the last treatment at the clinic and the before and after results are compared between the 2 groups.
    The group is treated with low power laser for 2 weeks and 3 sessions of 20 minutes each week, the control group has the device on their head but it is turned off. The level of anxiety and depression and cognitive symptoms in the first and sixth session and one month later are compared between the groups using the evaluation questionnaire and the results before and after.
    گروه مداخله درمانی تحت درمان لیزرتراپی به عنوان درمان كمكي در دوهفته اول بستری هرهفته 5جلسه قرارمی گیرند. افراد گروه کنترل نیزتحت درمان با دستگاه با شدت صفردر دوهفته اول بستری قرار می گیرند. سطح افسردگي و اضطراب دوباره توسط پرسشنامه در اخر درمان و يك ماه بعد از آخرين درمان درمراجعه به درمانگاه ارزيابي و نتايج قبل و بعد بين 2 گروه مقايسه مي شود.
    گروه تحت درمان با لیزر کم توان مدت 2 هفته و هر هفته 3 جلسه 20 دقیقه ای قرار می گیرند، گروه کنترل دستگاه روی سرشان است ولی خاموش است. سطح اضطراب و افسردگی وعلائم شناختی در جلسه اول و ششم و یکماه بعد توسط پرسشنامه ارزیابی و نتایج قبل و بعد بین گروه ها مقایسه می شود.
    Anxiety, depression (Hamilton's questionnaire)
    Anxiety(Hamilton's questionnaire); depression (GDS questionnaire);Cognitive symptom(MMSE questionnaire)
    اضطراب، افسردگی (پرسشنامه همیلتون)
    اضطراب(پرسشنامه همیلتون); افسردگی (پرسشنامه GDS);علایم شناختی(پرسشنامه MMSE)

