Compare of acupressure and pressure on false points on constipation of patients with chronic renal failure undergoing hemodialysis in control and intervention groups
Objectives: One of the most common digestive problem in patients undergoing hemodialysis is chronic constipation. With regard to the effect of acupressure on constipation of patients with chronic renal failure undergoing hemodialysis have not done in any studies in Iran; this study is doing for the effect of acupressure on constipation of these patients.
Design: This study is a double-blind randomized clinical trial so that patients and researchers (collectors of questionnaires) will be blind about allocation of patients to control and intervention groups.
Setting and conduct: The sample includes 60 patients with constipation undergoing hemodialysis in hospitals of Noshar, Chalus and Noor cities in Mazandaran province in Iran. They will be allocated alternately in control and intervention groups by permutation blocks with four blocks. Improving of constipation by increasing of number of defecation and improving of stool quality (based on Bristol criteria) will be measured. In intervention group, acupressure will be performed during hemodialysis for 4 weeks at 3 times in week and each time for 1 minute in points of acupressure. These points include: three knuckles from middle of abdomen in both sides of umbilicus, between the index finger and thumb in hands, between first and second finger in feet, down and outer of knees and two fingers below of umbilicus. In Control group, pressure will be performed in false points. Improving of constipation will be determined by increasing number of daily defecation and improving of stool quality (with Bristol criteria) before and after intervention. For analyzing of finding, descriptive and inferential statistics will be used. Significant level will be considered less than 0.05.
Intervention: Doing pressure on acupressure points in intervention group and pressure on false points on control group
Main outcome Measures: Number of daily defecation and quality of stool
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015043022027N1
Registration date:2015-07-28, 1394/05/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-28, 1394/05/06
Registrant information
Name
Mohammad Mojalli
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3722 5027
Email address
mojalli.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare of acupressure and pressure on false points on constipation of patients with chronic renal failure undergoing hemodialysis in control and intervention groups
Public title
Effect of acupressure on constipation of hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Having constipation based on Rom 3 criteria (having 2 criterion from 6 criterion of constipation); having at least 6 months of hemodialysis; having dossier in dialysis unit; having hemodialysis 3 times and every times 4 hours in weeks; having full consciousness and ability of hearing and speaking; not having skin disease, progressive heart failure or stroke based on claim of patients; not having amputation or an ulcer at the site of acupressure; not using from laxatives in recently month; not having digestive disorders such as irritable bowel syndromes based on claim of patient, history and physical examination.
Exclusion Criteria:
Disrupting or failure to completing the study because of transition to acute care unit; death, traveling or having transplantation surgery; stressful life event such as death of relatives; unwillingness to continue the study.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Gonabad University of Medical Sciences
Street address
Next to the Asian Road
City
Gonabad
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
Gmu.Rec.1392.53
Health conditions studied
1
Description of health condition studied
Chronic Renal failure
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
daily defecation
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Daily number of defecation
2
Description
Quality of stool
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
compare of shape of stool with pictures of stool (based on Bristol criterion)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Doing acupressure on false points
Category
Other
2
Description
Intervention group: Doing acupressure 3 times and each times for 1 minute in points of acupressure: three knuckle from midline of abdomen in both sides of umbilicus, between the index finger and thumb in hands, between first and second finger in feet, down and outer of knees and two fingers below the umbilicus
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Street address
City
Chalus
2
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Street address
City
Noor
3
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Street address
City
Noshahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Gonabad University of Medical Sciences
Full name of responsible person
Ali Mohammad pour
Street address
Next to the Asian Road, Gonabad University of Medical Sciences
City
Gonabad
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 of Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Mojalli
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Next to the Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
Mojalli.m@gmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Mojalli
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Next to the Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
Mojalli.m@gmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Mojalli
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Next to the Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
Mojalli.m@gmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)