Survey the effect of Anti-Constipation Belt on patients with chronic constipation
Objectives: Abdominal massage is a common and effective treatment to control constipation. Regarding the specific needed method of this treatment, we need a trained and professional operator for that. The main aim of anti-constipation belt designing is removing the operator from this treatment process.
Design: This single-blind clinical trial evaluates the therapeutic effects of this device on patients with chronic constipation.
Setting and conduct: 30 people in both gender with necessary conditions randomly will be divided in two 15 membered groups: intervention and control. The members of control group will receive osmotic laxatives during this study but in intervention group, the members will be treated by massage with anti-constipation belt in addition to osmotic laxative. Massage therapy is about 8 sessions in average every 3.5 days. Every session will take about 20 minutes. the GSRS ( Gastrointestinal Symptoms Rating Scale) questionnaire will be filled For every patient to follow their symptoms improvement in 1st and 4th and 8th visits in both group. In intervention group there is one more questionnaire that will filled in one month after the end of the massage besides to those 3 questionnaires.
Major Inclusion and Exclusion criteria: The inclusion criteria will be constipated in accordance with RomeII criteria and dependent on laxatives and exclusion criteria will consisted of known intestinal cancer, recently undergone abdominal surgery, pregnancy and diabetes and etc.
Intervention: Massage with Anti-Constipation Belt in patient with chronic constipation
Main outcome measures (variables) : The improvement in their symptoms will be based on GSRS questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102719707N1
Registration date:2014-11-23, 1393/09/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-23, 1393/09/02
Registrant information
Name
Delaram Nahid
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4404 7077
Email address
delaramnahid@yahoo.com
Recruitment status
Recruitment complete
Funding source
Roshd department, Vice Chancellor for Research, Qazvin University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of Anti-Constipation Belt on patients with chronic constipation
Public title
Effect of Anti-Constipation Belt on patients with chronic constipation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Constipation in accordance with RomeII criteria; constipation dependent on laxatives.
Exclusion criteria: Known intestinal cancer; recently undergone abdominal surgery ( 6 month ago) ; pregnancy; dementia diagnosis; diabetes; hypothyroidism; cardiovascular and cerebrovascular disease; major depression disorder; abdominal hernia; severe back pain.
Age
From 20 years old to 80 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization method between control and intervention group is based on the time of their 1st visit. It means that in first month, all of the qualified patients categorize in intervention group, then other patients in their 1st visit categorize in control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard,
City
Qazvin,
Postal code
Approval date
2014-07-22, 1393/04/31
Ethics committee reference number
28/20/8994
Health conditions studied
1
Description of health condition studied
chronic constipation
ICD-10 code
K92.9
ICD-10 code description
Disease of digestive system, unspecified
Primary outcomes
1
Description
constipation
Timepoint
1st and 4th and 8th visits during the massage session and a month after last session
Method of measurement
GSRS questionnaire ( before, during and after of the massage session )
Secondary outcomes
1
Description
Diarrhea
Timepoint
1st and 4th and 8th visits during the massage session and a month after last session
Method of measurement
GSRS questonnaire ( before, during and after the massage session )
2
Description
Bloated Abdomen
Timepoint
1st and 4th and 8th visits during the massage session and a month after last session
Method of measurement
GSRS questonnaire ( before, during and after the massage session )
3
Description
Gas Passage
Timepoint
1st and 4th and 8th visits during the massage session and a month after last session
Method of measurement
GSRS questonnaire ( before, during and after the massage session )
4
Description
Incompelete Defecation
Timepoint
1st and 4th and 8th visits during the massage session and a month after last session
Method of measurement
GSRS questonnaire ( before, during and after the massage session )
5
Description
Hard stools defecation
Timepoint
1st and 4th and 8th visits during the massage session and a month after last session
Method of measurement
GSRS questonnaire ( before, during and after the massage session )
6
Description
Loose stools defecation
Timepoint
1st and 4th and 8th visits during the massage session and a month after last session
Method of measurement
GSRS questonnaire ( before, during and after the massage session )
Intervention groups
1
Description
intervention group, members will be treated by massage with Anti-Constipation belt in addition to osmotic laxative. Massage therapy is about 8 sessions in average every 3.5 days. Every session will take about 20 minutes.The GSRS ( gasterointestinal symptoms rating scale) questionnaire will be filled For every patient to follow their symptoms improvement in the 1st and 4th and 8th visits during the massage sessions and one month after the end of the massage.
Category
Treatment - Other
2
Description
members of control group only will receive osmotic laxatives during this study and the GSRS (gasterointestinal symptoms rating scale) questionnaire will be filled for every patient to follow their symptoms improvement in 1st visit and then in 4th week and 8th week.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali-sina Hospital
Full name of responsible person
Dr Arash Miroliaee
Street address
Bouali-sina Hospital, Bouali-sina Street,
City
Qazvin,
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpour
Street address
Shahid Bahonar Boulevard,
City
Qazvin,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Arash Miroliaee
Position
Specialist in Gasteroenterology and Hepatology, Professor
Other areas of specialty/work
Street address
Bouali-sina Hospital, Bouali-sina Street,
City
Qazvin,
Postal code
Phone
+98 28 3333 2930
Fax
Email
arash_mir53@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Delaram Nahid
Position
Medical student
Other areas of specialty/work
Street address
Shahid Bahonar Boulevard,
City
Qazvin,
Postal code
Phone
+98 912 238 2160
Fax
Email
delaramnahid@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Delaram Nahid
Position
Medical student
Other areas of specialty/work
Street address
Shahid Bahonar boulevard,
City
Qazvin,
Postal code
Phone
00
Fax
Email
delaramnahid@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)