]>
IRCT20211117053090N1 IRCT 2022-01-22 Arak University of Medical Sciences The effect of aroma with rose damascena essence on nausea and vomiting of chemotherapy Effect of aromatherapy with rosa Damascena essence on nausea and vomiting in patients with breast cancer undergoing chemotherapy 2022-01-10 anticipated 76 Complete https://irct.ir/trial/60088 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 3 Chemotherapy-induced nausea and vomiting in breast cancer. Intervention 1: Intervention group: 38 women with breast cancer participated in the study according to the inclusion criteria. Each participant was given a package containing 20ml dropper bottle (containing rose essence prepared by parsian (Medina Al-Nabi) Company with a purity of 40%) ، three pads (10 *10 cm ) and a pin. After completing chemotherapy ،it should be taugh to pour 6 drops of dropper bottle content after going to home،which include rose essence of 40%purity on the pad and every given pad for every turn،before serving each main meal(morning, noon, and night) during 24 hours in a 30cm distant of their nose attached to their collar of clothes by a pin.This procedure was performed three times a day (morning, noon, and night). After the intervention (24 hours after chemotherapy), by phone Or face-to-face، Rhodes and VAS questionnaires are filled out to measure nausea and vomiting and sent to the data analyst. Intervention 2: Control group: 38 women with breast cancer who participated in the study according to inclusion criteria. A package containing a 20 ml dropper bottle ( containing distilled water), three pads (10 x 10 cm) and a pin given to participants . After completing chemotherapy it shoud be taugh to Pour 6 drops of the contents of the dropper bottle after going to home،which include distilled water on the pad and every given pad for every turn،before serving each main meal(morning, noon, and night) during 24 hours in a 30cm distant of their nose attached to their collar of clothes by a pin.This procedure was performed three times a day (morning, noon, and night) After the intervention (24 hours after chemotherapy), by phone Or face-to-face Rhodes and VAS questionnaires are filled out to measure nausea and vomiting and sent to the data analyst. 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 There is no more information
public Kiarash Tabaraei
No. 182, Nabi Akram Alley, East Ferdowsi St, Postal Code 6861944468
Aligudarz Iran (Islamic Republic of) 6861944468 +98 66 4332 3985 kiarashtabaraei@gmail.com Arak University of Medical Sciences scientific Kiarash Tabaraei
No. 182, Nabi Akram Alley, East Ferdowsi St., Postal Code 6861944468
Aligoudarz Iran (Islamic Republic of) 6861944468 +98 66 4332 3985 kiarashtabaraei@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of breast cancer by oncologist and pathologist Chemotherapy with drugs that cause moderate to severe nausea Having a nausea severity above 3 cm using the 10 cm VAS scale Healthy sense of smell Being over 18 years old 18 years no limit Female Having migraines and chronic headaches Having a history of asthma and allergy to rosa damacena History of drug and alcohol addiction Having mental illness Having liver and kidney disease Rehabilitation Rehabilitation Intervention group: 38 women with breast cancer participated in the study according to the inclusion criteria. Each participant was given a package containing 20ml dropper bottle (containing rose essence prepared by parsian (Medina Al-Nabi) Company with a purity of 40%) ، three pads (10 *10 cm ) and a pin. After completing chemotherapy ،it should be taugh to pour 6 drops of dropper bottle content after going to home،which include rose essence of 40%purity on the pad and every given pad for every turn،before serving each main meal(morning, noon, and night) during 24 hours in a 30cm distant of their nose attached to their collar of clothes by a pin.This procedure was performed three times a day (morning, noon, and night). After the intervention (24 hours after chemotherapy), by phone Or face-to-face، Rhodes and VAS questionnaires are filled out to measure nausea and vomiting and sent to the data analyst. Control group: 38 women with breast cancer who participated in the study according to inclusion criteria. A package containing a 20 ml dropper bottle ( containing distilled water), three pads (10 x 10 cm) and a pin given to participants . After completing chemotherapy it shoud be taugh to Pour 6 drops of the contents of the dropper bottle after going to home،which include distilled water on the pad and every given pad for every turn،before serving each main meal(morning, noon, and night) during 24 hours in a 30cm distant of their nose attached to their collar of clothes by a pin.This procedure was performed three times a day (morning, noon, and night) After the intervention (24 hours after chemotherapy), by phone Or face-to-face Rhodes and VAS questionnaires are filled out to measure nausea and vomiting and sent to the data analyst. Severity of Nausea. Timepoint: 15 minutes before the start of chemotherapy (initially study) and 24 hours after the intervention. Method of measurement: Visual Analogue Scale. The frequency of vomiting. Timepoint: 15 minutes before the start of chemotherapy (initially study) and 24 hours after the intervention. Method of measurement: Rhodes Index. The frequency of retching. Timepoint: 15 minutes before the start of chemotherapy (initially study) and 24 hours after the intervention. Method of measurement: Rhodes Index. Amount of vomiting. Timepoint: 15 minutes before the start of chemotherapy (initially study) and 24 hours after the intervention . Method of measurement: Rhodes Index. Distress score of vomiting. Timepoint: 15 minutes before the start of chemotherapy (initially study) and 24 hours after the intervention. Method of measurement: Rhodes Index. Distress score of retching. Timepoint: 15 minutes before the start of chemotherapy (initially study) and 24 hours after the intervention. Method of measurement: Rhodes Index. Total score of retching. Timepoint: 15 minutes before the start of chemotherapy (initially study) and 24 hours after the intervention. Method of measurement: Rhodes Index. Total score of vomiting. Timepoint: 15 minutes before the start of chemotherapy (initially study) and 24 hours after the intervention. Method of measurement: Rhodes Index. Arak University of Medical Sciences Approved 2021-11-22 Ethics committe of Arak University of Medical Sciences Code3848176341 ,Arak University of Medical Sciences،Next to Amir Al-Momenin Hospital، Basij Square،Phone:086-34173639 Arak Markazi Iran (Islamic Republic of)