The effect of heat therapy on constipation in ICU patients
Design
Patients will be randomly divided into intervention and control groups (30 patients in each group). The study will be single-blind and with parallel groups.
Settings and conduct
The study will be conducted in the intensive care units of Valiasr and Amir al-Momenin hospitals. The study will be one-blind.
In the experimental group, local heat treatment with a temperature of 50 ° C will be performed on the abdominal surface.
In the control group, in addition to routine treatments, hot packs will be used at the same time as the intervention group without warming up twice a day after the meal.
Participants/Inclusion and exclusion criteria
F) Inclusion criteria:
1. Age between 20 and 85
2. Constipation (not having bowel excretion during the last 24 hours)
3. No ulcer or injury or obvious infection in the abdomen
4. No disorders such as pancreatitis, gastrointestinal malignancies and ulcers or gastrointestinal lesions.
5. A history of gastrointestinal bleeding
6. No history of CVA and neurological diseases
Exclusion criteria:
1. Not willing to continue participating in the study
2. Discharge or death of the patient
3. Conditions that lead to fever and high body temperature above 38 ° C
Intervention groups
In the experimental group, local heat treatment with a temperature of 50 ° C will be performed on the abdominal surface.
In the control group, in addition to routine treatments, hot packs will be used at the same time as the intervention group without warming up twice a day after the meal.
Main outcome variables
The impact of heat therapy on constipation in ICU patients will be assessed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180519039711N1
Registration date:2020-01-14, 1398/10/24
Registration timing:registered_while_recruiting
Last update:2020-01-14, 1398/10/24
Update count:0
Registration date
2020-01-14, 1398/10/24
Registrant information
Name
Mohamad Golitaleb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3506
Email address
m.golitaleb@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-09, 1398/10/19
Expected recruitment end date
2020-07-09, 1399/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Thermotherapy on the constipation in patients admitted to intensive care units
Public title
The effect of heat therapy on constipation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age between 20 and 85
2. Constipation (not having bowel excretion during the past 24 hours)
3. No ulcer or injury or obvious infection in the abdomen
4. No disorders such as pancreatitis, gastrointestinal malignancies and ulcers or gastrointestinal lesions.
5. A history of gastrointestinal bleeding
6. No history of CVA and neurological diseases
Exclusion criteria:
1.Unwilling to continue studying
2. Discharge or death of the patient
3. Conditions that lead to fever and high body temperature above 38 ° C
Age
From 20 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into intervention and control groups. Sixty patients were randomly assigned to either the intervention or control groups, initially 6 blocks of 10 different T and C letters (which represent the intervention and control groups) (30) from the intervention group and 30 from the intervention group. People belong to the control group). Then the haba block was randomly selected to obtain a 60-sided combination of blocks. It opens to tell which group the patient falls into.
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical caregivers, data analysts, and patients are not aware of being in the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Deputy of Education and Research,Campus University of Medical Sciences site,Basij square,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
1398.236.IR.ARAKMU.REC
Health conditions studied
1
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Constipation
Timepoint
Before and after intervention
Method of measurement
check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the experimental group, topical heat treatment with a temperature of 50 ° C will be performed on the abdominal surface.
Category
Other
2
Description
Control group: In the control group, in addition to routine treatments, hot packs will be used at the same time as the intervention group without warm-up twice a day after meals at the abdominal level.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
mohamadgolitaleb
Street address
Basij square. Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/amirhos/fa
2
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
mohamadgolitaleb
Street address
VALIASR Hospital .valiasr Square.Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/valiasrhos
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. alireza kamali
Street address
Education and Research Deputy of Arak University of Medical Sciences, Basij Square, Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Web page address
http://arakmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
mahtabfarahani
Position
nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences. Basij square. Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3417 3503
Email
mahtabfarahanie@gmail.com
Web page address
http://arakmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohamad Golitaleb
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3417 3506
Fax
+98 86 3223 1283
Email
m.golitaleb@arakmu.ac.ir
Web page address
http://arakmu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
mahtabfarahani
Position
nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences. Basij square. Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3417 3503
Email
mahtabfarahanie@gmail.com
Web page address
http://arakmu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The information will be published in the final report and article.
When the data will become available and for how long
The information will be published in the final report and article.
To whom data/document is available
The information will be published in the final report and article.
Under which criteria data/document could be used
The information will be published in the final report and article.
From where data/document is obtainable
The information will be published in the final report and article.
What processes are involved for a request to access data/document
The information will be published in the final report and article.
Comments
The information will be published in the final report and article.