We are going to asses the effect of foot reflexology on nausea and vomiting of patients undergoing laparoscopic cholecystectomy. Inclusion criteria: patients undergoing laparoscopic cholecystectomy, people aged between 20-60 years, no history of gastrointestinal disorders such as gastritis, preoperative reflux and exclusion criteria were: lead laparoscopy to laparotomy, during a drag operation over 2 hours of surgery, anesthesia drugs outside the prescribed protocol, patients with severe pain are also excluded from the study. Sixty patients will randomly assign to intervention and control group (30 patients in each group) after the surgery. Intervention group will receive reflexology massage and the control group will receive none. intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052824487N2
Registration date:2016-07-30, 1395/05/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-30, 1395/05/09
Registrant information
Name
Hamid Robat Sarpooshi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4421 7146
Email address
robatsarpushih1@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research, Sabzevar University of Medical Sciences
Expected recruitment start date
2016-04-11, 1395/01/23
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of reflective massage on nasue and vomiting after laparoscopic cholecystectomy"
Public title
The effect of reflexology on nausea and vomiting after cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing laparoscopic cholecystectomy, between 20-60 years old; no history of previous gastrointestinal disorders such as gastritis, gastroesophageal reflux or clear before the operation. Exclusion criteria: laparoscopy to laparotomy lead, during a drag operation for more than 2 hours; drugs out of the anesthesia protocol specified; patients with postoperative need for embedded NGT find out, opting to participate in the study, body mass index (BMI ) More than 30, having a history of reflexology. 8. No smoking addiction and severe pain which 9.sever pajn by Visual Analogue Scale (NRS) is measured
Age
From 20 years old to 60 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Sciences of sabzevar university
Street address
Sabzevar next to a police building
City
Sabzevar
Postal code
9613873136
Approval date
2016-04-11, 1395/01/23
Ethics committee reference number
IR.MEDSAB.REC.1394.176
2
Ethics committee
Name of ethics committee
Medical Sciences of sabzevar university
Street address
Sabzevar next to the police building (1)
City
sabzevar
Postal code
9415984788
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.MEDSAB.REC.1394.176
Health conditions studied
1
Description of health condition studied
cholesistectomy
ICD-10 code
K80.4
ICD-10 code description
Calculus of bile duct with cholecystitis
Primary outcomes
1
Description
vomiting
Timepoint
in recovery and 6 and 12 hourse after operation
Method of measurement
A visual analoge scale to assess the severity of vomiting
2
Description
nausea
Timepoint
in recovery and 6 and 12 hourse after operation
Method of measurement
A visual analoge scale to assess the severity of nausea
3
Description
pain
Timepoint
in recovery and 6 and 12 hourse after operation
Method of measurement
Pain is measured by numerical rating scale
Secondary outcomes
1
Description
pain
Timepoint
in recovery and 6,12 hourses after operation
Method of measurement
pain Measured by the numerical rating scale
Intervention groups
1
Description
Foot Reflexology Massage is performed for the intervention group and the control group no intervention takes placeOn the left foot and right foot reflexology massage for 10 minutes each Khvrshydkh network in the area at the bottom of both feet, just below the toe junction of the second and third metatarsal done by researchers
Category
Other
2
Description
The control group received intervention will not be
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
imam ali hospital of bojnord
Full name of responsible person
miss mansori
Street address
bojnord
City
bojnord
2
Recruitment center
Name of recruitment center
imam ali hospital of bojnord
Full name of responsible person
miss mansori
Street address
bojnord chamran street daneshgah street
City
bojnord
3
Recruitment center
Name of recruitment center
samen hospital of bojnord
Full name of responsible person
miss sameni moghadam
Street address
bojnord chamran street
City
bojnord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar Univercity Of Medical Sience
Full name of responsible person
mr mus-aireza tadayon far
Street address
Building the Education Department of Sabzevar University of Medical Sciences
City
sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar Univercity Of Medical Sience
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
Sabzevar Univercity Of Medical Sience
Full name of responsible person
mrs marziye badakhsh
Position
Master Student in Nursing
Other areas of specialty/work
Street address
bojnord, keshavarz street, no. 11
City
bojnord
Postal code
9613873136
Phone
+98 58 3229 5876
Fax
Email
marzibadakhsh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Siences Of Sabzevar University
Full name of responsible person
mr mehdi jafar zade
Position
master of nursing
Other areas of specialty/work
Street address
sabzevar near the police
City
sabzevar
Postal code
9613873136
Phone
+51 44 264462
Fax
Email
mjafarzade4@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Sciences Of Sabzevar University
Full name of responsible person
mrs marziye badakhsh
Position
master nursing student
Other areas of specialty/work
Street address
north khorasan bojnord keshavarz street no.11
City
bojnord
Postal code
9415984788
Phone
+58 32295876
Fax
Email
marzibadakhsh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)