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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: IRCT
Last refreshed on: 22 February 2018
Main ID:  IRCT2016111730936N1
Date of registration: 2017-01-27
Prospective Registration: No
Primary sponsor: Vice Chancellor for research and technology of Kurdistan University of Medical Sciences
Public title: The effect of chewing sugar-free gum massage the abdomen and constipation
Scientific title: Comparative study of the effect of abdominal massage, chewing sugar-free gum and a combined method on the incidence and severity of constipation in patients who have undergone lower limb skeletal traction in Sanandaj in Year 1395
Date of first enrolment: 2017-01-20
Target sample size: 124
Recruitment status: Complete
URL:  http://en.irct.ir/trial/24441
Study type:  interventional
Study design:  Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.  
Phase:  N/A
Countries of recruitment
Iran (Islamic Republic of)
Contacts
Name: aram nezakati   
Address:  Besat Hospital, Keshavarz Street 6619616776 Sanandaj Iran (Islamic Republic of)
Telephone: +98 878733285910
Email: aramnezakati20@gmail.comjamal.seidi@yahoo.com jamal.seidi@muk.ac.ir
Affiliation:  Kurdistan University of medical sciences
Name: Jamal Siedi   
Address:  Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj 13446-66177 Sanandaj Iran (Islamic Republic of)
Telephone: +98 87 3182 7464
Email: jamal.seidi@yahoo.com jamal.seidi@muk.ac.ir
Affiliation:  Kurdistan University of Medical Sciences
Key inclusion & exclusion criteria
Inclusion criteria: Inclusion criteria:Not having normal bowel movements and constipation model to study femoral fractures in patients older than 18 years approved by skeletal traction Follow the instructions in the diet based on normal diet without affecting the underlying disease bowel movements(Diabetes, depression, hemorrhoids, Fisher, dementia, multiple sclerosis, Parkinson's disease, a history of abdominal surgery, rheumatoid arthritis, hypothyroidism, spinal cord injury).No special diet or weight loss obesity. Lack of skin inflammation or ulcers in the massage area treated with specific drugs affecting the gastrointestinal tract, bowel movements and not (antacids, anticholinergic and anti-Parkinson's medications are, calcium channel blockers, diuretics, iron supplements, anti-inflammatory drugs NSAIDs, and opioid consumption).Lack of inflammatory bowel disease. No smoking and drugs.Exclusion criteria from the study:Not wanting to continue cooperation.Before the patient is discharged 7 days.The use of drugs affecting bowel function such as lactulose, magnesium hydroxide syrup and ...Inability to chew gum
Exclusion criteria:

Age minimum: 18 years
Age maximum: no limit
Gender: Male
Health Condition(s) or Problem(s) studied
constipation.
constipation
constipation
Intervention(s)
For patients (2) clockwise abdominal massage for 15 minutes per hour of 9 am and 9 pm with gentle constant pressure with two or three fingers in a clockwise direction to rotate the area of the anterior superior iliac spine straight day + care routine will be performed by the principal investigator.
For patients (3) a combination of chewing sugar-free gum a number Barbd Mark van an hour-a-day eating meals (breakfast, lunch, dinner) for half an hour and massage the abdomen in a clockwise direction for 15 minutes on the clock in the direction transverse colon and descending colon in the left upper abdomen in the direction of the anterior superior iliac spine down the left Without prejudice to patient privacy for 7 days + care routine will be performed by the principal investigator.
For patients (1) chewing sugar-free gum a number Mark van (25-gram package containing xylitol) 3 times a day for 30 minutes after an hour of eating every meal + routine hospital for 7 days prescribed by Research Associate and monitored.
Intervention 1: For patients (3) a combination of chewing sugar-free gum a number Barbd Mark van an hour-a-day eating meals (breakfast, lunch, dinner) for half an hour and massage the abdomen in a clockwise direction for 15 minutes on the clock in the direction transverse colon and descending colon in the left upper abdomen in the direction of the anterior superior iliac spine down the left Without prejudice to patient privacy for 7 days + care routine will be performed by the principal investigator. Intervention 2: To control (4) routine actions, such as recommendations to increase fluid intake, fiber intake, and active and passive movements in bed is recommended. Intervention 3: For patients (2) clockwise abdominal massage for 15 minutes per hour of 9 am and 9 pm with gentle constant pressure with two or three fingers in a clockwise direction to rotate the area of the anterior superior iliac spine straight day + care routine will be performed by the principal investigator. Intervention 4: For patients (1) chewing sugar-free gum a number Mark van (25-gram package containing xylitol) 3 times a day for 30 minutes after an hour of eating every meal + routine hospital for 7 days prescribed by Research Associate and monitored.
To control (4) routine actions, such as recommendations to increase fluid intake, fiber intake, and active and passive movements in bed is recommended.
Prevention
Primary Outcome(s)
The incidence of constipation. Timepoint: 7 days after the intervention. Method of measurement: questionnaire ROM III.
Constipation severity. Timepoint: 7 days after the intervention. Method of measurement: questionnaire ROM III.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Vice Chancellor for research and technology of Kurdistan University of Medical Sciences
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Kurdistan University of Medical Sciences
Results
Results available:
Date Posted:
Date Completed:
URL:
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