  • General information

    18
    65
    65
    empty
    Year
    empty
    No
    Yes
    40
    24
    2023-11-22, 1402/09/01
    2024-03-18, 1402/12/28
    empty
    lack of patient
    empty
    کمبود بیمار
    Therapeutic effects of low-level laser therapy in reducing Depression and Anxiety symptoms in bipolar patient treatment Compared with the control group
    Therapeutic effects of low-level laser therapy in reducing of cognitive symptoms, anxiety and depression in patients with mild and moderate dementia Compared with the control group
    اثرات درمانی لیزر کم توان در کاهش علایم افسردگی واضطراب بیماران دوقطبی درمقایسه باگروه کنترل
    اثرات درمانی لیزر کم توان در کاهش علایم شناختی افسردگی واضطراب بیماران مبتلا به دمانس خفیف ومتوسط درمقایسه باگروه کنترل
    Therapeutic effects of low-level laser therapy in reducing Depression and Anxiety symptoms in bipolar patient treatment
    effect of laser therapy in reducing of cognitive symptoms, anxiety and depression in patients with mild and moderate dementia
    اثرات درمانی لیزر کم توان در کاهش علایم افسردگی واضطراب بیماران دوقطبی
    اثر لیزر درمانی در کاهش علائم شناختی ، اضطراب و افسردگی در بیماران مبتلا به دمانس خفیف و متوسط
    Patients treated for bipolar depression admitted to the psychiatric ward.
    Age over 18 years.
    Both genders
    Patients with with mild and moderate dementia who have been diagnosed for at least two years
    Age over 65 years.
    Both genders
    بيماران تحت درمان افسردگی بای پولار بستری در بخش روانپزشکی.
    سن بالای 18 سال .
    هر دو جنس
    بيماران مبتلا به دمانس خفیف و متوسط که حداقل دوسال از تشخیص انها گذشته باشد
    سن بالای 65
    هر دو جنس
    Patients with a history of neurological diseases such as epilepsy and other neurological disorders such as parkinsonism, traumatic brain injury, stroke
    pregnancy
    Acute and chronic physical illness
    Cases receiving antidepressant treatment or ECT (convulsive therapy with electroshock).
    Patients with a history of major psychatric disorder clastrophobia
    substance use
    benzodiazepin use
    People who have significant changes in symptoms and drug regimen in the last 6 months
    history of sever traumatic brain injury
    بیماران با سابقه بيماري عصبي به عنوان مثال صرع و ساير اختلالات نورولوژيك مثل پاركينسونيسم، آسيب مغزي ضربه اي، سكته مغزي
    بارداری
    بيماري حاد و مزمن جسمي
    مواردی که درمان ضدافسردگی یا ECT (تشنج درمانی با الکتروشوک) دریافت میکنند.
    بیماران مبتلا به سایر اختلالات عمده روانپزشکی،کلاستروفوبیا
    مصرف مواد
    مصرف بنزودیازپین
    افرادی که در 6 ماه گذشته تغییرات قابل توجهی در علائم و رژیم دارویی داشته باشند
    سابقه ضربه به سر شدید
    The method of randomization is done as block randomization for 40 people. If A is for treatment and B is for control, first we define 6 combinations with equal allocation as follows: 1=(ABBA) 2=(ABAB) 3=(AABB) 4=(BABA) 5=(BBAA) 6=(BAAB) Then, using the table of random numbers from 1 to 6, ten numbers are selected and based on the numbers selected from the list above, we determine the order of the patient or the control.
    The method of randomization is done as block randomization for 24 people. If A is for treatment and B is for control, first we define 6 combinations with equal allocation as follows: 1=(ABBA) 2=(ABAB) 3=(AABB) 4=(BABA) 5=(BBAA) 6=(BAAB) Then, using the table of random numbers from 1 to 6, six numbers are selected and based on the numbers selected from the list above, we determine the order of the patient or the control.
    نحوه تصادفی کردن بصورت بلوک رندومیزیشن برای 40 نفر انجام میشود. اگر Aبرای درمان وBبرای کنترل باشد ابتدا 6ترکیب با تخصیص برابر به صورت زیر تعریف میکنیم: 1=(ABBA) 2=(ABAB) 3=(AABB) 4=(BABA) 5=(BBAA) 6=(BAAB) سپس بااستفاده ازجدول اعدادتصادفی از1تا6 ده عدد انتخاب وبراساس شماره های انتخاب شده از لیست بالا ترتیب بیمار یا کنترل را مشخص میکنیم.
    نحوه تصادفی کردن بصورت بلوک رندومیزیشن برای 24 نفر انجام میشود. اگر Aبرای درمان وBبرای کنترل باشد ابتدا 6ترکیب با تخصیص برابر به صورت زیر تعریف میکنیم: 1=(ABBA) 2=(ABAB) 3=(AABB) 4=(BABA) 5=(BBAA) 6=(BAAB) سپس بااستفاده ازجدول اعدادتصادفی از1تا6 شش عدد انتخاب وبراساس شماره های انتخاب شده از لیست بالا ترتیب بیمار یا کنترل را مشخص میکنیم.

  • Health conditions studied

    #1
    F31.4
    F03
    Bipolar disorder, current episode depressed, severe, without psychotic features
    Unspecified dementia
    bipolar disorder
    Dementia
    اختلال دوقطبی
    دمانس

  • Primary outcomes

    #1
    HAMILTON depression questionnaire
    Geriatric depression Scale questionnaire
    پرسشنامه افسردگی همیلتون
    پرسشنامه افسردگی سالمندان GDS
    #2
    empty
    Cognitive symptom
    empty
    علایم شناختی
    empty
    Before and after treatment
    empty
    قبل و بعداز درمان
    empty
    minimal mantal status examination
    empty
    پرسشنامه کوتاه وضعیت ذهنی(MMSE)

