Background and Aim:
Nausea and vomiting are the most common side effects of Laparoscopic Cholecystectomy y. The aim
of the current study was to assess the effect of ice massage applied to the pericardium 6 (P6 or Neigaun)
Acupuncture point on nausea– vomiting due to Laparoscopic Cholecystectomy of patient in general surgery ward.
Materials and Methods: In a randomized clinical trial oneblind, 90 patients were randomly divided into three groups. Ice massage group were massaged gently on the skin around P6 point of the hand with ice cube into a wet gauze pad for 7 minutes twice a day with 12- hours interval for 24 hours by the patient. Placebo group were massaged with wooden cube and the control group received no interventions. Nausea and vomiting in three groups rated by Nausea and Emesis Questionnaire in 4
periods of time in 24 hours was used for the assessment of nausea and vomiting. The data will be analyzed with SPSS 16 software and the results will compare with Parametric and non parametric tests.
Keywords: Nausea, Vomiting, Laparoscopic Cholecystectomy, Acupressure, Massage
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111625074N1
Registration date:2016-01-17, 1394/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Mohamad Mahboobnia
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3838 5137
Email address
m.mahbubnia@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of P6 Point ice massage on Postoperative nausea and vomiting of Laparoscopic Cholecystectomy patients
Public title
effect of ice massage on post operation nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having an ASA classification score of 1 OR 2; having 16-60 years of old; not addiction; not pregnant; not disabled or not having Wrist disorder in p6 point; not having bowel instruction or other gastrointestinal disorders; not having nausea or vomiting before operation; no anti-emetic drug usage in 24 hours before operation; patient with general anesthesia;
Exclusion criteria: the length of operation less than 90 minutes; more than 60 and less than 16 years of old; having an ASA classification score of 3,4 or 5; pregnant women; unwillingness to study continue
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
N.2, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Postal code
6715847141
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
KUMS.REC.1394.162
Health conditions studied
1
Description of health condition studied
Cholecystitis
ICD-10 code
k81
ICD-10 code description
Cholecystitis
Primary outcomes
1
Description
post operation nausea and vomiting
Timepoint
After intervention and in 6 hours interval for 24 hours after operation
Method of measurement
Standard Questionaire and VAS
Secondary outcomes
1
Description
damage and pressure on wrist's nerve
Timepoint
12 hours after intervention
Method of measurement
Sensory and motor examination
Intervention groups
1
Description
Intervention group: ice pack massage with 2*2*2* dimension for 7 minutes on p6 point just after operation and 12 hours later.
Category
Other
2
Description
Control group: no intervention
Category
Other
3
Description
Placebo group: wooden pack massage with 2*2*2 dimension for 7 minutes on P6 point just after operation and 12 hours later
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah Emam Reza Hospital
Full name of responsible person
mohammad mahbobnia
Street address
Kermanshah University of Medical Science
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fateme Hadadian
Street address
N.2, Shahi Beheshti blvd, Kermanshah University of Medical Science
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical sciences
Full name of responsible person
Mohamad Mahboobnia
Position
Student
Other areas of specialty/work
Street address
18th No. 20th Block Mehrabi Shahrak Elahie
City
Kermanshah
Postal code
Phone
+98 83 3838 5137
Fax
Email
m.mahbubnia@kums.ac.irmahboob535353@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical sciences
Full name of responsible person
Mohamad Mahboobnia
Position
M.Sc Student
Other areas of specialty/work
Street address
No 18, 20th Block Shahrak Mehrabi Elahie
City
Kermanshah
Postal code
Phone
+98 83 3838 5137
Fax
Email
mahboob535353@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Mohamad Mahboobnia
Position
student of MSc
Other areas of specialty/work
Street address
N.2, Shanid Beheshti BLVD, KUMS, Kermanshah
City
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 4444
Fax
+98 918 387 4731
Email
mahboob535353@gmail.com
Web page address
http://www.kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)