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IRCT20260422069132N1 IRCT 2026-05-10 Gonabad University of Medical Sciences The effect of eucalyptus extract aroma on anxiety and sleep disorders in hemodialysis patients. The effect of eucalyptus oil aromatherapy on anxiety and sleep disorders of hemodialysis patients 2026-06-05 anticipated 90 Complete https://irct.ir/trial/89633 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, 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. N/A Anxiety and Sleep Disorders in Hemodialysis Patients. Intervention 1: 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. Intervention 2: Control group: In the control group, routine measures are performed during and after hemodialysis. No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information is available
public Neda Pishbin nooghabi
No. 13, 6th 22 Bahman Street, Nooghab, Gonabad, Iran
Gonabad Iran (Islamic Republic of) 9691896389 +98 51 5723 1122 nedapishbin@gmail.com Gonabad University of Medical Sciences scientific Neda Pishbin nooghabi
No. 13, 6th 22 Bahman Street, Nooghab, Gonabad, Iran
Gonabad Iran (Islamic Republic of) 9691896389 +98 51 5723 1122 nedapishbin@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both 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. Lifestyle Lifestyle 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. Control group: In the control group, routine measures are performed during and after hemodialysis. 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. Gonabad University of Medical Sciences Approved 2023-09-20 Ethics committee of Gonabad University of Medical Sciences No. 13, 6th 22 Bahman Street, Nooghab, Gonabad, Iran Gonabad Razavi Khorasan Iran (Islamic Republic of)