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IRCT20220915055965N1 IRCT 2022-12-04 Gorgan University of Medical Sciences the effect of lavender on anxiety and cognition The effect of lavender aromatherapy on anxiety and cognitive status of patients undergoing electroconvulsive therapy in 5 Azargargan hospital in2022 2022-12-06 anticipated 80 Complete https://irct.ir/trial/66097 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The present study will be conducted in order to investigate the effect of lavender aroma therapy on the anxiety and cognitive status of patients undergoing electroshock therapy in the fifth hospital of Azargorgan in 1401. After approving and receiving the code of ethics from the University of Medical Sciences, and obtaining permission from the authorities of 5 Azar Gorgan Hospital, the research will begin. This study is a clinical trial study, the number of 80 patients under treatment with ECT was selected using the available sampling method, and then based on simple random assignment, they were divided equally into two test and control groups (40 people in each group) and considering equalization in terms of number, age, and gender. They will be. The samples are equally selected from patients with bipolar disorder. After explaining the objectives of the study and how to complete the questionnaires to the research samples and assuring them about the confidentiality of the answers, the researcher first obtains informed written consent from them and then the questionnaires are completed by them. The data collection tool in this study will include demographic characteristics checklist, Montreal Cognitive Assessment (MoCA) and Beck's anxiety questionnaire. The samples will be selected considering the entry and exit criteria. The method of conducting the intervention will be that one hour before ECT, the Beck questionnaire will be completed to measure anxiety, and the MoCA questionnaire will be completed by the intervention and control groups to measure their cognitive status. Lavender drops made in Iran by Zarband company will be used. In the test group, for 10 to 20 minutes, sterile gas containing five drops of lavender essential oil, and the same amount of placebo (distilled water) in the control group, will be placed in front of the nose of the samples to inhale. One hour after receiving ECT, when the samples are in a state of consciousness and proper orientation to time, place and person, they will complete the questionnaires once again. And finally, the data will be collected and analyzed in different groups. Data analysis will be done using SPSS-16, Blinding description: To avoid bias, neither the researchers nor the patients know which drops are used, and for this purpose, the research colleagues simultaneously and separately, one person in the intervention group and the other in the control group, conduct the research. 3 Bipolar disorder. Intervention 1: Intervention group:The method of conducting the intervention will be that one hour before ECT, the Beck questionnaire will be completed to measure anxiety, and the MoCA questionnaire will be completed by the intervention group to measure cognitive status. Sterile gas containing five drops of lavender essential oil made in Iran, Zarband company, will be placed in front of the nose of the samples for 10 to 20 minutes to inhale. One hour after receiving ECT, when the patients are in a state of consciousness and proper orientation to time, place and person, they will complete the questionnaires again. Intervention 2: Control group:One hour before ECT, the Beck questionnaire to measure anxiety, and the MoCA questionnaire to measure cognitive status, will be completed by the control group. Gas impregnated with five drops of sterile distilled water (placebo) will be placed in front of the nose of the samples to inhale. One hour after receiving ECT, when the patients are in a state of consciousness and proper orientation to time, place and person, they will complete the questionnaires again. Yes - There is a plan to make this available What will be shared: The individual data of the participants without mentioning their names, as well as the results of the research, can be made available to researchers after public publication and with the permission of the university's ethics committee. When: After public release through the article. To whom: All researchers Conditions: For additional research work Where to obtain: Conductors of the research How to obtain: Request from the administrator and the reason for the request, obtaining the permission of the administrator from the ethics committee of the university.Corresponding author's email: kamkar72@yahoo.com Comments: We have not started sampling, we need to get a code from IRCT to take samples.
public Mohammad Zaman Kamkar
5 azar ave., 5 azar hospital
Gorgan Iran (Islamic Republic of) 4917769681 +98 17 3115 3365 kamkar72@yahoo.com Gorgan University of Medical Sciences scientific Mohammad Zaman Kamkar
5 azar ave,. 5 azar hospital
Gorgan Iran (Islamic Republic of) 4917763681 +98 17 3115 3365 kamkar72@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Admitted to the psychiatric department, all patients with ECT indication based on DSM-5 criteria with the diagnosis of a psychiatrist, consent to participate in the study, the ability to verbally communicate with the researchers, aged 25 to 55 years, patients benefit from minimal reading and writing literacy. (Middle or 8th grade), do not have any disease or physical disability such as speech, hearing or vision impairment, a positive smell test (olfactory nerve health test) is taken from them in such a way that the coffee sample is taken under their nose with their eyes closed and smell it), have no history of physical problems that lead to cognitive disorders such as mental retardation, epilepsy, dementia, and head trauma, no physical diseases related to anxiety and cognitive disorders such as pheochromocytoma, thyroid problems, and brain tumors, no bad Consuming alcohol and drugs, not taking anti-anxiety drugs, being aware of the time and place before the electroshock, having the physical and mental ability to answer questions, not having a history of allergies and respiratory diseases, schizophrenic patients who are dominated by negative symptoms and their reality check is impaired. are not eligible to enter the study. 25 years 55 years Both Patients who have difficulty communicating verbally, withdraw from the study, have an allergy to lavender during the intervention, decrease the level of consciousness of the patient during the study, participate in other studies that affect their anxiety and cognitive status. F31 Bipolar disorder Treatment - Drugs Placebo Intervention group:The method of conducting the intervention will be that one hour before ECT, the Beck questionnaire will be completed to measure anxiety, and the MoCA questionnaire will be completed by the intervention group to measure cognitive status. Sterile gas containing five drops of lavender essential oil made in Iran, Zarband company, will be placed in front of the nose of the samples for 10 to 20 minutes to inhale. One hour after receiving ECT, when the patients are in a state of consciousness and proper orientation to time, place and person, they will complete the questionnaires again. Control group:One hour before ECT, the Beck questionnaire to measure anxiety, and the MoCA questionnaire to measure cognitive status, will be completed by the control group. Gas impregnated with five drops of sterile distilled water (placebo) will be placed in front of the nose of the samples to inhale. One hour after receiving ECT, when the patients are in a state of consciousness and proper orientation to time, place and person, they will complete the questionnaires again. Anxiety before and after the intervention. Timepoint: One hour before and one hour after electroconvulsive therapy. Method of measurement: Based on the average scores obtained from Beck Anxiety inventory and Montreal Cognitive Assessment (MOCA). Cognitive status before and after the intervention. Timepoint: One hour before and one hour after electroconvulsive therapy. Method of measurement: Beck Anxiety Questionnaire and Montreal Cognitive Assessment (MOCA). Gorgan University of Medical Sciences Approved 2022-07-03 Golestan University of Medical Science 5 azar ave., 5 azar hospital Gorgan Golestan Iran (Islamic Republic of)