Protocol summary

Summary
This study is performed as a randomized, double blind clinical trial. The study population included patients admitted to intensive care units in two hospitals of Golestan and Imam Khomeini in Ahvaz. Eligible patients are randomly selected and randomly assigned to test and control groups. According to the studies, there are two types of abdominal massage, Classic abdominal massage and massage based on the tensegrity principle. The present study uses massage based on the tensegrity principle. This massage technique consists of 5 steps. The massage starts with brushing the skin in the abdominal area, second stage elastic deformation of the thoracolumbar fascia will be performed in the form of displacement, third stage The abdominal integuments is elastically deformed by kneading, The fourth stage involves shock movements along the armpit from top to bottom and down to the top and The last stage contains Elastic deformation of the muscles in the intercostal spaces. The patient's position is asleep to the back while undergoing massage. The angle between the bed and the patient's head is 30 to 45 degrees, and the patient's legs are placed on a pillow. This condition helps to relax the abdominal muscles. Massage is runs twice for each patient, Massage session lasts about 20 minutes. This action runs over 3 consecutive days. There is no intervention for the control group. every day, before and after the massage, gastric residual valuom and abdominal circumference Calculated and Compare.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017062134641N2
Registration date: 2017-07-26, 1396/05/04
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-26, 1396/05/04
Registrant information
Name
Alireza Abdi
Name of organization / entity
nursing and midwifery school, Kermanshah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3725 0111
Email address
arabdi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-08-11, 1396/05/20
Expected recruitment end date
2017-11-11, 1396/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of abdominal massage on gastric residual volume and abdominal circumference of patients a
Public title
The effect of abdominal massage on the gastric residual valume
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having a nasogastric tube, Loss of consciousness, had not received radiotherapy treatment on the abdominal region in the previous 6 weeks, without intestinal obstruction, abdominal surgery, or diarrhea, Lack of Deep Venus Thrombosis, Not having an aneurysm, Not having ascites, Not receiving any effective gastrointestinal medicine Exclusion criteria: Transferring the patient to other wards, death, discharge, Take out the gastric tube, Patients have intra-abdominal pressure 12 mm Hg and patients with abdominal compartment syndrome
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
None
Sample size
Target sample size: 60
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv.
City
Kermanshah
Postal code
6714634698
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
Kums.rec.1396.31

Health conditions studied

1

Description of health condition studied
Acute pulmonary edema
ICD-10 code
150.1
ICD-10 code description
Left ventricular failure

2

Description of health condition studied
head trauma
ICD-10 code
s06.7
ICD-10 code description
Intracranial injury with prolonged coma

3

Description of health condition studied
Congestive heart failure
ICD-10 code
150.0
ICD-10 code description
Congestive heart failure

Primary outcomes

1

Description
gastric residual valume
Timepoint
before anf after intervention
Method of measurement
Using a special syringe for gavage

2

Description
abdominal circumference
Timepoint
before and after intervention
Method of measurement
Using a special flexible meter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: According to the studies, there are two types of abdominal massage, Classic abdominal massage and massage based on the tensegrity principle. The present study uses massage based on the tensegrity principle. This massage technique consists of 5 steps. The massage started with brushing the skin in the abdominal area, second stage elastic deformation of the thoracolumbar fascia was performed in the form of displacement, third stage The abdominal integuments were elastically deformed by kneading, The fourth stage involves shock movements along the armpit from top to bottom and down to the top and The last stage contains Elastic deformation of the muscles in the intercostal spaces. The patient's position is asleep to the back while undergoing massage. The angle between the bed and the patient's head is 30 to 45 degrees, and the patient's legs are placed on a pillow. This condition helps to relax the abdominal muscles. Massage is runs twice for each patient, Massage session lasts about 20 minutes in each day. This action runs over 3 consecutive days. every day, before and after the massage, gastric residual valuom and abdominal circumference Calculated and Compare. For abdominal circumference measurement, a 150-cm flexible measure will be used. The beginning point for the measurement is the umbilicus.
Category
Prevention

2

Description
Control group: The control group will receive usual care contain; Change position, Lavage, Gavage and etc.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
alireza abdi
Street address
ahvaz-Golestan region- farvardin street
City
ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Kermanshah University of Medical Sciences
Full name of responsible person
behrooz hamzeh
Street address
Shahid Beheshty BLV., Kermanshah University of Medical Sciences, Kermanshah
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 for Research, Kermanshah University of Medical Sciences
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 School of Nursing and Midwifery
Full name of responsible person
alireza abdi
Position
PhD in Nursing Education-Faculty member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv. Kermanshah
City
kermanshah
Postal code
00988338279394
Phone
+98 83 3835 8258
Fax
Email
arabdi@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
alireza abdi
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv.
City
kermanshah
Postal code
00988338279394
Phone
+98 83 3835 8258
Fax
Email
arabdi@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
alireza abdi
Position
PhD in Nursing Education, Faculty member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv.
City
kermanshah
Postal code
00988338279394
Phone
+98 83 3835 8258
Fax
Email
arabdi@kums.ac.ir
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
Loading...