Protocol summary

Summary
This was a double blind randomized trial on 60 patients undergoing Strabismus surgery, in Farabi super specialty eye hospital. After taking informed consent, eligible patients were randomly assigned into intervention or placebo groups. The intervention group took acupressure from half an hour before induction of anesthesia until 6 hours after the surgery. Acupressure was applied by sea-band with button on the P6 point. In the placebo group, the sea-band was placed in the opposite position of patient's wrist. The Patients were studied in the recovery room and 6 hours after the surgery by another person who was not informed of the intervention, in terms of nausea and vomiting, by using VAS and vomiting questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102014853N1
Registration date: 2011-05-20, 1390/02/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-05-20, 1390/02/30
Registrant information
Name
Zahra Alizadeh
Name of organization / entity
Faculty of Nursig and Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5568 6595
Email address
nikbakht@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2009-12-28, 1388/10/07
Expected recruitment end date
2010-01-27, 1388/11/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effectiveness of acupressure on P6 on reduction of postoperative nausea and vomiting in patients undergoing strabismus surgery
Public title
Effectiveness of acupressure on reduction of nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 12- 65 years old, undergoing general anesthesia with endotracheal intubation, undergoing strabismus surgery, no previous history of gastrointestinal disorders, no travel disease or motion sickness Exclusion criteria: unusual problems during the surgery, Unwillingness to use handcuffs at any point of the study, sensitivity to the sea-band
Age
From 12 years old to 65 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
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-chancellor for research, Tehran University of Medical Sciences
Street address
6th floor, Central building of the university, corner of Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2010-12-19, 1389/09/28
Ethics committee reference number
1164/ 130/ د/ 89

Health conditions studied

1

Description of health condition studied
Strabismus
ICD-10 code
H50.9
ICD-10 code description
Strabismus, unspecified

Primary outcomes

1

Description
nausea
Timepoint
6 hours after surgery
Method of measurement
visual analogue scale

2

Description
vomiting
Timepoint
6 hours after surgery
Method of measurement
4 points likert scale

Secondary outcomes

empty

Intervention groups

1

Description
Control group: the sea-band was placed in the opposite position of patient's wrist, half an hour before induction of anesthesia to 6 hours after surgery
Category
Prevention

2

Description
Intervention group: acupressure was applied by sea-band; buttons was placed on the P6 point, half an hour before induction of anesthesia to 6 hours after surgery
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Eye Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
6th floor, Central building of the university, corner of Ghods St., Keshavarz Blvd.
City
Tehran
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, Tehran 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
Faculty of Nursing and Midwifery, Tehran University of Medical Scinces
Full name of responsible person
Zahra Alizadeh
Position
Master of nursing
Other areas of specialty/work
Street address
Nosrat st ,Tohid sq
City
Tehran
Postal code
Phone
+98 21 5568 6595
Fax
Email
alizadeh_z10@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery ,Tehran University of Medical Sciences
Full name of responsible person
Dr Alireza Nikbaht Nasrabadi
Position
Associate Professor
Other areas of specialty/work
Street address
Nosrat st, Tohid sq
City
Tehran
Postal code
Phone
+98 21 6642 7255
Fax
Email
nikbakht@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing andMidwifery, Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Master of nursing
Other areas of specialty/work
Street address
Nosrat st,Tohid sq
City
Tehran
Postal code
Phone
Fax
Email
alizadeh_z10@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...