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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024369
Receipt No. R000028051
Scientific Title Tolerable pain reduces gastric fundal accommodation and gastric motility in healthy subjects: a crossover ultrasonographic study
Date of disclosure of the study information 2016/10/12
Last modified on 2016/10/12

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Basic information
Public title Tolerable pain reduces gastric fundal accommodation and gastric motility in healthy subjects: a crossover ultrasonographic study
Acronym Tolerable pain reduces gastric motility
Scientific Title Tolerable pain reduces gastric fundal accommodation and gastric motility in healthy subjects: a crossover ultrasonographic study
Scientific Title:Acronym Tolerable pain reduces gastric motility
Region
Japan

Condition
Condition pain
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study was to evaluate whether tolerable pain influences gastric fundal accommodation and gastric motility in healthy subjects.
Basic objectives2 Others
Basic objectives -Others pain management education for patients tolerating pain
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes gastric fundal accommodation (the cross-sectional area of the proximal stomach after incremental ingestion of up to 400 mL of a liquid meal)
Key secondary outcomes gastric motility

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 We undertook a crossover comparison study to evaluate gastric fundal accommodation and gastric motility in healthy subjects in the presence of tolerable pain. Gastric fundal accommodation and gastric motility were assessed by external ultrasonography. The cross-sectional area of the proximal stomach was measured after subjects had taken 100 mL-liquid meals four times, then the amplitude and frequency of antral contractions were measured.
Interventions/Control_2 We undertook a crossover comparison study to evaluate gastric fundal accommodation and gastric motility in healthy subjects in the absence of tolerable pain.
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria healthy volunteers
Key exclusion criteria None of the subjects had chronic pain, diabetes mellitus, had undergone gastrointestinal surgery, or was taking medication that could affect gastric motility.
Target sample size 74

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Hasuo
Organization Kansai Medical University
Division name Department of Psychosomatic Medicine
Zip code
Address 2-5-1-505 Shinmachi, Hirakata, Osaka 573-1010, JAPAN
TEL 072-804-0101
Email hasuohid@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Hasuo
Organization Kansai Medical University
Division name Department of Psychosomatic Medicine
Zip code
Address 2-5-1-505 Shinmachi, Hirakata, Osaka 573-1010, JAPAN
TEL 072-804-0101
Homepage URL
Email hasuohid@hirakata.kmu.ac.jp

Sponsor
Institute Akaiwa Medical Association Hospital
Institute
Department

Funding Source
Organization self funding
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
Address
Tel
Email

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
2016 Year 10 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
Gastric fundal accommodation, gastric motility and gastric emptying were all significantly impaired by tolerable pain (P <0.001 for all comparisons). 
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 Completed
Date of protocol fixation
2012 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 12 Day
Last modified on
2016 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028051

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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