Determining the effect of Auriculotherapy on the severity of constipation in patients undergoing hemodialysis
Design
This study is a single blind clinical trial performed in a time period of four months with two groups and three stages (before, immediately and one month after intervention) in four hemodialysis centers of Isfahan in Iran in 2018.Seventy patients are selected randomly and the subjects will be randomly assigned to two groups of 35 subjects.
Settings and conduct
Hemodialysis centers of Alzahra, Noor , Amin and Farabi Hospitals. The method of doing the study: the patients will be divided into two groups: intervention and control. In the intervention group, the intended points in the ears of the patients are stimulated by vaccaria seed. In the control group, adhesive, without vaccaria seed, will be located in the false points during a period of 10 sessions.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Aged between 18 and 65 years old, having a history of constipation with the score of 1 and above according to the constipation assessment scale; undergoing dialysis three times a week and four hours each time; having at least six months of hemodialysis in advance
Exclusion Criteria: Using anti-constipation drugs; skin disease; localized infections and lesion in the ear; having a history of advanced heart failure and stroke;the existence of electrical device in the body.
Intervention groups
Intervention group: For 10 sessions, vaccaria seeds will be located in the specific points in ears.
Control group: Non-vaccaria seeds will be placed, like the intervention group, but on the false points in ears.
Main outcome variables
The severity of constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190319043091N1
Registration date:2019-05-19, 1398/02/29
Registration timing:retrospective
Last update:2019-05-19, 1398/02/29
Update count:0
Registration date
2019-05-19, 1398/02/29
Registrant information
Name
Houri Lahijanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3266 8042
Email address
h.lahijanian@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-24, 1397/02/04
Expected recruitment end date
2018-06-25, 1397/04/04
Actual recruitment start date
2018-05-10, 1397/02/20
Actual recruitment end date
2018-08-11, 1397/05/20
Trial completion date
2018-08-11, 1397/05/20
Scientific title
The Effect of Auriculotherapy on the Severity of Constipation in Patients Undergoing Hemodialysis
Public title
The Effect of Auriculotherapy on the Severity of Constipation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years
Having a history of constipation based on the scale of constipation scored 1 and more.
Doing dialysis three times a week and four hours each time
Having at least six months of hemodialysis in advance
Having fix and active cases/records in the hemodialysis department of the intended center
Exclusion criteria:
The use of anti-constipation drugs
Having skin disease, localized infections and lesion in the ear
Having a history of advanced heart failure and stroke
The use of electrical device in the body of the patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Based on a randomized allocation, 35 pockets include the term "control group" and 35 pockets the term "intervention group" and, then, the clients are asked to choose one pocket among these 70 ones. It should be noted that each pocket that is taken by individuals is returned to the packets so that all individuals can have equal chance in choosing the pockets.
Blinding (investigator's opinion)
Single blinded
Blinding description
Both ears of all subjects of each group were glued, while the subjects were not informed of the main and false points.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar Jereyb St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746734461
Approval date
2017-12-24, 1396/10/03
Ethics committee reference number
IR.MUI.REC.1396.3.618
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Severity of constipation
Timepoint
The beginning of the study (before the start of the study) immediately after the intervention and one month after the end of the intervention
Method of measurement
The constipation assessment scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For 10 sessions with three days interval (30 days in total), vaccaria seeds will be located in the points of constipation, large intestine and rectum of the right ear, and shen men and kidney in the left ear; the seeds will be removed by the researcher every 3-days in face-to-face meetings and at least 1-2 hours later, another vaccaria seed will be located on the same point. The patients are instructed to press the seeds 8 times a day for one minute each time.
Category
Treatment - Devices
2
Description
Control group:For 10 sessions with three days interval (30 days in total), non-vaccaria seeds will be located on the false points of both ears. The seeds will be removed by the researcher and her colleague every 3-days in face-to-face meetings and at least 1-2 hours later, another non-vaccaria seed will be located on the same point.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Houri Lahijanian
Street address
Alzahra hospital., Blvd Sofeh
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
h.lahijanian@nm.mui.ac.ir
2
Recruitment center
Name of recruitment center
Noor and Ali Asghar hospital
Full name of responsible person
Houri Lahijanian
Street address
Noor and Ali Asghar hospital,. Blvd Hasht behesht
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2127
Email
h.lahijanian@nm.mui.ac.ir
3
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Houri Lahijanian
Street address
Amin hospital.,Ebne Sina Ave
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3445 5052
Email
h.lahijanian@nm.mui.ac.ir
4
Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Houri Lahijanian
Street address
Farabi hospital., Blvd Arghavanieh
City
Isfahan
Province
Isfehan
Postal code
8155113153
Phone
+98 31 3531 2020
Email
h.lahijanian@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nahid Shahgholian
Street address
Hezar Jereyb St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7565
Email
shahgholian@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Houri Lahijanian
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar Jereyb St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8155113153
Phone
+98 31 3531 2020
Email
h.lahijanian@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nahid Shahgholian
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar Jereyb St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7565
Email
shahgholian@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Houri Lahijanian
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar Jereyb St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8155113153
Phone
+98 31 3531 2020
Email
h.lahijanian@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available