Effect of aromatherapy with rosa Damascena essence on nausea and vomiting in patients with breast cancer undergoing chemotherapy

Determining Effect of aromatherapy with rosa Damascena essence on nausea and vomiting in patients with breast cancer undergoing chemotherapy.

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3on 76 patients. Allocation software was used for randomization.

Women with breast cancer referred to Ayatollah Khansari Hospital in Arak will be included in the study if they are eligible and will be randomly divided into two groups of intervention and control. This study will be performed in a double-blind way so that the person who accommodate the provided packet, the person who Assess the outcome of the intervention and data Analyzer are blinded.

Inclusion criteria: Age over 18 years،Having a severity of nausea above 3 cm using the 10 cm VAS scale, definitive diagnosis of breast cancer،Healthy sense of smell. Exclusion criteria:History of lung diseases such as asthma, allergies.History of liver and kidney diseas،Having mental illness،Having migraines and chronic headaches.

Intervention group: given 3 pads, a dropper and rose essence with a purity of 40% from Kashan Parsian Company. After chemotherapy it should be taught to pour 6 drops from dropper content on the pad before serving each meal (morning noon Night) for 24 hours.and put it at a 30 cm distance of their nose and inhale its content for 20 minutes normally. Control group: distilled water should be inhaled instead of rose essence in a similar، droppers of the same shape, size.

Severity of nausea،frequency of vomiting،frequency of retching

Samples are entered into the study by non-random(purposive) sampling according to the inclusion criteria.In this study, we will use the Restricted randomization method of block randomization. Blocked randomization is usually used to balance the number of samples allocated to each of the studied groups. This feature helps researchers to equalize the number of samples allocated to each of the studied groups in cases where basics analysis are required during the sampling process. All blocks are the same size, and in this two-group experiment we will have blocks of size 4 (including 2 participants in the intervention group and2 participants in the control group). Random allocation software is also used for randomization. These random sequence generation software in addition to simple randomization, are able to generate sequences by blocking method. To conceal, we use Allocation concealment, is a technique that ensures that random allocation sequences are performed without knowing which patient will receive which treatment. Using sealed envelopes with random sequence (envelopes opaque, sealed, numbered sequentially),each of the random sequences created is recorded on a card and the cards are placed inside the envelopes. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box، respectively.

After obtaining the written consent of the participants, the prepared packages including (dropper containing distilled water, rose essence in the same shape and size as in the paper packages, pads and pins) will be given to the patients after the completion of their chemotherapy. They are taught how to use the contents of the package at home. In this way, there is no communication and contact between the participants of the intervention and control group. No odor from the dropper can be spread in the hospital that cover with a paper box. 1. One who ( except researcher) accommodate the provided packets in the same shapes and sizes to the patients، whether the which packet is placebo or intervention is uninformed. 2. The person involved in information analysis is not involved in collecting information after the intervention. 3. The person who contacts the participants to evaluate the outcome of the intervention is unaware of the allocation of participants into two groups.