Comparing the effectiveness of aromatherapy with orange and geranium essential oil on sleep quality and anxiety in patients with major thalassemia in Iran Hospital 2025
Design
Clinical trial with control group, with parallel groups, single blind, randomized on 96 patients, using toss a coin for randomization.
Settings and conduct
The research sample includes all thalassemia major patients referred to Iran Hospital in Iranshahr. Participants are randomly assigned to groups.
Before and after the intervention, the demographic characteristics form and the Spielberger anxiety and the Pittsburgh sleep quality questionnaire will be completed by the two intervention and control groups. Single-blind means that the study patients do not know which of the groups they belong to.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive diagnosis of thalassemia major, Not having known breathing problems such as asthma, not having an olfactory disorder. Patients who have sleep disorders and anxiety according to the tools..؛ Exclusion criteria: The occurrence of any serious complications caused by aromatherapy, Failure to complete the questionnaires correctly, Existence of psychological crises such as depression, bereavement and divorce...
Intervention groups
The first intervention group will be exposed to orange extract and the second intervention group will be exposed to geranium extract, and sweet almond oil will be used in the control group. 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.
Main outcome variables
Anxiety؛ Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240629062277N1
Registration date:2024-07-13, 1403/04/23
Registration timing:registered_while_recruiting
Last update:2024-07-13, 1403/04/23
Update count:0
Registration date
2024-07-13, 1403/04/23
Registrant information
Name
Hajare Rigi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3222 3948
Email address
ha_rigi@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-12, 1403/04/22
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of aromatherapy with orange and geranium essential oil on sleep quality and anxiety in patients with major thalassemia
Public title
Comparison of the effectiveness of aromatherapy with orange and geranium essential oil on sleep quality and anxiety in Thalassemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zabol University of Medical Sciences
Street address
Research Vice-Chancellor of the University, Shahid Rajaei St.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Approval date
2024-07-06, 1403/04/16
Ethics committee reference number
IR.ZBMU.REC.1403.027
Health conditions studied
1
Description of health condition studied
Thalassemia major
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score
Timepoint
Before the intervention and every week until the end of the fourth week
Method of measurement
state-trait anxiety inventory
Secondary outcomes
1
Description
Sleep quality score
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Intervention groups
1
Description
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.
Category
Other
2
Description
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.
Category
Other
3
Description
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.