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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008044
Receipt No. R000009473
Scientific Title Effects of transcutaneous electrical nerve stimulation in abdominal postoperative patients: A prospective randomized single-blind study
Date of disclosure of the study information 2012/05/28
Last modified on 2013/05/30

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Basic information
Public title Effects of transcutaneous electrical nerve stimulation in abdominal postoperative patients: A prospective randomized single-blind study
Acronym Effects of transcutaneous electrical nerve stimulation in abdominal postoperative patients
Scientific Title Effects of transcutaneous electrical nerve stimulation in abdominal postoperative patients: A prospective randomized single-blind study
Scientific Title:Acronym Effects of transcutaneous electrical nerve stimulation in abdominal postoperative patients
Region
Japan

Condition
Condition The patients who receive elective abdominal surgery.
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effects of transcutaneous electrical nerve stimulation in abdominal postoperative patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Visula analog scale(rest pain, sit up pain, cough pain), vital capacity, cough peak flow
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Electrical stimulation 60min/day for 3days.
Interventions/Control_2 Sham electrical stimulation 60min/day for 3days.
Interventions/Control_3 No treatment.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who receive elective abdominal surgery.
Key exclusion criteria Contraindications for electrical stimulation (e.g.,a pacemaker),inability to give informed consent form.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsunori Tokuda
Organization Heisei Memorial Hospital
Division name Department of Rehabilitation
Zip code
Address 827 Shijyo-cho, Kashihara-city, Nara
TEL 0744-29-3300
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsunori Tokuda
Organization Heisei Memorial Hospital
Division name Department of Rehabilitation
Zip code
Address 827 Shijyo-cho, Kashihara-city, Nara
TEL 0744-29-3300
Homepage URL
Email H1081006@kio.ac.jp

Sponsor
Institute Heisei Memorial Hospital
Institute
Department

Funding Source
Organization Kio 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
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
2012 Year 05 Month 28 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 Completed
Date of protocol fixation
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 28 Day
Last modified on
2013 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009473

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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