Tokyo, March 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060962) titled 'Effect of Japanese Essential Oil Aromatherapy on Examination-Related Anxiety Reduction and Autonomic Nervous Activity' on March 17.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - Asahikawa Medical Univerity

Condition: Condition - Malignant Neoplasms in Patients Undergoing FDG-PET/CT Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effect of Japanese essential oil aromatherapy on examination-related anxiety in patients undergoing FDG-PET/CT using the State-Trait Anxiety Inventory-State (STAI-S). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Control group: Water vapor is intermittently diffused for 30 minutes using a nebulizing diffuser to reproduce an environment without aroma stimulation. Interventions/Control_2 - Japanese essential oils (Citrus unshiu and yuzu) are intermittently diffused for 30 minutes using a nebulizing diffuser.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients scheduled to undergo FDG-PET/CT for cancer diagnosis at Asahikawa Medical University Hospital Aged 20 years or older and capable of providing informed consent No diagnosis of severe cognitive impairment Judged to be in a stable physical and mental condition and able to undergo the study procedures No known hypersensitivity or allergy to aromatic components Provided written informed consent for participation in the study Key exclusion criteria - History of fragrance hypersensitivity, asthma, or severe anxiety disorders that may cause adverse reactions to aroma stimulation Use of medications affecting heart rate variability (e.g.,beta blockers or antiarrhythmic drugs) or use of cardiac devices such as pacemakers Presence of psychiatric disorders or dementia that makes it difficult to appropriately respond to questionnaires Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 01 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069761

Disclaimer: Curated by HT Syndication.