Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Gastrointestinal Symptom
General information
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Reason for update
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The sample size was written incorrectly, it was corrected
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110912007529N23
Registration date:
2022-04-20, 1401/01/31
Registration timing:
prospective
Last update:
2023-01-21, 1401/11/01
Update count:
1
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Registration date
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2022-04-20, 1401/01/31
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-04-21, 1401/02/01
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Expected recruitment end date
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2022-09-23, 1401/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effectiveness of abdominal massage on the prevention of gastrointestinal problems in female elderly with stroke admitted to the intensive care
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Public title
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The effect of massage therapy on gastrointestinal complications of stroke patients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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:
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Age
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From 60 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation of patients to intervention and control groups by random block method
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The post interventions information is collected by unbiased collaborations of the uninformed patients.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-11-01, 1400/08/10
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Ethics committee reference number
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Shahed.REC.1400.090
Health conditions studied
1
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Description of health condition studied
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Stroke
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ICD-10 code
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I66.0
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ICD-10 code description
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Occlusion and stenosis of middle cerebral artery
2
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Description of health condition studied
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Constipation
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ICD-10 code
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K59.00
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ICD-10 code description
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Constipation, unspecified
Primary outcomes
1
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Description
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Constipation
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Timepoint
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Daily
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Method of measurement
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Bristol stool scale
2
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Description
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Gastric residual valume
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Timepoint
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Before every feeding
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Method of measurement
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Gavag syringe
3
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Description
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Distension
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Timepoint
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Daily
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Method of measurement
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By measurement circumference abdomen
4
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Description
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Aspiration
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Timepoint
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Daily
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Method of measurement
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Determination airway secretion PH and glucose
5
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Description
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Defecation
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Timepoint
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Daily
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Method of measurement
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Number of defecation
6
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Description
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Severity of constipation
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Timepoint
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Daily
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Method of measurement
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CAS questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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The control group will receive usual care.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahed University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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some of the statistical data is available after being unidentifiable
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When the data will become available and for how long
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The access period is up to after the publication of the results.
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To whom data/document is available
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Data is available to academic researchers
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Under which criteria data/document could be used
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Use of information for academic research projects is allowed.
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From where data/document is obtainable
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Corresponding author
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What processes are involved for a request to access data/document
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Requests for specific information should be sent by email.
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Comments
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