NIPH Clinical Trials Search

A clinical study evaluating the effects of scent spray on sleep in patients with psychiatric disorders

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	psychiatric disorders
Date of first enrollment	20/02/2026
Target sample size	50
Countries of recruitment
Study type	Interventional
Intervention(s)	The exposure period is set to 10 days. In the fragrance group, true lavender (L. angustifolia) essential oil is automatically sprayed at night (lights off until just before waking), and grapefruit essential oil is sprayed upon waking (6:45 AM to 7:05 AM). For the non-fragranced group, the same equipment and controls are used, but the spray is odorless water

Outcome(s)

Primary Outcome

Change from baseline in sleep quality (OSA Sleep Questionnaire MA version) on the third day of exposure period with spraying

Secondary Outcome

1) Total score for sleep quality (OSA Sleep Questionnaire MA version) during the exposure period, change from baseline to each assessment point for each factor, scores at each assessment point, and changes over time 2) Change in sleep restorativeness during the exposure period at each assessment point, scores at each assessment point, and changes over time, and changes from baseline 3) Changes in mood and emotional state (POMS: Profile of Mood States) during the habituation period and at each assessment point during the exposure period, scores at each assessment point, and changes over time 4) Number of nighttime nurse call events during the habituation period and at each assessment point during the exposure period, and changes over time, and changes from baseline 5) Changes over time in heart rate and respiratory rate during the habituation period and exposure period, measured by bed-mounted motion sensors, and changes from baseline 6) Changes in the Numerical Rating Scale (NRS) score from baseline to each assessment point during the exposure period, scores at each assessment point, and changes over time, evaluating the extent to which patients require nursing care 7) Changes in patient independence (FAM: Functional Assessment Measure) during the habituation period and at each assessment point during the exposure period, scores at each assessment point, and changes over time 8) Number of days spent in a private room with exemption from private room fees 9) Length of hospital stay 10) Safety (adverse events, side effects)

Key inclusion & exclusion criteria

Age minimum	>= 26age old
Age maximum	<= 75age old
Gender	Both
Include criteria	Inclusion Criteria for Primary Registration 1)Patients voluntarily admitted to or involuntarily committed to a psychiatric ward 2)Patients scheduled to occupy a private room in the psychiatric ward for 14days or longer 3)Patients aged 26 to 75 years who can provide written informed consent 4)Patients who, during the 3 days prior to screening, took an average of 15 minutes or more to fall asleep after deciding to sleep (excluding time spent in bed using smartphones or reading) Inclusion Criteria for Secondary Registration 1)Patients with an average standardized score of less than 44 points on the OSA Sleep Questionnaire MA version over the 3 days of the habituation period
Exclude criteria	1)Patients with a GAF (Global Assessment of Functioning) score below 10 at admission 2)Patients with hypersensitivity to the scents of lavender or grapefruit 3)Patients who checked the box indicating they cannot tolerate prolonged stays in rooms filled with this scent in the screening survey regarding scent preference 4)Patients with olfactory dysfunction or allergic rhinitis However, patients who can perceive the scents of lavender and grapefruit may be included 5)Patients isolated or physically restrained under the Act on Mental Health and Welfare for Persons with Mental Disorders or Disabilities 6)Patients determined by their attending physician to have significant suicidal ideation 7)Patients deemed by their attending physician to pose a high risk of harming others 8)Patients with dementia 9)Patients deemed incapable of providing informed consent for participation in the study (Determined by the investigators in accordance with the Procedure for Assessing Capacity to Give Informed Consent [Attachment]) 10)Patients unable to independently complete questionnaire surveys 11)Patients deemed ineligible by the principal investigator or sub investigators