Compare the effect of topical heat therapy and room temperature on gastric residual volume and gastrointestinal tract function in patients being fed through nasogastric tube
The purpose of this study is to compare the effect of topical heat therapy and room temperature on gastric residual volume and gastrointestinal tract function in patients being fed through nasogastric tube hospitalized in internal ward. Inclusion criteria are the existence of absolute diagnosis of any internal problems by the specialist physician. All of the patients will be gavaged with food prepared in the hospital, without any clinical situation, according to reliable sources and an expert therapist, with uncertainty or restriction of using topical heat therapy.
Exclusion criteria: Discharge or death of patient, stopping gavage because of illness, conditions cause fever and temperature higher than 38 ° C.
A total of fifty patients, aged 35- 100 years old, who are admitted in Ghaem Hospital due to any medical problem, will be randomly assigned into intervention or control group. The patients in the intervention group will receive standard hot pack with a temperature of 50 ° C placed for about 23 minutes on surface of the abdomen. The patients in the control group do not receive any intervention. Gastric residual volume, abdominal distension, bowel sounds, and defecation will be controlled before and after the test in both groups. At the end the results will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050822163N1
Registration date:2015-09-07, 1394/06/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-07, 1394/06/16
Registrant information
Name
Sadighe Sadeghian
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 501 5422
Email address
sadeghiands2@gmail.com
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of topical heat therapy and room temperature on gastric residual volume and gastrointestinal tract function in patients being fed through nasogastric tube
Public title
The effect of topical heat therapy on function of the gastrointestinal tract
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age between 35-100 years old, the existence of absolute internal diagnosis such as respiratory disorders by the specialist physician, having nasogastric tube number 16- 14, have been passed more than 48 hours from starting feeding through a gastric tube, nutrition with solution prepared in the hospital, patients with consciousness level higher than 9, having non-fasting blood sugar below 220 mg/dl, there is not also surgery last month, disorders such as pancreatic, peptic ulcer disease, a history of stomach bleeding.
Exclusion criteria: Discharge or death of patient, stop gavage because of illness, conditions cause fever and temperature higher than 38 ° C.
Age
From 35 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Cases were randomly divided into the intervention and control groups. Study Type: single blind clinical trial. Researchers does not know the allocation of Patients to the control or the intervention group. Hot Pack's put on by research assistance; while researcher assesses the gastrointestinal tract function.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Iran
City
Gonabad
Postal code
9691793718
Approval date
2015-03-11, 1393/12/20
Ethics committee reference number
GMU.REC.1393.144
Health conditions studied
1
Description of health condition studied
Respiratory diseases
ICD-10 code
j00-j06,j0
ICD-10 code description
Acute upper respiratory infections Influenza and pneumonia Other acute lower respiratory infections Other diseases of upper respiratory tract Chronic lower respiratory diseases Other diseases of pleura Other diseases of the respiratory system Pneumonia in
2
Description of health condition studied
Gastrointestinal disorders
ICD-10 code
k40-k46,k2
ICD-10 code description
Hernia Other diseases of the digestive system Disorders of oesophagus in diseases classified elsewhere Disorders of other digestive organs in diseases classified elsewhere
Other bacterial intestinal infections Other bacterial foodborne intoxications, not elsewhere classified Amoebiasis Other protozoal intestinal diseases Viral and other specified intestinal infections Other gastroenteritis and colitis of infectious and unsp
Primary outcomes
1
Description
Gastric residual volume
Timepoint
Every 3 hrs exactly before doing gavage
Method of measurement
By using 50cc gavage syringe
Secondary outcomes
1
Description
Bowel sound
Timepoint
Every 3 hrs exactly before doing gavage
Method of measurement
ُُStethoscope
2
Description
Defecation
Timepoint
Every 3 hrs exactly before doing gavage
Method of measurement
Observation
3
Description
Abdominal distension
Timepoint
Every 3 hrs exactly before doing gavage
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: local heat therapy on the surface of the abdomen with Standard hot pack containing silicate with the temperature of 50°C for 23 min two times a day for 1 days.
Category
Prevention
2
Description
In Control group:without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences, Ghaem Hospital.
Full name of responsible person
Dr.Maasomeh salari
Street address
Ghaem Hospital, Ahmad abad Street, Mashhad,Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Gonabad University of Medical Sciences
Full name of responsible person
Dr.Ali mohammad pour
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Iran
City
Gonabad
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, Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Sadighe sadeghian
Position
Master degree Students in Critical Care Nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Iran
City
Gonabad
Postal code
91598-14784
Phone
+98 51 5722 2830
Fax
+98 51 5722 3814
Email
Sadeghiands2@gmail.com
Web page address
www.gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr.Ali mohammad pour
Position
Phd in Nursing Education
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Iran Gonabad
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 0578
Fax
+98 57223814
Email
amohmmadpur@yahoo.com
Web page address
www.gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Sadighe sadeghian
Position
Master degree Students in Critical Care Nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Iran
City
Gonabad
Postal code
91598-13784
Phone
+98 51 5722 2830
Fax
+98 57223814
Email
Sadeghiands2@gmail.com
Web page address
www.gmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)