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IRCT20101130005280N52 IRCT 2022-04-26 Mashhad University of Medical Sciences The effect of using blue light blocking glasses Evaluation of the effect of adding blue light blocking glasses to the treatment in patients with type 1 bipolar disorder 2022-04-20 anticipated 48 Complete https://irct.ir/trial/62659 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This is how random numbers are prepared with the help of Randomaize.com. According to the number of research samples, a number of envelopes with wrappers Aluminum (in order to avoid the clarity of the contents of the envelopes), is prepared and each of the random sequences created is registered on a card and the cards are placed inside the envelopes. In order to protect the random sequence, also on the outer surface of the envelopes Numbering is done in the same way. Finally, the lids of the letter envelopes are glued and placed in a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, they take one of the envelopes of the order, respectively, and the envelopes contain the odd number of the control group and the envelopes contain the even number, Blinding description: The studied subjects and outcome evaluators are fully aware of the research subject and the purpose and process of the study, and will enter the study after filling out the consent, according to the entry conditions. Although, They will be unaware of the contents of the envelope and the group which they are assigned (control and intervention) (so they do not predict the outcome). The envelope is prepared with aluminum foil (in order to avoid the clarity of envelope contents), and each random sequences is recorded on a card. N/A bipolar disorder. Intervention 1: Intervention group: For patients with bipolar disorder mania, glasses that specifically block blue light are used for 7 consecutive days from 6 pm until bedtime. And every day the progress of improvement will be measured through a standard questionnaire. Intervention 2: Control group: In the control group, the same glasses will be used that pass all the light spectrum. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Relevant partners should be consulted to publish the data
public Ali Saghebi
Bouali Square, Hor Ameli Blvd., Ibn Sina Psychiatric Hospital
MASHHAD Iran (Islamic Republic of) 9195983134 +98 51 3711 2721 saghebial@mums.ac.ir Mashhad University of Medical Sciences scientific Ali Saghebi
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, Boo Ali square
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3711 2721 raikaravan@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 60 years who have been diagnosed with type 1 bipolar disorder according to DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) have referred to Ibn Sina Hospital with symptoms of mania since February 1, 2022. Satisfaction with inclusion in the study 18 years 60 years Both Prior knowledge of blue block glasses History of migraine Symptoms of quitting or abusing alcohol or any other medication F30.3 Manic episode in partial remission Treatment - Other Treatment - Other Intervention group: For patients with bipolar disorder mania, glasses that specifically block blue light are used for 7 consecutive days from 6 pm until bedtime. And every day the progress of improvement will be measured through a standard questionnaire Control group: In the control group, the same glasses will be used that pass all the light spectrum. Relative satisfaction. Timepoint: At the beginning of the intervention and 2, 4, 6 days after the intervention. Method of measurement: YMRS standard questionnaire and scoring. Mashhad University of Medical Sciences Approved 2022-03-08 Ethics committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)