Objective: To compare the effect of acupressure on PC6 and REN 12 points on patients’ nausea and vomiting after inguinal hernia repair surgery. The inclusion criteria of this randomized double-blind study are as follows: male patients of 18-60 years and inguinal hernia. The exclusion criteria are as follows: unwillingness to continue participation in the study and incidence of acute medical conditions.
Method: The researcher performs acupressure on PC6 and REN 12 points for five minutes 0, 2, 4, and 6 hours after full consciousness (time, place, and person orientation) following the inguinal hernia repair surgery. A collaborator unaware of the points under acupressure examines (Researcher assistant)
the incidence, frequency, and severity of nausea and vomiting in patients before each time of acupressure and records them in relevant tables. Patients will be unaware of the type of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111530915N1
Registration date:2017-04-12, 1396/01/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-12, 1396/01/23
Registrant information
Name
Seyyed Roohollah Najjari
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5227 0779
Email address
najjari.r@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of acupressure on PC6 and REN 12 points on patients’ nausea and vomiting after inguinal hernia repair surgery.
Public title
The comparison of the effect of acupressure on PC6 and REN 12 points on patients’ nausea and vomiting after inguinal hernia repair surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- Informed consent for participation in the study, 2- aged 18-60 years, 3- definite diagnosis of inguinal hernia based on patients’ medical records, 4- patients with Class 1 or 2 physical status of American Society of Anesthesiologist (ASA) (patients without physical diseases, no biochemical, physiological, or psychological impairment, or mild to moderate systemic disorders not related with the cause of the surgery), 5- male patients given the prevalence of this surgery in males, 6- no anatomical problems at PC6 and REN 12 points, 7- no history of using acupressure or acupuncture, 8- using general anesthesia, 9- no anti-nausea medications, H2 antagonists, and sedatives, 10- no history of conditions accompanied with acute and chronic nausea and vomiting (digestive and ear disorders, etc.), and 11- no substance or drug abuse.
Exclusion criteria: 1- unwillingness to continue participation in the study for any reason and 2- incidence of acute medical conditions during the study.
Age
From 18 years old to 60 years old
Gender
Male
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
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization. Blinding: The observer how will examine the patients will not be aware of the intervention. Patients will be unaware of the type of intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
IR.GMU.REC.1395.70
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Vomiting following gastrointestinal surgery
Primary outcomes
1
Description
Nausea
Timepoint
Before the intervention, 2, 4, and 6 hours after the intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Vomiting
Timepoint
Before the intervention, 2, 4, and 6 hours after the intervention
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Performing acupressure on PC6 point for five minutes 0, 2, 4, and 6 hours after full consciousness
Category
Treatment - Other
2
Description
Performing acupressure on REN 12 point for five minutes 0, 2, 4, and 6 hours after full consciousness