Determining the effect of massage and lifestyle education on gastrointestinal complications of stroke patients
Design
Clinical trial with community-based control and intervention group, with parallel groups, without blinding, randomized numbers.
Settings and conduct
Elderly people with stroke in Ghaem Hospital in Mashhad are divided into two groups: intervention and control. Lifestyle is taught to both groups. In the intervention group, Massage Scheme I LOVE U is also provided. The movement of the hand is in the form of the only one; L; O;V U is drawn along the colon and the narrow intestine on the abdomen. The duration of each abdominal massage is 15 minutes, for four weeks, performed by the patient.
Participants/Inclusion and exclusion criteria
Age 60 and older;
Definitive diagnosis of ischemic stroke;
Get 5 and more points from the CAS Constipation Assay;
Lack of history of recent surgery and the development of disorders such as pancreatitis, ulcers and gastrointestinal lesions, gastrointestinal malignancies, liver and kidney failure;
Not having ulcers, injuries and a clear infection on the abdomen;
Guava diet;
Having knowing along;
Intervention groups
In both groups, control and lifestyle interventions are taught. In the intervention group, in addition to lifestyle,I LOVE U abdominal massage training is also provided
Main outcome variables
distension, gastric residual, constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180721040547N1
Registration date:2018-11-02, 1397/08/11
Registration timing:registered_while_recruiting
Last update:2018-11-02, 1397/08/11
Update count:0
Registration date
2018-11-02, 1397/08/11
Registrant information
Name
zahra fekri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3273 0958
Email address
fekriz1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2018-10-23, 1397/08/01
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-07-17, 1398/04/26
Scientific title
The effect of massage therapy and life style education on gastrointestinal complications of stroke patients
Public title
The effect of massage therapy and life style education on gastrointestinal complications of stroke patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 and older
Definitive diagnosis of ischemic stroke
Two days of stroke
the patient has distention
Lack of history of recent surgery and the development of disorders such as pancreatitis, ulcers and gastrointestinal lesions, gastrointestinal malignancies, liver and kidney failure
Not having ulcers, injuries and a clear infection on the abdomen
The level of consciousness is above 7
Having a family member to take care of him
Not dialysis
Exclusion criteria:
the family member does't like to collaborate in research
the patients disability to be in sitting position
existence of any deficit in patient's extremities cartilages that avoid patient to do the exercises
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
At the first the researchers used the www.randomization.com website to allocate 52 numbers from 1 to 52 randomly. The the first 26 numbers considered to be in intervention group and the latter to be in control group. Then the patients will catch the number from 1 to 52. therefore according to the random numbers each patient will be allocated to intervention or control group by considering the number.
Blinding (investigator's opinion)
Not 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 Mashhad University of Medical Sciences
Street address
Ebne sina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.MUMS.REC.1397.099
Health conditions studied
1
Description of health condition studied
Cerebro vascular Attack
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarctionIncl.:Cerebrovascular accident NOS
Primary outcomes
1
Description
distension
Timepoint
daily for 4 weeks
Method of measurement
Meter
2
Description
constipation
Timepoint
daily for 4 weeks
Method of measurement
Constipation Assessment Scale
3
Description
gastric residual
Timepoint
daily for 4 weeks
Method of measurement
Gavag syringe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:I LOVE U Massage training is provided in a lifestyle approach and teaching (training for drinking, using fluids and vegetables, exercise, positioning during excretion)
Category
Lifestyle
2
Description
Control group: Lifestyle education includes training on how to cook, use fluids and vegetables, exercise, position during excretion.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Neurosurgery at Ghaem Hospital in Mashhad
Full name of responsible person
Nahid aghebati
Street address
Abn cina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
fekriz1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid aghebati
Street address
ebn cina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
fekriz1@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Aghebati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
abn cina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 513891511
Email
Aghebatin@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Aghebati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Abn cina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Aghebatin@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid aghebati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Abn cina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Aghebatin@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD