UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024369 |
|---|---|
| Receipt number | 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 00:48:31 |
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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
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
hasuohid@hirakata.kmu.ac.jp
Sponsor or person
Institute
Akaiwa Medical Association Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028051