  • Intervention groups

    #1
    Intervention group:This group will be formed by patients who receive PBM (photobiomudulation) as an auxiliary treatment in the first two weeks of hospitalization, and their information is based on age, sex, level of education, marital status, previous hospitalization and the duration of the onset of the disease. The symptoms and level of depression are noted by the relevant questionnaires and they are treated with low power laser for 2 weeks and 5 sessions every week. The level of depression and anxiety is again measured by the questionnaire at the end of the treatment and one month after the last treatment at the evaluation clinic and the before and after results are compared between the 2 groups. They receive antipsychotic drugs, they enter the treatment cycle and their dosage is determined.
    Intervention group: This group will be formed by patients who receive PBM (photobiomudulation) as an auxiliary treatment for two weeks and their information is based on age, sex, level of education, marital status and duration of disease onset, cognitive symptoms and depression and anxiety level are noted by the relevant questionnaires and they are treated with low power laser for 2 weeks and 3 sessions every week. The level of depression, anxiety and cognitive symptoms are evaluated again by questionnaire at the end of the treatment and one month after the last treatment when visiting the clinic and the before and after results are compared between the 2 groups.
    گروه مداخله:این گروه توسط بيماراني تشكيل خواهد شد كه PBM(photobiomudulation) را به عنوان درمان كمكي در دوهفته اول بستری دريافت مي كنند و اطلاعات ايشان بر اساس سن، جنس، ,میزان تحصیلات, وضعیت تاهل ,میزان بستری قبلی ومدت زمان شروع بیماری ,ارائه علائم و ميزان افسردگي توسط پرسشنامه هاي مربوطه يادداشت مي شودو تحت درمان با ليزر كم توان مدت 2 هفته و هر هفته 5 جلسه قرار مي گيرند. سطح افسردگي و اضطراب دوباره توسط پرسشنامه در اخر درمان و يك ماه بعد از آخرين درمان درمراجعه به درمانگاه ارزيابي و نتايج قبل و بعد بين 2 گروه مقايسه مي شود.یکسان سازی درمان دارویی نیز به این شکل انجام میشود که بیمارانی که فقط داروهای تثبیت کننده خلق وانتی سایکوتیک دریافت میکنند وارد سیکل درمان میشوند ودوزمعادل آنها تعیین میشود.
    گروه مداخله:این گروه توسط بيماراني تشكيل خواهد شد كه PBM(photobiomudulation) را به عنوان درمان كمكي طی دوهفته دريافت مي كنند و اطلاعات ايشان بر اساس سن، جنس، ,میزان تحصیلات, وضعیت تاهل ومدت زمان شروع بیماری , علائم شناختی و ميزان افسردگي و اضطراب توسط پرسشنامه هاي مربوطه يادداشت مي شودو تحت درمان با ليزر كم توان مدت 2 هفته و هر هفته 3جلسه قرار مي گيرند. سطح افسردگي و اضطراب وعلایم شناختی دوباره توسط پرسشنامه در اخر درمان و يك ماه بعد از آخرين درمان درمراجعه به درمانگاه ارزيابي و نتايج قبل و بعد بين 2 گروه مقايسه مي شود.
    #2
    Control group:The people of the second group will be selected as the same control group as the first group. The level of depression and anxiety is again measured by the questionnaire at the end of the treatment and one month after the last treatment at the evaluation clinic and the before and after results are compared between the 2 groups. They receive antipsychotics, they enter the treatment cycle, and their equivalent dose is determined, and a person with the same amount of medicine is placed in the control group.
    Control group: The people of the second group will be selected as the same control group as the first group. Cognitive symptoms, level of depression and anxiety are evaluated by a questionnaire at the beginning of the treatment, at the last session of the treatment and one month after the last treatment at the clinic and the before and after results are compared between the 2 groups.
    گروه کنترل: افراد گروه دوم برهمان اساس به عنوان گروه كنترل همسان با گروه اول انتخاب خواهند شد.گروه کنترل نیز تحت درمان با دستگاه با شدت صفردر دوهفته اول بستری قرار می گیرند. سطح افسردگي و اضطراب دوباره توسط پرسشنامه در اخر درمان و يك ماه بعد از آخرين درمان درمراجعه به درمانگاه ارزيابي و نتايج قبل و بعد بين 2 گروه مقايسه مي شود.یکسان سازی درمان دارویی نیز به این شکل انجام میشود که بیمارانی که فقط داروهای تثبیت کننده خلق وانتی سایکوتیک دریافت میکنند وارد سیکل درمان میشوند ودوزمعادل آنها تعیین میشود ودرگروه کنترل نیزفردی با همین مقداردارو قرار میگیرد.
    گروه کنترل: افراد گروه دوم به عنوان گروه كنترل همسان با گروه اول انتخاب خواهند شد.گروه کنترل نیز تحت درمان با دستگاه با شدت صفرطی دوهفته قرار می گیرند. علایم شناختی ,سطح افسردگي و اضطراب توسط پرسشنامه در ابتدای درمان ,جلسه اخر درمان و يك ماه بعد از آخرين درمان درمراجعه به درمانگاه ارزيابي و نتايج قبل و بعد بين 2 گروه مقايسه مي شود.

