The aim of this study was to determine the effectiveness of abdominal massage on the prevention of gastrointestinal problems in female elderly with stroke admitted to the intensive care units
Design
This study is performed as a randomized, single-blind clinical trial. The study population included female elderly patients admitted to ICU in the Hospital of Khatam. Eligible patients are randomly selected and randomly assigned to test and control groups.
Settings and conduct
The study is done in intensive care units in the Hospital of Khatam in Tehran. An abdominal massage is done according to the instructions of the National Health Service for every patient. The gastrointestinal symptom rating consists will be checked every day. Samplers will be blind to patients ‘random allocation of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 60 or older; Definitive diagnosis of stroke; Have consciousness over than 7;
Have a stroke for the first time; After a stroke, have been hospitalized for at least one week; Subjects who were being fed intermittently enterally via a nasogastric tube; Recently started on intermittent enteral feeding; Have no contraindication to an abdominal massage; Constipation is based on the constipation Assessment Scale. Exclusion criteria: The patient's or guardian's unwillingness to continue to be involved in the research project for any reason; Physician dissatisfaction, Having received (prokinetic medications, metoclopramide, erythromycin, cisapride, and anticholinergic agents); Make patients NPO for more than 12 hours for laboratory tests; Develop diarrhea more than 3 times a day.
Intervention groups
In the intervention group, Abdominal massage will be done 15 min before nasogastric tube feeding. The massage session lasts about 15 min. There is no intervention for the control group.
Main outcome variables
Gastrointestinal Symptom
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110912007529N23
Registration date:2022-04-20, 1401/01/31
Registration timing:prospective
Last update:2022-04-20, 1401/01/31
Update count:1
Registration date
2022-04-20, 1401/01/31
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of abdominal massage on the prevention of gastrointestinal problems in female elderly with stroke admitted to the intensive care
Public title
The effect of massage therapy on gastrointestinal complications of stroke patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are suffering from constipation following of stroke that will be admitted to the hospital are enrolled in the study
Exclusion criteria:
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to intervention and control groups by random block method
Blinding (investigator's opinion)
Single blinded
Blinding description
The post interventions information is collected by unbiased collaborations of the uninformed patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه شاهد
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran. Tehran Tehran Iran, Islamic Republic Of
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2021-11-01, 1400/08/10
Ethics committee reference number
Shahed.REC.1400.090
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I66.0
ICD-10 code description
Occlusion and stenosis of middle cerebral artery
2
Description of health condition studied
Constipation
ICD-10 code
K59.00
ICD-10 code description
Constipation, unspecified
Primary outcomes
1
Description
Constipation
Timepoint
Daily
Method of measurement
Bristol stool scale
2
Description
Gastric residual valume
Timepoint
Before every feeding
Method of measurement
Gavag syringe
3
Description
Distension
Timepoint
Daily
Method of measurement
By measurement circumference abdomen
4
Description
Aspiration
Timepoint
Daily
Method of measurement
Determination airway secretion PH and glucose
5
Description
Defecation
Timepoint
Daily
Method of measurement
Number of defecation
6
Description
Severity of constipation
Timepoint
Daily
Method of measurement
CAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Abdominal massage for 3 consecutive days, twice a day, morning and evening, abdominal massage for 15 minutes with 20 ml of baby oil, according to the instructions of the National Health Service (NHS) for the patient. This massage consists of 8 steps. 1. Three movements of the lower abdomen to the navel 2. Three movements from both sides of the pelvic to the pubic symphysis In the upper part and the whole abdomen 6. Repeat steps 4 and 5 .7. The horizontal movement of the abdomen from left to right 8. Vibration movements in all these points.
Category
Treatment - Other
2
Description
The control group will receive usual care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialty and Subspecialty Hospital of Khatam- ol-Anbia
Full name of responsible person
Zahra Baseri
Street address
Specialty and Subspecialty Hospital of Khatam- ol-Anbia , Rashid Yasemi St. ,Upper than Mirdamad St. ,Vali- Asr St. ,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8888 4040
Email
info@khatamhospital.org
Web page address
http://www.khatamhospital.org
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Shahriar Bijani
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3071
Email
info@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran Qom Express way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
00 3319118651
Phone
+98 21 5121 2150
Email
nrejeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran Qom Express way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
00 3319118651
Phone
+98 21 5121 2150
Email
nrejeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran Qom Freeway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2150
Email
nrejeh@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
some of the statistical data is available after being unidentifiable
When the data will become available and for how long
The access period is up to after the publication of the results.
To whom data/document is available
Data is available to academic researchers
Under which criteria data/document could be used
Use of information for academic research projects is allowed.
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
Requests for specific information should be sent by email.