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IRCT20190418043313N1 IRCT 2022-01-13 Islamic Azad University The effect of nicotine on cognitive function The Effect of Nicotine on Cognitive functions and Positive Affection in individual with Mild Cognitive Impairment 2019-05-02 anticipated 30 Complete https://irct.ir/trial/60808 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The design of this study, is before and after intervention with the control group, Randomization description: The samples were assigned to two groups of intervention and control, randomly and using random numbers by computer software to generate random numbers (Random sequence generation). Also, the SNOSE (Sequentially numbered, opaque, sealed envelope) method was used for concealment. The number of envelope numbers was prepared and a number was placed inside each of them. The sealed envelopes were then selected by an anonymous person, and after the envelopes were opened, the type of group of participants was determined, Blinding description: This study is blinded for participants, principal investigator and co-researcher, data collectors, outcome assessor and data analyser. It should be noted that participants were explained about the purpose and intervention and informed consent was obtained from them, but to avoid bias, they were not informed about their group in study. N/A Mild cognitive impairment. Intervention 1: Intervention group: Each member of the intervention group was given a chewing gum made by Nikolife Company containing 2 mg of nicotine at a time and the participants chewed it for 2 hours. Intervention 2: Control group: Receiving of chewing gum without nicotine for 2 hours. Yes - There is a plan to make this available What will be shared: All potential data can be shared after identifying participants. When: Access period starts 6 months after the results are published To whom: Only for researchers working in academic and scientific institutions Conditions: No change or manipulation of data Where to obtain: Email address: esmailkhodadadi11@gmail.com Phone number: 00989143481951 Responsible Name: Esmail Khodadadi How to obtain: Request to send data via email, commitment not to change or manipulate data, commitment to notify results, send data after 3 working days. Comments:
public Esmail Khodadadi
Basij Highway, Azad University Square, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5157944533 +98 41 3331 8681 esmailkhodadadi11@gmail.com Islamic Azad University scientific Esmail Khodadadi
Basij Highway, Azad University Square, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5157944533 +98 41 3331 8681 esmailkhodadadi11@gmail.com Islamic Azad University Iran (Islamic Republic of) Male patients Age between 20 and 60 years Have a definitive diagnosis of mild cognitive impairment No risk of heart and brain disease No use of psychiatric drugs No risk of hypertension Not being a smoker 20 years 60 years Male Having severe cognitive impairment Inability to communicate with researcher and answer the questionnaire G31.84 Mild cognitive impairment, so stated Treatment - Other Treatment - Other Intervention group: Each member of the intervention group was given a chewing gum made by Nikolife Company containing 2 mg of nicotine at a time and the participants chewed it for 2 hours. Control group: Receiving of chewing gum without nicotine for 2 hours. Working memory score in Wechsler Memory Scale. Timepoint: Before and after 2 hours of intervention. Method of measurement: Wechsler Memory Scale. Positive affect score in PANAS questionnaire. Timepoint: Before and after 2 hours of intervention. Method of measurement: Positive and Negative Affect Schedule (PANAS). Islamic Azad University, Tabriz Branch Approved 2019-01-01 Research Ethics Committees of Islamic Azad University-Tabriz Branch Islamic Azad University, Tabriz Branch, Basij Highway, Azad University Square. Tabriz East Azarbaijan Iran (Islamic Republic of)