Determining the effect of magnetic therapy on the discharge patterns of patients hospitalized in the ICU
Design
In this study, the sampling method will be easy and accessible, and intervention and control groups will be randomly assigned using minimization software in two intervention and control groups.
Settings and conduct
Special care departments of Amin, Kashani, Al-Zahra hospitals
Participants/Inclusion and exclusion criteria
Patients must be at least 18 years old and at most 65 years old
• No drug addiction
• Absence of cardiovascular problems and absence of a pacemaker according to the patient's file
• The availability of places to place magnets on the patient's body and the absence of damage to that area
Mechanical ventilation for more than 24 hours and GCS below 8
• Having a stomach tube and administering enteral nutrition
• No history of defecation pattern disorders before hospitalization through accompanying information
• No recent abdominal surgery according to the patient's file
• Absence of spinal cord cut
• Absence of sepsis according to the doctor's opinion
No delay in starting feeding (2 and more than 2 days)
• Absence of celiac disease, pancreatitis, thyroid hypofunction and hyperfunction, and active hepatitis based on the information in the file
• Not using probiotics
• Absence of pregnancy
• Not having an implant
• Absence of electrolyte disorders (hypomagnesemia, hypokalemia, hypocalcemia)
Intervention groups
The number of 64 patients eligible to enter the study are randomly divided into two test and control groups. Magnets are placed at points P6, H7 on the right and left hands, and points SP6, ST36 only on the left foot, and one point on the sole of the foot. The left related to the bladder/digestion are glued with glue.
Main outcome variables
Increasing the frequency of defecation and improving stool consistency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230610058436N1
Registration date:2023-06-24, 1402/04/03
Registration timing:registered_while_recruiting
Last update:2023-06-24, 1402/04/03
Update count:0
Registration date
2023-06-24, 1402/04/03
Registrant information
Name
Azade Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4362 5416
Email address
azade.moradi4460@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of magnetic therapy on defecation pattern in patients admitted in the ICU
Public title
Investigating the effect of magnetic therapy on defecation pattern in patients admitted in the ICU
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
• The availability of places to place magnets on the patient's body and the absence of damage to that area
• Mechanical ventilation for more than 24 hours and GCS below 8
• Having a stomach tube and administering enteral nutrition
Exclusion criteria:
No drug addiction
• Absence of cardiovascular problems and absence of a pacemaker according to the patient's file
• No history of defecation pattern disorders before hospitalization through accompanying information
• No recent abdominal surgery according to the patient's file
• Absence of spinal cord cut
• Absence of sepsis according to the doctor's opinion
• Absence of celiac disease, pancreatitis, thyroid hypofunction and hyperfunction, and active hepatitis based on the information in the file
• Not using probiotics
• Absence of pregnancy
• Not having an implant
• عدم اختلالات الکترولیت ها (هایپومنیزیمی، هایپو کالمی، هیپوکلسمی)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using minimization software. In this way, after the patient's entry into the study is confirmed, several cases related to the patient are entered into this software to match the intervention and control groups, and then the software completely randomly selects the patient in the intervention or control group. to give
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a blinded clinical trial by a statistician and data analyst who does not know about the test and control groups while entering the data and analyzing it.
Placebo
Used
Assignment
Parallel
Other design features
Combining the two methods of acupuncture and acupressure to place magnets in different places
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Management and Rehabilitation Nursing
Street address
Hazarjerib Street, Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-06-18, 1402/03/28
Ethics committee reference number
1402.041
Health conditions studied
1
Description of health condition studied
Constipation and diarrhea
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bristol scale
Timepoint
7 day
Method of measurement
Bristol scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Magnets at points P6, H7 on the right and left hands, and points SP6, ST36 only on the left foot and one point on the sole of the left foot related to the bladder/digestion, are glued with glue. The total time that the magnets in the points are located, about 35 ± 5 minutes once a day, for a week.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospital, Al Zahra Hospital, Kashani Hospital
Full name of responsible person
Mohammad Sadegh Aboutalebi
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7500
Email
aboutalebi@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Aboutalebi
Street address
Hezar Jarib st, of Isfahan university of medical sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Fax
+98 31 3668 8597
Email
aboutalebi@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Aboutalebi
Position
assistant professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
36688597
Fax
+98 31 3668 8597
Email
aboutalebi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Sadegh aboutalebi
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
خیابان هزار جریب،دانشگاه علوم پزشکی و خدمات بهداشتی درمانی اصفهان ،دانشکده پزشکی Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 81 7467 3461
Fax
+98 31 3668 8597
Email
aboutalebi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Aboutalebi
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Fax
+98 31 3668 8597
Email
aboutalebi@nm.mui.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
After printing the results of the study in the form of an article, it is possible to access the data with an official letter
To whom data/document is available
After printing the results of the study in the form of an article, it is possible to access the data with an official letter
Under which criteria data/document could be used
Send your request in writing stating the reason
From where data/document is obtainable
To submit your request, contact the following email:
aboutalebi@nm.mui.ac.ir
What processes are involved for a request to access data/document