Protocol summary

Summary
Objective: Evaluation of abdominal massage effect on return of bowel Peristalsis after cardiac surgery. Design: Double blinded randomized controlled trial. Setting: Eighty patients undergoing cardiac surgery in Ekbatan hospital at 2013. Inclusion criteria: (a) signing informed consent; (b) Age 18-70 years; (c) Time of surgery between 2.5 to 5 hours. Exclusion criteria: (a) Opium addiction; (b) Gastrointestinal Disorders; (c) Usage medications (calcium channel blockers, anti-cholinergic drugs, Psychiatry, laxative and purgative); (d) Electrolyte distribution; (e) History of spinal cord injuries or cerebral vascular accident. Intervention: 40 patients will receive abdominal massage for 5 minutes each 6 hours by trained nurse. Control: 40 patients will receive ordinary services of postoperative ICU care. Primary outcome: time of return bowel sound, gas passing and defecation that evaluate by nurse. Secondary outcome: Time length of patients stay in ICU.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012121011709N1
Registration date: 2013-05-10, 1392/02/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-05-10, 1392/02/20
Registrant information
Name
Davoud Khoshbavarrad
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1826 9213
Email address
khoshbavarrad@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research and Technology, Kermanshah University of Medical Science
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-08-06, 1392/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of abdominal massage effect on return of bowel Peristalsis after cardiac surgery in Ekbatan hospital 2013
Public title
Evaluation of abdominal massage effect on return of bowel Peristalsis after cardiac surgery in Ekbatan hospital 2013
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) signing informed consent; (b) Age 18-70 years; (c) Time of surgery between 2.5 to 5 hours. Exclusion criteria: (a) Opium addiction; (b) Gastrointestinal Disorders; (c) Usage medications (calcium channel blockers, anti-cholinergic drugs, Psychiatry, laxative and purgative); (d) Electrolyte distribution; (e) History of spinal cord injuries or cerebral vascular accident.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Sciences University of Kermanshah
Street address
Dolat Abad Boulevard - School of Nursing and Midwifery
City
Kermanshah
Postal code
Approval date
2013-04-06, 1392/01/17
Ethics committee reference number
196

Health conditions studied

1

Description of health condition studied
Ileus
ICD-10 code
K56.0
ICD-10 code description
Paralytic ileus

Primary outcomes

1

Description
Return of bowel movements
Timepoint
Three hours after the start of the intervention
Method of measurement
Self-report and auscultation

Secondary outcomes

1

Description
Length of stay in Intensive Care Uunit
Timepoint
Discharge time from ICU
Method of measurement
Clock

Intervention groups

1

Description
After cardiac surgery abdominal massage started from right lower quadrant and extended along the large intestine and ended in right lower quadrant.
Category
Rehabilitation

2

Description
In control group will not do any intervention and just recorded bowel movement returning data for evaluation with intervention group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ekbatan Hospital of Hamadan
Full name of responsible person
Davoud Khoshbavarrad
Street address
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor of Research and Technology,Kermanshah University of Medical Science
Full name of responsible person
Faird Najafi
Street address
Kermanshah University Of Medical Sciences, Beheshti blv
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research and Technology,Kermanshah University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Davoud Khoshbavarrad
Position
Graduate student
Other areas of specialty/work
Street address
Hamadan
City
Hamadan
Postal code
Phone
+98 81 1826 9213
Fax
Email
Khoshbavarrad@umsha.ac.ir khoshbavarrad@yahoo.comdkhoshbavarrad@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Behrooz Karkhanei
Position
Anesthesiologist
Other areas of specialty/work
Street address
Hamadan Besat Hospital
City
Hamadan
Postal code
Phone
+98 81182640025
Fax
Email
Karkhanei@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Davoud Khoshbavarrad
Position
Graduate Student
Other areas of specialty/work
Street address
Hamadan
City
Hamadan
Postal code
Phone
+98 81 1826 9213
Fax
Email
Khoshbavarrad@umsha.ac.irKhoshbavarrad@yahoo.comdkhoshbavarrad@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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