Efficacy of intervention by Sensory Modulation Room in agitated patients with schizophrenia;An exploratory randomized controlled trial, a series of N-of-1 studies

Efficacy of intervention by Sensory Modulation Room in agitated patients with schizophrenia;An exploratory randomized controlled trial, a series of N-of-1 studies - Efficacy of intervention by Sensory Modulation Room in agitated patients with schizophrenia;An exploratory study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012949

Enrollment

Registered

2014-02-01

Start date

2014-02-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia

Interventions

40min program in sensory modulation room Treatment as usual without use of sensory modulation room

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Being judged to be able to express free will by multi-disciplinary team in charge 2) Meeting DSM-IV-TR criteria for schizophrenia 3) 20 years or older.Less than 60 years old 4) Finishing the assessment of sensory modulation and having used the sensory modulation room more than once 5) Patients for whom changes in main medication were presumed to be not necessary during the study 6) After explain the aims and nature of the study,capable of giving informed consent to participate in it

Exclusion criteria

Exclusion criteria: 1)History of epilepsy (Possibility of using light stimulations) 2)Serious suicidal ideation or possibility of harming themselves and others present at screening 3)Possible physical violence to intervening person at study 4)Unstable physical disorders(Performance Status 3 or 4) 5)No possibility of finishing intervention within the time limit because of discharge or hospital transfer 6)Other conditions deemed to affect the study eligibility

Design outcomes

Primary

Measure	Time frame
Visual Analogue Scale(6 items) Clinical Global Impression(CGI) Positive and Negative Syndrome Scale-Excited Component(PANSS-EC)	—

Secondary

Measure	Time frame
Pressure Pulse	—

Countries

Japan

Contacts

Public ContactMayumi Yamano

National Center of Neurology and Psychiatry Rehabilitation office

myamano@ncnp.go.jp042-341-2711

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026