  • Recruitment centers

    #1
    Name of recruitment center - English: Taleghani Hospital
    Name of recruitment center - Persian: بیمارستان طالقانی
    Full name of responsible person - English: علی خردمند
    Full name of responsible person - Persian: Ali KHeradmand
    Street address - English: Taleghani Hospital,kodakyar Street , Student Blvd ,Valenjak
    Street address - Persian: ولنجک ،بلوار دانشجو،خیابان کودکیار،بیمارستان طالقانی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985711151
    Phone: +98 21 2243 2560
    Fax: +98 21 2243 2570
    Email: taleghanihospital@sbmu.ac.ir
    Web page address: http://taleghani.sbmu.ac.ir
    Name of recruitment center - English: Taleghani Hospital
    Name of recruitment center - Persian: بیمارستان طالقانی
    Full name of responsible person - English: Ali Kheradmand
    Full name of responsible person - Persian: علی خردمند
    Street address - English: Taleghani Hospital,kodakyar Street , Student Blvd ,Valenjak
    Street address - Persian: ولنجک ،بلوار دانشجو،خیابان کودکیار،بیمارستان طالقانی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985711151
    Phone: +98 21 2243 2560
    Fax: +98 21 2243 2570
    Email: taleghanihospital@sbmu.ac.ir
    Web page address: http://taleghani.sbmu.ac.ir

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: افشین زرقی
    Full name of responsible person - Persian: Afshin zarghi
    Street address - English: Student Blvd ,Valenjak
    Street address - Persian: ولنجک ،بلوار دانشجو
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1983969411
    Phone: +98 21 2243 9770
    Fax:
    Email: info@sbmu.ac.ir
    Web page address: https://old.sbmu.ac.ir

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Afshin Zarghi
    Full name of responsible person - Persian: افشین زرقی
    Street address - English: Student Blvd ,Valenjak
    Street address - Persian: ولنجک ،بلوار دانشجو
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1983969411
    Phone: +98 21 2243 9770
    Fax:
    Email: info@sbmu.ac.ir
    Web page address: https://old.sbmu.ac.ir

Protocol summary

Study aim
Therapeutic effects of low-level laser therapy in reducing of cognitive symptoms, anxiety and depression in patients with mild and moderate dementia
Design
A clinical trial with a control group with two-way randomized parallel groups on 24 patients. Block randomization is used for randomization.
Settings and conduct
In the Memory Clinic of Taleghani Hospital, patients will enter the study after obtaining consent from both the patient and the family, and the psychologist (non-blind) will collect their information based on age, gender, level of education, marital status, and the duration of the onset of the disease, presenting symptoms and the level of depression and anxiety through a questionnaire. He takes notes and divides them homogenously into two treatment and control groups and finally gives the information obtained from the questionnaires to the (blind) researcher to be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Dementia patients aged 65 years or older who have been diagnosed with dementia for at least 2 years and are under treatment. exclusion criteria: patients with other major psychiatric disorders, history of severe head trauma, claustrophobia, drug use, benzodiazepines use, and those who have significant changes in symptoms and medication regimen in the last 6 months.
Intervention groups
The group is treated with low power laser for 2 weeks and 3 sessions of 20 minutes each week, the control group has the device on their head but it is turned off. The level of anxiety and depression and cognitive symptoms in the first and sixth session and one month later are compared between the groups using the evaluation questionnaire and the results before and after.
Main outcome variables
Anxiety(Hamilton's questionnaire); depression (GDS questionnaire);Cognitive symptom(MMSE questionnaire)

General information

Reason for update
lack of patient
Acronym
IRCT registration information
IRCT registration number: IRCT20220614055175N1
Registration date: 2022-12-12, 1401/09/21
Registration timing: registered_while_recruiting

