Effects of bergamot essential oil aromatherapy on anxiety, salivary cortisol and alpha-amylase levels in patients undergoing laparoscopic cholecystectomy surgery

Determination of the effect of aromatherapy with bergamot essential oil on anxiety levels, salivary cortisol and alpha-amylase before laparoscopic cholecystectomy in patients referred to Imam Reza Hospital in Mashhad

Clinical trial with control group, parallel groups, randomized, double blinded

In this clinical trial, 60 patients undergoing laparoscopic cholecystectomy, admitted to Imam Reza Hospital, will be selected randomly and assigned to either control or experimental groups randomly. Before the intervention, the Spielberger state anxiety questionnaire will be completed by the patients and the saliva samples will be collected. In the experimental group, two drops of 3% bergamot essential oil, which poured on a cotton ball, will be inhaled for 20 minutes. In the control group, two drops of odorless grape seed oil will be used, then saliva samples will be collected immediately after intervention and the Spielberger state anxiety questionnaire will be completed again.

Inclusion criteria: 1. Patients undergoing laparoscopic cholecystectomy surgery aged 18 years and older 2. Can understand and speak Persian language 3. Interested in participating in the study Exclusion criteria: 1. Consumption of anti-anxiety drugs, antidepressants, narcotics, contraceptives, corticosteroids and other drugs affecting the autonomic nervous system and endocrine system 2. Addiction to alcohol and drugs (such as opium, hashish, glass, etc.) 3. Having surgery history

In the experimental group, two drops of 3% bergamot essential oil will be poured onto a cotton ball and attached to the collar of the patient and we will be asked the patient to breathe normally for 20 minutes. In the control group, two drops of odorless grape seed oil will be used.

Anxiety, salivary cortisol, salivary alpha-amylase

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.

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.