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IRCT20180324039145N2 IRCT 2018-09-25 Department of Obstetrics and Gynecology, Faculty of Medicine, Ahi Evran University Rose oil aromatherapy treatments for diysmenorrhea The effects of aromatherapy with rose oil (Rosa damascena Mill.) inhalation on primary dysmenorrhea: A prospective randomized controlled clinical trial 2018-10-01 anticipated 86 Complete https://irct.ir/trial/33411 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random number generation program of the Microsoft Office Excel program will be used to make randomization sequence. The cards named Group Rose (Group R) and Group Control (Group K) will be used to conceal the randomization sequence. The method of concealment will be closed envelopes. 86 blocks will be used for randomization. N/A Primary dysmenorrhea. Intervention 1: Intervention group 1 (Group Rose or Group R): The Rose oil will be produced through distillation method at Ahi Evran University Faculty of Agriculture in the region of the Kırşehir, Turkey. The rose oil product used in this study is not licensed in the country. Rose oil product used in this study contains Citronellol (%26,14), Nonadecane (%21,32), Heneicosane (%10,33), Geraniol (%5,08), Methyl Eugenol (%1,46), Ethanol (%0,48), Linalool (%0,12). The dark bottle, containing 2-3 drop rose oil, and odorless tissue paper which has the same trademark and specification will be given to the volunteers. Firstly, the patients will use a standard analgesic drug (diclofenac sodium 50 mg enteric film tablet, max three times a day) (Voltaren, Novartis). And then they will evacuate the rose oil in the bottle onto the tissue paper. They will cover on their faces with this tissue and they will sniff it for 15 minutes (one time). Intervention 2: Intervention group 2 (Group C): The patients with VAS score >4 will use only a standard analgesic drug (diclofenac sodium 50 mg enteric film tablet, maximum three times a day)(Voltaren, Novartis). 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 further information
public Recai Dagli
No.10, Bagbasi st., Kirsehir
Kirsehir Turkey 40100 +90 386 213 45 15 recai.dagli@ahievran.edu.tr Faculty of Medicine, Ahi Evran University scientific Recai Dagli
Bagbasi street.
Kirsehir Turkey 40100 +90 386 213 45 15 recai.dagli@ahievran.edu.tr Faculty of Medicine, Ahi Evran University Turkey The patients diagnosed the primary dysmenorrhea have a painful menstrual period complaint in the ASA (American Society of Anesthesiologists) I risk group in the age range of 18-24 years old 18 years 24 years Female The patients who are constantly using analgesics for other reasons The patients who are treated for any upper respiratory tract disease that may cause edema in the nasal mucosa and may prevent smelling The patients who have anosmia diagnosed by otorhinolaryngologists The patients who have abnormal menstrual bleeding The patients who have allergies to rose oil and analgesic drugs, the asthma-like respiratory disease N94.4 Primary dysmenorrhea Treatment - Drugs Treatment - Drugs Intervention group 1 (Group Rose or Group R): The Rose oil will be produced through distillation method at Ahi Evran University Faculty of Agriculture in the region of the Kırşehir, Turkey. The rose oil product used in this study is not licensed in the country. Rose oil product used in this study contains Citronellol (%26,14), Nonadecane (%21,32), Heneicosane (%10,33), Geraniol (%5,08), Methyl Eugenol (%1,46), Ethanol (%0,48), Linalool (%0,12). The dark bottle, containing 2-3 drop rose oil, and odorless tissue paper which has the same trademark and specification will be given to the volunteers. Firstly, the patients will use a standard analgesic drug (diclofenac sodium 50 mg enteric film tablet, max three times a day) (Voltaren, Novartis). And then they will evacuate the rose oil in the bottle onto the tissue paper. They will cover on their faces with this tissue and they will sniff it for 15 minutes (one time). Intervention group 2 (Group C): The patients with VAS score >4 will use only a standard analgesic drug (diclofenac sodium 50 mg enteric film tablet, maximum three times a day)(Voltaren, Novartis) Visuel analog scale (VAS) pain scores. Timepoint: Before and after administration in the menstrual period for each patient. Method of measurement: Visuel analog scale (VAS) (between 1-10 score). Analgesic consumption of the patients for twenty-four hours. Timepoint: First twenty-four hours. Method of measurement: Asking from patients. Department of Obstetrics and Gynecology, Faculty of Medicine, Ahi Evran University Approved 2018-05-22 Clinical Investigations Ethics Committee, the Ahi Evran University No.100, Bagbasi St., Kirsehir, Turkey Kirsehir Kirsehir Turkey