]>
IRCT20221026056303N1 IRCT 2026-09-29 Kermanshah University of Medical Sciences The Effect of Yarrow Essential Oil Aroma on Sleep and Mental Health in People with Generalized Anxiety Disorder: A Clinical Trial Effects of Aromatherapy with Achillea wilhelmsii C. Koch Essential Oil on Sleep Quality, Insomnia Severity, Stress, Anxiety, and Depression in Patients with Generalized Anxiety Disorder: A Randomized Controlled Trial 2026-09-23 anticipated 40 Recruiting https://irct.ir/trial/93206 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Randomization is performed using balanced block randomization with variable block sizes (4 and 6). This method ensures balance in the number of participants between the two groups over the enrollment period. Random sequence generation: The allocation sequence is generated by an independent collaborator (e.g., the project statistician, who has no role in the enrollment and intervention procedures) using R software or the randomization.com website. Enrollment: The principal investigator or research assistant enrolls the participant after confirming eligibility criteria and obtaining informed consent. Intervention assignment: After enrollment, the investigator contacts the independent collaborator who holds the allocation sequence (or the online allocation system) and provides the new participant’s identification code. Based on the predetermined sequence, the independent collaborator informs the investigator of the corresponding intervention package number. Allocation concealment: Sealed opaque envelopes or a system of pre-numbered packages are used. Each envelope/package contains the relevant code and substance (essential oil/placebo) and is opened only after the participant’s definitive enrollment and by the investigator. This mechanism prevents prediction of allocation and avoids bias, Blinding description: This study is conducted as a double-blind trial: Participant blinding: Participants do not know whether they are in the actual intervention group or the placebo group. The appearance, packaging, and method of use are identical in both groups. Patients are aware that they are participating in the study and receiving a new herbal medicine, but they remain blinded to group allocation (intervention vs. control). Outcome assessor blinding: The person who completes the questionnaires or conducts interviews at baseline and at the end of the study is unaware of the participant’s group allocation. Interventionist researcher: Due to the distinctive odor of yarrow essential oil, full blinding of the interventionist may not be feasible. To reduce bias, a "partial blinding" approach is applied: The interventionist has no role in outcome assessment. They are instructed to refrain from asking about or discussing the intervention’s effects with the participant. Preparation and coding of the intervention and placebo packages were performed by a neutral third party. Data analyst blinding: The statistician is unaware of the meaning of the group codes (A and B) until the primary analysis is complete. 3 Generalized Anxiety Disorder (GAD). Intervention 1: Intervention group: Two drops of standardized essential oil from the aerial parts of yarrow (Achillea wilhelmsii) (with chemical composition confirmed by GC-MS analysis) are dropped onto a cloth placed on the patient’s pillow. The patient applies this themselves before bedtime after receiving the necessary training beforehand. Intervention 2: Control group (placebo): Two drops of an odorless, inert carrier oil (pharmaceutical-grade oral paraffin) are administered in the same manner.Time and duration: Sessions are conducted every night, 1 minute before the participant’s usual bedtime, for 4 consecutive weeks (28 sessions in total). Usual care (medications prescribed by the psychiatrist) continues in both groups. The subsequent period will be repeated in the same manner; that is, for another 4 weeks, patients will receive the spray. No - There is not a plan to make this available Justification or reason for not sharing IPD is No permission to publish from the management of the patient recruitment center.
public Ali Zakiei
Sleep Disorders Research Center Farabi Hospital Dolatabad Boulevard Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6719851151 +98 83 3826 5255 zakieiali@gmail.com Kermanshah University of Medical Sciences scientific Ali Zakiei
Sleep Disorders Research Center Farabi Hospital Dolatabad Boulevard Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6719851151 +98 83 3826 5255 zakieiali@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of GAD by a psychiatrist. Generalized Anxiety Disorder (GAD-7) questionnaire score ≥ 10. Pittsburgh Sleep Quality Index (PSQI) score > 5 Age between 18 and 60 years Written informed consent to participate in the study. Having treatment stability (no change in the type or dosage of psychiatric medications) for at least the past month Obtaining a score of 8 or higher on the Insomnia Severity Index (ISI). 18 years 60 years Both Having other major psychiatric disorders (psychotic disorders, bipolar disorder, active substance abuse). Having acute respiratory diseases (such as severe asthma) or allergic skin conditions on the face. History of known allergy to plants of the Asteraceae/Compositae family (chicory family). Pregnancy or breastfeeding. Concurrent use of other complementary sleep-affecting treatments (such as melatonin or other herbal treatments) that the individual is not willing to discontinue. Concurrent participation in new structured psychotherapy. F41.1 Generalized anxiety disorder Treatment - Drugs Placebo Intervention group: Two drops of standardized essential oil from the aerial parts of yarrow (Achillea wilhelmsii) (with chemical composition confirmed by GC-MS analysis) are dropped onto a cloth placed on the patient’s pillow. The patient applies this themselves before bedtime after receiving the necessary training beforehand. Control group (placebo): Two drops of an odorless, inert carrier oil (pharmaceutical-grade oral paraffin) are administered in the same manner.Time and duration: Sessions are conducted every night, 1 minute before the participant’s usual bedtime, for 4 consecutive weeks (28 sessions in total). Usual care (medications prescribed by the psychiatrist) continues in both groups. The subsequent period will be repeated in the same manner; that is, for another 4 weeks, patients will receive the spray. Sleep quality. Timepoint: Changes in the total score of the Pittsburgh Sleep Quality Index (PSQI) from baseline to the end of the fourth and eighth weeks of the intervention. Method of measurement: Through changes in scores on the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Changes in the anxiety scale score. Timepoint: from baseline to the end of the fourth and eighth weeks. Method of measurement: Anxiety Scale Questionnaire. Changes in the stress scale score. Timepoint: from baseline to the end of the fourth and eighth weeks. Method of measurement: Stress Scale Questionnaire. Changes in the depression scale score. Timepoint: from baseline to the end of the fourth and eighth weeks. Method of measurement: Depression Questionnaire. Changes in the PSQI subscales (such as sleep onset latency, sleep duration, and sleep efficiency). Timepoint: from baseline to the end of the fourth and eighth weeks. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaire. Changes in the Insomnia Severity Index (ISI) questionnaire score. Timepoint: from baseline to the end of the fourth and eighth weeks. Method of measurement: Severity Index (ISI) questionnaire. Kermanshah University of Medical Sciences Approved 2026-06-15 Ethics Committee of the Faculty of Medicine, Kermanshah University of Medical Sciences Kermanshah University of Medical Sciences, Zakaria Razi Blvd., between Shahmoradi and Hafez Blvd., Kermanshah, Iran. Kermanshah Kermanshah Iran (Islamic Republic of)