UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062682 |
|---|---|
| Receipt number | R000071435 |
| Scientific Title | Exploring a Pain Relief Approach Using the Therapeutic Robot "Qoobo" |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/25 16:58:14 |
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Basic information
Public title
Can the Therapeutic Robot "Qoobo" Help Relieve Pain?
Acronym
Qoobo Pain Relief Study
Scientific Title
Exploring a Pain Relief Approach Using the Therapeutic Robot "Qoobo"
Scientific Title:Acronym
Qoobo Pain Study
Region
| Japan |
Condition
Condition
Experimentally induced pain in healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of Qoobo on pain perception and to explore the mechanisms underlying the effects of distraction and relaxation on pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity assessed by the Visual Analog Scale (VAS)
Key secondary outcomes
Pain threshold assessed by electrical stimulation, State anxiety measured by the State-Trait Anxiety Inventory (STAI), Comfort level assessed by the Two-Dimensional Mood Scale (TDMS), Attention level, Perceived pain relief
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
The use of the therapeutic robot Qoobo and posture (upright posture vs. relaxed posture) will be manipulated. Participants will complete the following four conditions once each, for a total of four conditions: (1) Qoobo with an upright posture, (2) Qoobo with a relaxed posture, (3) no Qoobo with an upright posture, and (4) no Qoobo with a relaxed posture. In the Qoobo conditions, participants will touch Qoobo for 2 minutes during the electrical stimulation. In the no-Qoobo conditions, participants will not touch anything. In each condition, electrical stimulation will be gradually increased over 1 minute to measure the sensory threshold and pain threshold, followed by 1 minute of stimulation at a constant intensity. After the electrical stimulation, participants will complete questionnaires assessing subjective pain intensity, state anxiety, attention, and pleasantness. The time required to complete the questionnaires will also serve as the rest period before the next condition.
Interventions/Control_2
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
1.Undergraduate or graduate students at Waseda University.
2.Individuals who provide informed consent to participate in the study after receiving an explanation of the study.
Key exclusion criteria
1.Individuals with a current illness or injury, those who regularly take medication, those experiencing extreme fatigue or sleep deprivation, or those with a history of psychotherapy or counseling.
2.Individuals participating in another multi-day experiment on the day of the present study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Tayama |
Organization
Waseda University
Division name
faculty of Human Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
04-2949-8113
jtayama@waseda.jp
Public contact
Name of contact person
| 1st name | Mitsuki |
| Middle name | |
| Last name | Suga |
Organization
Waseda University
Division name
Graduate School of Human Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
04-2947-6756
Homepage URL
21tsukimi1@akane.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee on Research with Human Subjects of Waseda University
Address
1-104 Totsukacho, Shinjuku-ku, Tokyo, 169-8050, JAPAN
Tel
03-5272-1639
rinri@list.waseda.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
早稲田大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 25 | Day |
Last modified on
| 2026 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071435
