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IRCT2014102719707N1 IRCT 2014-11-23 Vice Chancellor for Research, Qazvin University of Medical Sciences Effect of Anti-Constipation Belt on patients with chronic constipation Survey the effect of Anti-Constipation Belt on patients with chronic constipation 2014-07-23 anticipated 30 Complete https://irct.ir/trial/17559 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. 0 (exploratory trials) chronic constipation. Intervention 1: 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. Intervention 2: 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.
public Dr. Arash Miroliaee
Bouali-sina Hospital, Bouali-sina Street,
Qazvin, Iran (Islamic Republic of) +98 28 3333 2930 arash_mir53@yahoo.com Qazvin University of Medical Sciences scientific Delaram Nahid
Shahid Bahonar Boulevard,
Qazvin, Iran (Islamic Republic of) +98 912 238 2160 delaramnahid@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) 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. 20 years 80 years Both K92.9 Disease of digestive system, unspecified Treatment - Other Other 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. 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. 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 ). 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 ). 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 ). 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 ). 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 ). 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 ). 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 ). Vice Chancellor for Research, Qazvin University of Medical Sciences Approved 2014-07-22 Ethics Committee of Qazvin University of Medical Sciences Shahid Bahonar Boulevard, Qazvin, Iran (Islamic Republic of)