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IRCT20171113037428N2 IRCT 2018-03-25 Shiraz University of Medical Sciences Effects of bergamot essential oil aromatherapy on anxiety, salivary cortisol and alpha-amylase levels in patients undergoing laparoscopic cholecystectomy surgery Effects of bergamot essential oil aromatherapy on anxiety, salivary cortisol and alpha-amylase levels in patients undergoing laparoscopic cholecystectomy surgery 2018-04-21 anticipated 60 Complete https://irct.ir/trial/27696 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The simple random sampling would be used to recruitment of the participants. In order to this, every day, each one of the subjects who would be on the list of operation room would be randomly assigned a code. Then, 50% of the patients would randomly assigned to the study through table of random numbers. After that, allocation of the participants to the intervention or control groups would be done based on weeks. In doing so, the weeks would randomly assigned to two blocks (A and B). Then, six blocks with block size of four would set via the block randomization software. Each block would be placed in an envelope and each week, one of the envelopes would opened, respectively. After that, the participants who recruited through table of random numbers would be assigned to the selected blocks, Blinding description: The method of blindness is that the person who collects the questionnaires, the people who collect the laboratory tests from the patients, the people who report the laboratory tests, the statistician that performs data analysis are unaware of the treatment each patient receives. N/A Anxiety. Intervention 1: Intervention group: ŮŽAromatherapy with bergamot essential oil. Intervention 2: Control group: use of odorless grape seed oil. 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 I have not decided yet
public Fatemeh Araghi
Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) 71345-1978 +98 71 3235 7282 araghif_69@yahoo.com Shiraz University of Medical Sciences scientific Dr Niloufar pasyar
Shiraz - Namazi Square - School of Nursing and Midwifery (SA)
Shiraz Iran (Islamic Republic of) 0098-713451359 +98 71 3647 4254 npasyar@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients undergoing laparoscopic cholecystectomy surgery aged 18 years and older Can understand and speak Persian language Interested in participating in the study 18 years no limit Both Having any respiratory and allergic problems, such as asthma, systemic diseases, including metabolic and endocrine diseases such as diabetes, chronic liver and kidney disease, vision, hearing and smell problems, mental illness history confirmed by a psychologist , History of allergy to herbs, oral problems such as dry mouth and parotiditis Addiction to alcohol and drugs (such as opium, hashish, methamphetamine, etc.) Having surgery history Consumption of anti-anxiety drugs, antidepressants, narcotics, contraceptives, corticosteroids and other drugs affecting the autonomic nervous system and endocrine system F40 Phobic anxiety disorders Other Other Intervention group: ŮŽAromatherapy with bergamot essential oil Control group: use of odorless grape seed oil Anxiety. Timepoint: Before and immediately after the intervention. Method of measurement: Spielberger Anxiety questionnaire. Salivary cortisol. Timepoint: Before and immediately after the intervention. Method of measurement: Sampling of saliva. Salivary Alpha-amylase. Timepoint: Before and immediately after the intervention. Method of measurement: Sampling of saliva. Shiraz University of Medical Sciences Approved 2017-11-13 Ethics committee of Shiraz University of Medical Sciences Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz shiraz Fars Iran (Islamic Republic of)