UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Tolerable pain reduces gastric fundal accommodation and gastric motility in healthy subjects: a crossover ultrasonographic study
Title of the study (Brief title)	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	Hideaki Hasuo
Organization	Kansai Medical University
Division name	Department of Psychosomatic Medicine
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	Hideaki Hasuo
Organization	Kansai Medical University
Division name	Department of Psychosomatic Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Gastric fundal accommodation, gastric motility and gastric emptying were all significantly impaired by tolerable pain (P <0.001 for all comparisons).
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