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IRCT20240629062277N1 IRCT 2024-07-13 Zabol University of Medical Sciences Comparison of the effectiveness of aromatherapy with orange and geranium essential oil on sleep quality and anxiety in Thalassemia Comparing the effectiveness of aromatherapy with orange and geranium essential oil on sleep quality and anxiety in patients with major thalassemia 2024-07-12 anticipated 96 Complete https://irct.ir/trial/77769 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization (toss a coin) In this way, first a list of patients who meet the research inclusion criteria will be prepared, in this study 3 groups numbers 1 and 2 for the first group of orange essential oil, numbers 3 and 4 for the second group of geranium essential oil and numbers 5 and 6 for the third group (control) will be considered. is taken and this work will continue until all research samples are placed in one of the intervention and control groups, Blinding description: This study will be conducted in the form of a blind controlled clinical trial (this means that the subjects do not know which groups they are in). N/A Thalassemia major. Intervention 1: Intervention group1: For the purpose of aromatherapy, the first group is exposed to orange extract produced by Barij Essan Company of Kashan, which is prepared from orange peel and contains limonene, flandrene, citral (based on the presence of at least 18 mg of limonene per milliliter of the product).The intervention will be that 3 drops of essential oil will be poured on a sterile gauze, then the patient will be asked to smell the pad for one minute. After that, the gauze is fastened with a pin on a pillow or clothes at a distance of 20-25 cm from the patient's head; to smell it during three shifts and also during sleep.Aromatherapy sessions in the intervention groups are conducted three days a week (Saturday, Monday and Wednesday) and three times a day (10 am, 4 pm and at night before bedtime) for 4 weeks. Intervention 2: Intervention group2: Intervention group: The second group will be exposed to geranium extract produced by Tabib Daru Company. Geranium essential oil contains alphapinene (1.35%), citronellol (37.53%), geraniol (7.2%) and citronol formate (10.03%). The intervention will be that 3 drops of essential oil will be poured on a sterile gauze, then the patient will be asked to smell the pad for one minute. After that, the gauze is fastened with a pin on a pillow or clothes at a distance of 20-25 cm from the patient's head; to smell it during three shifts and also during sleep. Aromatherapy sessions in the intervention groups are conducted three days a week (Saturday, Monday and Wednesday) and three times a day (10 am, 4 pm and at night before bedtime) for 4 weeks. Intervention 3: Control group: In the control group, sweet almond oil will be used. This oil is obtained from a pharmacy and is completely odorless. In similar studies, this substance has been used for the control group. 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 Hajare Rigi
Nursing and midwifery school, next to Civil Registry Office, No.11 Ferdowsi St,
Zabol Iran (Islamic Republic of) 98616615881 +98 54 3222 3948 ha_rigi@zbmu.ac.ir Zabol University of Medical Sciences scientific Mahdieh poodineh Moghadam
Nursing and midwifery school, next to Civil Registry Office, No.11 Ferdowsi St,
Zabol Iran (Islamic Republic of) 9861734184 +98 54 3222 3947 moghadam07@yahoo.com Zabol University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of major Thalassemia Having minimum reading and writing literacy Absence of events and sudden stressful life conditions during the past 6 months Not having known breathing problems such as asthma, not having an olfactory disorder Not suffering from mental illnesses Not addicted to drugs, alcohol and cigarettes Not using sedatives No history of eczema and allergy to plants Satisfaction with participating in the study Not using other aroma therapy methods during the study period Patients who have sleep disorders and anxiety according to the questionnaires no limit no limit Both Other Other Other Intervention group1: For the purpose of aromatherapy, the first group is exposed to orange extract produced by Barij Essan Company of Kashan, which is prepared from orange peel and contains limonene, flandrene, citral (based on the presence of at least 18 mg of limonene per milliliter of the product).The intervention will be that 3 drops of essential oil will be poured on a sterile gauze, then the patient will be asked to smell the pad for one minute. After that, the gauze is fastened with a pin on a pillow or clothes at a distance of 20-25 cm from the patient's head; to smell it during three shifts and also during sleep.Aromatherapy sessions in the intervention groups are conducted three days a week (Saturday, Monday and Wednesday) and three times a day (10 am, 4 pm and at night before bedtime) for 4 weeks. Intervention group2: Intervention group: The second group will be exposed to geranium extract produced by Tabib Daru Company. Geranium essential oil contains alphapinene (1.35%), citronellol (37.53%), geraniol (7.2%) and citronol formate (10.03%). The intervention will be that 3 drops of essential oil will be poured on a sterile gauze, then the patient will be asked to smell the pad for one minute. After that, the gauze is fastened with a pin on a pillow or clothes at a distance of 20-25 cm from the patient's head; to smell it during three shifts and also during sleep. Aromatherapy sessions in the intervention groups are conducted three days a week (Saturday, Monday and Wednesday) and three times a day (10 am, 4 pm and at night before bedtime) for 4 weeks. Control group: In the control group, sweet almond oil will be used. This oil is obtained from a pharmacy and is completely odorless. In similar studies, this substance has been used for the control group. Anxiety score. Timepoint: Before the intervention and every week until the end of the fourth week. Method of measurement: state-trait anxiety inventory. Sleep quality score. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Zabol University of Medical Sciences Approved 2024-07-06 Ethics committee of Zabol University of Medical Sciences Research Vice-Chancellor of the University, Shahid Rajaei St. Zabol Sistan-va-Balouchestan Iran (Islamic Republic of)