The evaluation of acupressure effects in PC6 point on postoperative nausea and vomiting severity and episodes in patients undergoing general surgeries with spinal anesthesia
The aim of the study was to evaluate acupressure effects in PC6 point on the severity and episodes of nausea and vomiting in patients of the patients undergoing general surgeries with spinal anesthesia. The subjects would be assigned to 2 groups; intervention and control groups. This study is one-tale blind pilot trial would be performed on 70 patients. In this study,a 10-cm ruler was used to measure the nausea severity after applying special wristband of acupressure branded with C-Band. The severity of nausea would be marked by the patient from zero to ten. As for psychic sense of nausea episodes, the self-report is an appropriate tool to measure it. To assay the vomiting episodes is utilized and ultimately the effects of acupressure on the aforementioned point would be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061134475N1
Registration date:2017-10-31, 1396/08/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-31, 1396/08/09
Registrant information
Name
Isan Darvishi
Name of organization / entity
Shiraz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 31452339995
Email address
i_darvishi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of acupressure effects in PC6 point on postoperative nausea and vomiting severity and episodes in patients undergoing general surgeries with spinal anesthesia
Public title
Effect of acupressure on nausea and vomiting decrease
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria: male and female patients aged from 15 to 60 years old; patients undergone general surgeries with spinal anesthesia; passing at least 3 hours after the injection of an analgesic; not taking antimetic medications; not smoking (in accordance with the patient's statement); lack of edema; disease; and skin inflammation on the massage area (lake of peeling discomfort such as eczema and shallow infection of skin considered as acupressure limitations); before enrolling in the study; not using other procedures to control nausea and vomiting. The exclusion criteria: complicated surgery in terms of infection and severe pain (if the patient complaints of severe pain; he or she has revived analgesic and recorded in the study and would be carried out through face scale pain.); patients with carpal tunnel syndrome; patient with obesity; motion sickness; and history of nausea and vomiting in 24 hours ago; lack of cooperation in every unit of the study.
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The sampling method would be on random,then the patients would randomly be assigned to 2 groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street,Shiraz
City
Shiraz
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.SUMS.6396.31
Health conditions studied
1
Description of health condition studied
Nausea and Vomiting
ICD-10 code
K91.0
ICD-10 code description
Following Gastrointestinal Surgery
Primary outcomes
1
Description
Nausea and Vomiting
Timepoint
1 hour, 3hour and 7 hours after the surgery
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
In the trial group:
The special acupressure wristband with pressing buttons would be applied on both wrists in PC6 point at 4 stages as the following: during the surgery, 1, 3 and 7 hour(s) after the surgery, respectively. The accuracy of applying wristbands in the aforementioned areas in the view of blood flow would be proved through surveying of radial pulse. The wristband would be kept in the desired location for 7 hours, it would be reaplied every 10 minutes for 2 hours if the patient complains of uncomfortability.
Category
Other
2
Description
In the control group:
A wristband without any pressing buttons would loosely be applied on both wrists in PC6 point at 4 stages as the following: during the surgery, 1, 3, and 7 hour(s) after the surgery, respectively. The accuracy of applying the wristbands in the aforementioned areas in the view of blood flow would be proved through surveying of radial pulse. The wristband would be left in the desired location for 7 hours, it would be reapplied every 10 minutes for 2 hours if the patient complains of uncomfortability.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital, Isfahan
Full name of responsible person
Jamshid Eslami
Street address
Namazi Square, Shiraz
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Reserch Shiraz University of Medical Sciences
Full name of responsible person
Dr.Seid Basir Hashemi
Street address
Namazi Square, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Reserch Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Isan Darvishi
Position
Master Student Operating Room
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Postal code
7134814336
Phone
+98 31 4523 3995
Fax
+90 7132359317
Email
i_darvishi@sums.ac.ir
Web page address
sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Jamshid Eslami
Position
phD in Curiculum
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 713647425058
Fax
Email
eslamij@sums.ac.ir
Web page address
sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Isan Darvishi
Position
Master Student Operating Room
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 713647425058
Fax
Email
i_darvishi@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)