UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046095
Receipt number R000052614
Scientific Title The effect of motor imagery combined with virtual reality on analgesia in healthy participants
Date of disclosure of the study information 2021/12/12
Last modified on 2022/05/25 08:49:53

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Basic information

Public title

The effect of motor imagery combined with virtual reality on analgesia in healthy participants

Acronym

The effect of motor imagery combined with virtual reality on analgesia

Scientific Title

The effect of motor imagery combined with virtual reality on analgesia in healthy participants

Scientific Title:Acronym

The effect of motor imagery combined with virtual reality on analgesia

Region

Japan


Condition

Condition

Healthy young volunteer

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of motor imagery combined with virtual reality on analgesia in healthy participants.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pressure pain threshold
Temporal summation of pain

Key secondary outcomes

profile of mood states
Positive and negative affect schedule


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Motor imagery intervention
Ten minutes

Interventions/Control_2

Motor imagery combined with virtual reality
Ten minutes

Interventions/Control_3

Actual exercise (cycling)
Ten minutes

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

23 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy volunteers

Key exclusion criteria

Acute or chronic pain condition, pregnancy, menstruation

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Takako
Middle name
Last name Matsubara

Organization

Kobe Gakuin University

Division name

Graduate School of Rehabilitation

Zip code

651-2180

Address

518 Arise, Ikawadani-cho, Nishi-ku, Kobe, JAPAN

TEL

078-974-1551

Email

matsubar@reha.kobegakuin.ac.jp


Public contact

Name of contact person

1st name Takako
Middle name
Last name Matsubara

Organization

Kobe Gakuin University

Division name

Graduate School of Rehabilitation

Zip code

651-2180

Address

518 Arise, Ikawadani-cho, Nishi-ku, Kobe, JAPAN

TEL

078-974-1551

Homepage URL


Email

matsubar@reha.kobegakuin.ac.jp


Sponsor or person

Institute

Kobe Gakuin University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kobe Gakuin University

Address

518 Arise, Ikawadani-cho, Nishi-ku, Kobe, JAPAN

Tel

078-974-1551

Email

ethic@reha.kobegakuin.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



Other administrative information

Date of disclosure of the study information

2021 Year 12 Month 12 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

2021 Year 10 Month 11 Day

Date of IRB

2021 Year 12 Month 10 Day

Anticipated trial start date

2021 Year 12 Month 13 Day

Last follow-up date

2024 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

2021 Year 11 Month 17 Day

Last modified on

2022 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052614


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name