Protocol summary

Summary
A randomized controlled clinical trial study will be conducted with the aim of evaluation of the effect of acupressure of P6 and Le7 acu-points on nausea and vomiting, pain and vital signs of post-appendectomy patients. Post appendectomy patients are the participants in the study. A convenience sample of post appendectomy patients will be randomly allocated within the 3 groups. (45 patients in each group). Having an appendectomy surgery and willing to participate in the research are the main criteria for inclusion and occurring a complications during surgery or prolongation of the surgery (more than 2 hours) are the main criteria for excluding the patients from the study. The first group will receive acupressure on p6 acu-point. The second group will receive acupressure on le7 acu-point. The third group includes control group who will receive light pressure on shame points. Acupressure will be applied using an acuband in which a button applies pressure on the concerned acu-point. The intervention begins in the recovery room after full consciousness op the patients. At first, the severity of pain, existing and severity of nausea and vomiting, and the vital signs of the patients will be assessed and recorded in the checklist. Then the acuband will be placed on the concerned acu-point. The acuband will be maintained on the acu-points for seven hours. The severity of pain, existing and the severity of nausea and vomiting, and vital signs of the each patient will be assessed every hours. The severity of pain, severity of nausea and vomiting, and the quality of vital signs are the main outcome measures of the study. Data will be analyzed using t test, ANOVA, chi-square test, Fisher's exact test and kruskal wallis. For all tests, the maximum error of 0.05 will be considered.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112118374N1
Registration date: 2012-03-24, 1391/01/05
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-03-24, 1391/01/05
Registrant information
Name
Mahmood Etri
Name of organization / entity
Khashan university of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 31 1780 2017
Email address
etri-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2012-05-20, 1391/02/31
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupressure of P6 and Le7 accupoints on nausea,vomiting, pain and vital sign patients with appendectomy surgery that referred to Alzahra hospital in Isfahan -1391
Public title
Effect of acupressure on nausea,vomiting, pain and vital sign patients with appendectomy surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willing to participate in the research; having no problem in the concerned limbs that interfere acupressure on p6 or le7 points; age between 20 to 60 years; appendectomy surgery is done; general anesthesia have been applied for the surgery. Exclusion criteria: Unpredicted complications during surgery; prolongation of the surgery (more than 2 hours); experiencing nausea and vomiting during the previous surgeries; using drugs other than those usual drugs; having a recent history of nausea and vomiting associated with acute or chronic diseases (digestive disorders, ear, and ...); addicted to the drugs or/and alcohol; having cancer, diabetes or known gastrointestinal, renal, hepatic, respiratory, cardiovascular diseases; having problems or infections in the acupressure points; having fever
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committee of Kashan university of Medical sciences
Street address
5 km polar Ravandi Blvd
City
Kashan
Postal code
87159/88141
Approval date
2011-12-19, 1390/09/28
Ethics committee reference number
29/5/1/2923

Health conditions studied

1

Description of health condition studied
Appendicitis
ICD-10 code
K35.8
ICD-10 code description
Acute Appendicitis

Primary outcomes

1

Description
Nausea
Timepoint
Before closing the bracelet, every one hours for 7 times
Method of measurement
nausea will be measured by visual analog scale

2

Description
Vomiting
Timepoint
Before closing the bracelet, every one hours for 7 times
Method of measurement
The number of vomiting

3

Description
Pain
Timepoint
Before closing the bracelet, every one hours for 7 times
Method of measurement
Visual analog scale

4

Description
vital sign
Timepoint
Before closing the bracelet, every one hours for 7 times
Method of measurement
Blood pressure will measured by Sphygmomanometer, pulse and breathing by counting in a minute by a hand watch.

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group will receive acupressure on p6 acu-point.
Category
Treatment - Drugs

2

Description
The second intervention group will receive acupressure on le7 acu-point.
Category
Treatment - Drugs

3

Description
The control group will receive pressure on Sham point.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Mahmood Etri
Street address
Sofeh Shohada street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
5th km of the Ravand road
City
Kashan
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, Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mahmood Etri
Position
Graduate student of nursing
Other areas of specialty/work
Street address
5th km of Ravand road
City
Kashan
Postal code
8715981191
Phone
+98 36 1555 2999
Fax
+98 36 1555 6633
Email
etri_m@kaums.ac.ir; etrimahmood@yahoo.com; adib1344@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan university of medical sciences
Full name of responsible person
Mohsen Adib-Hajbaghery
Position
Ph.D
Other areas of specialty/work
Street address
5th km Ravand road
City
Kashan
Postal code
8715981191
Phone
+98 36 1555 0021
Fax
+98 36 1555 6633
Email
adib1344@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan university of Medical sciences
Full name of responsible person
Mahmood Etri
Position
Msc student of nursing
Other areas of specialty/work
Street address
5th km of Ravandi road
City
Kashan
Postal code
8715981191
Phone
+98 983117802017
Fax
+98 55 56633
Email
etri_m@kaums.ac.ir; etrimahmood@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
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