Objectives: Effect of acupressure on nausea and vomiting in patients undergoing hemodialysis.
Design: Single blinded clinical trial.
Setting and conduct: The intervention is carried out with in one group in three stages including routine care, applying acupressure, and placebo. Acupressure is performed by Sea-Band as an elastic band with a plastic button in its below. It is considered to be some sort of acupressure when the Sea-Band button is placed on the P6 point (Nei guan) on the inner surface of the forearm. On the other hand, it will be considered to have a placebo effect, when the Sea-Band button is placed on the opposite of P6 (Nei guan) on the back of the forearm. The routine treatment is consisted of routine interventions in the dialysis ward.
Participants: Inclusion criteria are: (1) being alert; (2) not taking antiemetic drugs at least six hours before hemodialysis; (3) beginning of hemodialysis at least three months before the study; (4) being over 20 years old; (5) having no skin problem such as allergies and ulcers at the Sea-Band site; (6) being depended on three cycles of hemodialysis per week.
Exclusion criteria are: (1) having a low level of consciousness, (2) being transfered to other centers during the study (3) requiring emergency hemodialysis; (4) taking a long journey by car just before hemodialysis ;(5) having acute gastrointestinal illnesses; (6) having pain or severe anxiety; (7) having motion sickness.
Intervention: Interventions including routine care, applying acupressure, and placebo that is done in three stages.
Main outcome measures (variables): Severity of nausea and vomiting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304298717N2
Registration date:2014-01-20, 1392/10/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-20, 1392/10/30
Registrant information
Name
Mohammad Reza Asgari
Name of organization / entity
Semnan University of Medical Sciences and Health and Treatment Services
Country
Iran (Islamic Republic of)
Phone
+98 23 1445 3365
Email address
asgari@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on severity of nausea and vomiting during hemodialysis in hemodialysis patients
Public title
The effect of acupressure on prevention of nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria are: (1) being alert; (2) not taking antiemetic drugs at least six hours before hemodialysis; (3) beginning of hemodialysis at least three months before the study; (4) being over 20 years old; (5) having no skin problem such as allergies and ulcers at the Sea-Band site; (6) being depended on three cycles of hemodialysis per week.
Exclusion criteria are: (1) having a low level of consciousness, (2) being transfered to other centers during the study (3) requiring emergency hemodialysis; (4) taking a long journey by car just before hemodialysis ;(5) having acute gastrointestinal illnesses; (6) having pain or severe anxiety; (7) having motion sickness.
Age
From 20 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study is single blinded so that patients do not know anything about the type of the intervention (acupressure or placebo). Also in this study, placebo is used, so that when the Sea-Band button is placed on the opposite site of P6 (Nei guan) on the back of the forearm, it has the placebo role. When the Sea-Band button is placed on the point P6 (Nei guan) in the inner surface of the forearm, it has the acupressure role.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of semnan university of Medical Sciences
Street address
Semnan University of Medical Sciences, Semnan, Semnan Province, Iran
City
Semnan
Postal code
3519899951
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
372055/92
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Severity of vomiting
Timepoint
At the end of hemodialysis, after removing hemodialysis needles and dressing of vascular access site
Method of measurement
korttila vomiting severity scale
2
Description
Severity of nausea
Timepoint
At the end of hemodialysis, after removing hemodialysis needles and dressing of vascular access site
Method of measurement
Verbal Numeric Rating Scale (VNRS)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention (Routine care): In the control group patients receive routine care, that is consisted of normal saline (200 ml) after nausea and vomiting. After removing hemodialysis needles and dressing of vascular access site, a nurse measures the severity of nausea and vomiting during hemodialysis by using verbal numerical rating scale (VNRS) and korttila vomiting severity scale.
Category
Treatment - Other
2
Description
The second intervention (use of acupressure): In the intervention group, 10 minutes before inserting hemodialysis needles, the Sea-Band is closed on patients’ wrists so that its button is placed on the P6 point (Nei guan) on the inner surface of the forearm, about 2 inches (three fingers width) above the Internal groove of wrist. The Sea-Band remains during hemodialysis and is removed at the end of hemodialysis just before removing hemodialysis needles. After removing hemodialysis needles and dressing of vascular access site, a nurse measures the severity of nausea and vomiting during hemodialysis by using verbal numerical rating scale (VNRS) and korttila vomiting severity scale.
Category
Treatment - Devices
3
Description
The third intervention (use of placebo): In the intervention group, using placebo, 10 minutes before entering the hemodialysis needles, the Sea-Band is closed on patients’ wrists so that its button is placed on opposite of P6 point (Nei guan) on the back of the forearm. The Sea-Band during hemodialysis remains and is removed at the end of hemodialysis just before removing hemodialysis needles. After removing hemodialysis needles and dressing of vascular access site, a nurse measures the severity of nausea and vomiting during hemodialysis by using verbal numerical rating scale (VNRS) and korttila vomiting severity scale.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis ward of Semnan Kowsar hospital
Full name of responsible person
Mohammad Reza Asgari
Street address
Department of dialysis, Kowsar hospital, Basij Boulevard, Semnan, Iran
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr. Raheb Ghorbani
Street address
Research and Technology Deputy of Semnan University of Medical Sciences, Basij Boulevard, Semnan, Iran
City
Semnan
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, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Asgari
Position
PhD in nursing - Faculty member
Other areas of specialty/work
Street address
Faculty of nursing and allied, Semnan University of Medical Sciences, Semnan, Iran
City
Semnan
Postal code
3514743365
Phone
+98 23 1445 3365
Fax
+98 23 1335 4191
Email
asgari5000@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
ِDr. Mohammad Reza Asgari
Position
PhD in nursing - Faculty member
Other areas of specialty/work
Street address
Faculty of nursing and allied, Semnan University of Medical Sciences, Semnan, Iran
City
Semnan
Postal code
3514743365
Phone
+98 23 1445 3365
Fax
+98 23 1335 4191
Email
asgari5000@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Asgari
Position
PhD in nursing - Faculty member
Other areas of specialty/work
Street address
Faculty of nursing and allied, Semnan University of Medical Sciences, Semnan, Iran
City
Semnan
Postal code
3514743365
Phone
+98 23 1445 3365
Fax
+98 23 1335 4191
Email
asgari5000@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)