Last update: 2023-09-30, 1402/07/08
Update count: 1
Registration date
2022-12-12, 1401/09/21
Registrant information
Name
Somayeh Jarrahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 7176
Email address
jarrahi1364@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of laser therapy in reducing of cognitive symptoms, anxiety and depression in patients with mild and moderate dementia
Public title
Therapeutic effects of low-level laser therapy in reducing of cognitive symptoms, anxiety and depression in patients with mild and moderate dementia Compared with the control group
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with with mild and moderate dementia who have been diagnosed for at least two years Age over 65 years. Both genders
Exclusion criteria:
Patients with a history of major psychatric disorder clastrophobia substance use benzodiazepin use People who have significant changes in symptoms and drug regimen in the last 6 months history of sever traumatic brain injury
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is done as block randomization for 24 people. If A is for treatment and B is for control, first we define 6 combinations with equal allocation as follows: 1=(ABBA) 2=(ABAB) 3=(AABB) 4=(BABA) 5=(BBAA) 6=(BAAB) Then, using the table of random numbers from 1 to 6, six numbers are selected and based on the numbers selected from the list above, we determine the order of the patient or the control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each patient is assigned a code at the beginning of the study, which will be known by that code until the end of the study. This study was conducted in a double-blind manner, so that the patients, doctors, and clinical caregivers and the data analyzer are not aware of the groupings and only the third party, who is the psychologist of the department It will group people and evaluate relevant questionnaires before and after treatment.
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 Hospital,kodakyar Street , Student Blvd ,Valenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2022-10-23, 1401/08/01
Ethics committee reference number
IR.SBMU.MSP.REC.1401.349

Health conditions studied

1

Description of health condition studied
Dementia
ICD-10 code
F03
ICD-10 code description
Unspecified dementia

Primary outcomes

1

Description
Depression
Timepoint
Before and after treatment
Method of measurement
Geriatric depression Scale questionnaire

2

Description
Anxiety
Timepoint
Before and after treatment
Method of measurement
Hamilton anxiety questionnaire

3

Description
Cognitive symptom
Timepoint
Before and after treatment
Method of measurement
minimal mantal status examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group will be formed by patients who receive PBM (photobiomudulation) as an auxiliary treatment for two weeks and their information is based on age, sex, level of education, marital status and duration of disease onset, cognitive symptoms and depression and anxiety level are noted by the relevant questionnaires and they are treated with low power laser for 2 weeks and 3 sessions every week. The level of depression, anxiety and cognitive symptoms are evaluated again by questionnaire at the end of the treatment and one month after the last treatment when visiting the clinic and the before and after results are compared between the 2 groups.
Category
Treatment - Devices

2

Description
Control group: The people of the second group will be selected as the same control group as the first group. Cognitive symptoms, level of depression and anxiety are evaluated by a questionnaire at the beginning of the treatment, at the last session of the treatment and one month after the last treatment at the clinic and the before and after results are compared between the 2 groups.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Ali Kheradmand
Street address
Taleghani Hospital,kodakyar Street , Student Blvd ,Valenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
taleghanihospital@sbmu.ac.ir
Web page address
http://taleghani.sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Student Blvd ,Valenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9770
Email
info@sbmu.ac.ir
Web page address
https://old.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
Somayeh Jarrahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Sarshar dormitory number 12,sarshar dead end alley,Valiasr street
City
Tehran
Province
Tehran
Postal code
1961835484
Phone
+98 21 2272 1367
Email
jarrahi1364@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
علی خردمند
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Taleqani hospital, Student Blvd ,Valenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
dr.alikheradmand@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somayeh Jarrahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Sarshar dormitory number 12,sarshar dead end alley,Valiasr street
City
Tehran
Province
Tehran
Postal code
1961835484
Phone
+98 21 2272 1367
Email
jarrahi1364@gmail.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
All data can potentially be shared after de-identifying individuals
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
All researchers working in academic and scientific institutions, doctors and pharmaceutical companies will be allowed to access the information
Under which criteria data/document could be used
The applicant can access the information after providing proof of identity
From where data/document is obtainable
Applicants can contact Dr. Somayeh Jarrahi by email to receive the desired documents or data.jarrahi1364@gmail.com
What processes are involved for a request to access data/document
The applicant can communicate with the researcher through email and receive the basic data after presenting the identity documents
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