UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051830 |
|---|---|
| Receipt number | R000059140 |
| Scientific Title | Evaluation of the Effects of an Intervention Using the Sensory Room on Sensory Processing Characteristics in Adults with Psychiatric Disorders: a Randomized Crossover Trial |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/02/03 10:49:10 |
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Basic information
Public title
A Study on the Effects of Relaxation Rooms Focusing on Individual Differences in Sensory Characteristics of Adults with Psychiatric Disorders
Acronym
A Study on the Effects of Relaxation Rooms in Psychiatric Disorders
Scientific Title
Evaluation of the Effects of an Intervention Using the Sensory Room on Sensory Processing Characteristics in Adults with Psychiatric Disorders: a Randomized Crossover Trial
Scientific Title:Acronym
A Randomized Crossover Trial of a Sensory Room Intervention in Psychiatric Disorders
Region
| Japan |
Condition
Condition
Neurodevelopmental Disorders, Schizophrenia, Bipolar Disorders, Depressive Disorders, Anxiety Disorders, Obsessive-Compulsive Disorders, Eating Disorders, Substance-Related Disorders, Personality Disorder
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to demonstrate the effectiveness of an intervention using the Sensory Room, which focuses on sensory processing characteristics, in adults with psychiatric disorders, and to show the changes in autonomic indices, EEG, subjective mood state, cognitive function, and social life function. In addition, changes in mental symptoms and sensory processing characteristics will also be examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in resting Respiratory Sinus Arrhythmia (RSA) before and after 30 minutes of intervention.
Key secondary outcomes
[Items Before and After the 30-Minute Intervention]
(a) Differences in RSA values in response to sensory stimuli from the Sensory Challenge Protocol (SCP)
(b) Differences in scores on the Profile of Mood States 2nd Edition (POMS2) Short Form
(c) Differences in scores on the Stanford Sleepiness Scale (SSS)
(d) Differences in EEG amplitude
(e) Differences in scores on the Multidimensional Assessment of Interoceptive Awareness (MAIA)
(f) Differences in heartbeat perception scores
[Items During the 30-Minute Intervention]
(a) RSA values over 30 minutes
(b) Observational records regarding the materials used and behaviors during the intervention
[Additional Participant Background Information]
(a) Basic demographic information
(b) Medical information
(c) Scores on the Autism Spectrum Quotient (AQ)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
[Intervention using the Sensory Room]
5.0 m2 x 2.0 m Sensory Room was created in the Human Health Science, Kyoto University Graduate School of Medicine, or in the Department of Day Care, Kyoto University Hospital, and the research subject and a licensed occupational therapist enter the room one by one. Inside the room, a bubble tube, a music player with healing music, a weighted blanket, a beaded cushion, an aroma diffuser, aroma oil, and a tactile ball are placed. At the beginning, the research administrator proposes sensory stimuli based on the A/ASP scores of the participants according to their individual sensory processing characteristics, and gradually encourages the participants to select and adjust the sensory stimuli on their own. The duration of each intervention is set to 30 minutes, with a washout period of at least one week before participants receive the other intervention.
Interventions/Control_2
[Intervention using static activities]
Participants will be asked to perform low intensity activities such as knitting, origami, puzzles, reading, etc. in a seated position for less than about 3 METs. The location will be a private room of the same size as the sensory room, or a quiet place separated by partitions, etc., with lighting. The research subject and the research administrator, who is a licensed occupational therapist, enter the room one by one, and the research subject freely chooses the work activity. The duration of each intervention is set to 30 minutes, with a washout period of at least one week before participants receive the other intervention.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a)Age at registration is between 18 or older and 65 years or younger at the time of enrolment
(b)Have a diagnosis of Neurodevelopmental Disorders, Schizophrenia, Bipolar Disorders, Depressive Disorders, Anxiety Disorders, Obsessive-Compulsive Disorders, Eating Disorders, Substance-Related Disorders, Personality Disorder in the DSM-5 of the American Psychiatric Association
(c)Have a prescription for psychiatric occupational therapy
(d)No plans to change primary medication during the intervention period
(e)Total score of 1 or more points on the JSI-mini (Japanese Sensory Inventory mini)
Key exclusion criteria
(a)Have cardiac complications
(b)Cardiac pacemaker user
(c)Have a history of epilepsy
(d)Have organic or functional abnormalities of vision, hearing, touch, smell or taste
(e)Resistance or fear of confined spaces
(f)Risk of harm to others or self-harm
(g)Unlikely to complete the study period due to discharge or transfer from hospital
(h)Difficulties with participation are envisaged according to the decision of the attending physician
(i)Any other history of visual or hearing impairment, language comprehension disorder, mental disorder or motor dysfunction that might interfere with the performance of the tasks of this study
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Inadomi |
Organization
Kyoto University
Division name
Department of Human Health Sciences, Graduate School of Medicine
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3965
inadomi.hiroyuki.5e@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Irie |
Organization
Kyoto University
Division name
Department of Human Health Sciences, Graduate School of Medicine
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3968
Homepage URL
irie.keisuke.8n@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japanese Association of Occupational Therapists (JAOT)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
MEXT(Japan)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院（京都府），京都大学医学部人間健康科学科（京都府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059140
