Determining the effect of eucalyptus oil aromatherapy on anxiety and sleep disorders in hemodialysis patients
Design
This study is a randomized controlled clinical trial with parallel groups on 90 patients undergoing hemodialysis. After meeting the inclusion criteria, participants were randomly assigned to two intervention and control groups. Randomization was performed using SPSS software.
This study is conducted without blinding.
Settings and conduct
This randomized clinical trial will be conducted on hemodialysis patients in Gonabad. In the intervention group, eucalyptus aromatherapy will be administered during each dialysis session for 6 weeks (18–24 sessions), using a gauze or tissue with 10 drops of eucalyptus essential oil attached to the patient’s collar for continuous inhalation. The control group will receive routine hemodialysis care only.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Willingness to participate
Score ≥20 on the Spielberger Anxiety Inventory and ≥5 on the PSQI
No history of psychiatric disorders
No olfactory dysfunction
No use of medications for anxiety or sleep disorders
On hemodialysis ≥6 months, three times weekly (3–5 hours/session)
Exclusion Criteria:Withdrawal from the study
Non‑adherence to study instructions
Allergy to eucalyptus or development of olfactory problems
Intervention groups
This study evaluates the effectiveness of eucalyptus aromatherapy on anxiety and sleep disorders in hemodialysis patients. The control group receives routine hemodialysis care according to the center’s protocol, including standard monitoring and nursing care. No aromatherapy intervention is provided to this group.
Main outcome variables
Anxiety, Sleep disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260422069132N1
Registration date:2026-05-10, 1405/02/20
Registration timing:prospective
Last update:2026-05-10, 1405/02/20
Update count:0
Registration date
2026-05-10, 1405/02/20
Registrant information
Name
Neda Pishbin nooghabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5723 1122
Email address
nedapishbin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-05, 1405/03/15
Expected recruitment end date
2026-08-06, 1405/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eucalyptus oil aromatherapy on anxiety and sleep disorders of hemodialysis patients
Public title
The effect of eucalyptus extract aroma on anxiety and sleep disorders in hemodialysis patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the project
Having anxiety disorders
The person does not have any mental or underlying disorders
Obtaining a score of 20 as the cut-off point of the Spielberger Anxiety Questionnaire and also obtaining a score of 5 or higher as the cut-off point of the Pittsburgh Sleep Quality Questionnaire
They had no smell problems
They were not taking any medication for anxiety or sleep disorders
The patients were undergoing hemodialysis (HD) treatment for at least 6 months, the patients underwent hemodialysis treatment (at least) three times a week, each time for three to five hours
Exclusion criteria:
Failure to comply with and complete training
Withdrawing from further participation in the study
The patient is allergic to medication or has a sense of smell disorder.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Main method: Simple random probability; in case of limitations, available sampling
Randomization method: Simple randomization, in this study, the allocation of patients to two intervention groups (inhalation/eucalyptus aromatherapy) and the control group is done by simple randomization method. For this purpose, the allocation group is determined for each patient entered into the study, based on a pre-prepared random sequence.
Randomization unit: Individual
Strategic randomization is not used in this study and randomization is performed without stratification.
The randomization tool is statistical software (SPSS)
How to create a random sequence: First, an allocation number is considered for each sample unit (patient). Then, using the random number generation function in SPSS software, a random number is assigned to each number. The list of patients is sorted from small to large based on these random numbers, and patients are placed alternately or in a predetermined sequence in the two groups "intervention" and "control" until the sample size in each group is completed.
Concealment: In order to prevent bias in assigning patients to groups, the method of opaque, non-transparent, numbered, and sealed envelopes is used sequentially.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Anxiety and Sleep Disorders in Hemodialysis Patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Outcome Variable 1:The level of anxiety in patients undergoing hemodialysis, measured using the Spielberger State–Trait Anxiety Inventory (STAI). This variable will be assessed at two time points: before the start of the intervention and at the end of the sixth week after the implementation of aromatherapy with eucalyptus essential oil. Outcome Variable 2:Sleep quality in patients undergoing hemodialysis, measured using the Pittsburgh Sleep Quality Index (PSQI). This variable will also be assessed at two time points: before the start of the intervention and at the end of the sixth week after the implementation of aromatherapy with eucalyptus essential oil.
Timepoint
After 6 weeks of hemodialysis
Method of measurement
Spielberger Anxiety Questionnaire and Pittsburgh Sleep Disorders Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The intervention group will receive aromatherapy during each dialysis session for 6 weeks (18-24 sessions, depending on the number of dialysis sessions per week (twice or three times a week)) using gauze or a tissue with 10 drops of pure eucalyptus oil, fixed to the collar of the patient's clothing, and inhaled during hemodialysis.
Category
Lifestyle
2
Description
Control group: In the control group, routine measures are performed during and after hemodialysis.