Effect of pressure on pericardium 6 (point P6) on the rate of nausea in post Cataract surgery in elderly patients
Design
In this study, 100 elderly patients according to inclusion and exclusion criteria who are admitted to Cataract surgery are randomly assigned to the test and control group.
Settings and conduct
The location of this study is Khalili hospital in Shiraz. Before the operation, for patients in the test group, for one hour, a bracelet containing a balloon ball in the wrist should be closed. After induction of anesthesia, the bracelet was opened and at 8, 12 hours after the operation, the frequency and severity of nausea (0 to 10 Score) are recorded in the questionnaire.
Participants/Inclusion and exclusion criteria
Elderly patients undergo a general anesthetic Cataract surgery without a history of congenital heart disease, severe pulmonary disease, chronic digestive diseases, malignancies, vomiting during previous operations and the use of anesthetic drugs at least 12 hours before surgery.
Intervention groups
For the test group, the pressure on the point (P6) of the wrist is applied by a special bracelet containing a balloon ball.
The control group closes the bracelet without a balloon ball.
Main outcome variables
Incidence and severity of nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170523034093N1
Registration date:2017-12-26, 1396/10/05
Registration timing:retrospective
Last update:2017-12-26, 1396/10/05
Update count:0
Registration date
2017-12-26, 1396/10/05
Registrant information
Name
Mohammad Amin Pishbin
Name of organization / entity
Yazd university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
amin-pishbin@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yazd University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pressure on pericardium 6 (point P6) on the rate of nausea in post Cataract surgery in elderly patients
Public title
Effect of acupressure on the rate of nausea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The elderly patients (over 60 years of old);
Cataract surgery with general anesthesia.
Exclusion criteria:
History of congenital heart disease
History of severe pulmonary disease
History of chronic diseases of the gastrointestinal tract
History of malignancies
Vomiting during previous surgeries
Postoperative vomiting
Use of anesthetic drugs at least 12 hours before surgery
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using Random Numbers Table
Blinding (investigator's opinion)
Not blinded
Blinding description
Data analysis is done by an individual who does not know about assigning a patient to a test or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Central Bulding of Shahid Sadoughi University of Medical sciences, Shahid Bahonar Sq, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.SSU.REC.1395.240
Health conditions studied
1
Description of health condition studied
Number and severity of post operation nausea
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea
Timepoint
Immediately,eight hours and twelve hours
Method of measurement
See the nurse questions from patients and their relatives zero to ten
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group - A bracelet that is an orb to pressure it is closed at the desired location (P6) one hour before surgery. After the induction of general anesthesia, the bracelet will be opened.
Category
Treatment - Other
2
Description
Control group - The same bracelet is closed at the desired location (P6) one hour before surgery. After the induction of general anesthesia, the bracelet will be opened.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Khalili hospital
Full name of responsible person
Mohammad Amin Pishbin
Street address
Khalili hospital and Medical Education Center, Khalili St,Shiraz.
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
Email
aminpishbin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Dr. Hooshang Mehrparvar
Street address
Center Building of University, Bahonar Sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
ah.mehrparvar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences, Yazd
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
Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Dr. Hossein Tavangar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Bu Ali St., Timsar Fallahi Ave., Safaeyeh
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Fax
Email
tavangar11@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences , School of Nursing & Midwifery
Full name of responsible person
Dr.HosseinTavangar
Position
Associatet Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Bu Ali St., Timsar Fallahi Ave., Safaeyeh
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
tavangar11@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mohammad Amin Pishbin
Position
MSc. student of Geriatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Bu Ali St., Timsar Falahi Ave., Safaeyeh
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
aminpishbin@yahoo.com
Web page address
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
Not applicable
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