The comparative effect of pressure acupressure and low-level laser acupressure on P6 point to the control of postoperative nausea and vomiting after abdominal laparoscopic surgery.
1. To investigate the effect of pressure acupressure on the P6 point in reducing postoperative nausea and vomiting.
2. To investigate the effect of low-power laser acupressure on the P6 point in reducing postoperative nausea and vomiting.
Design
This study is a double-blind clinical trial with parallel and randomized groups. Based on the block permutation method, 118 patients are enrolled in the study.
Settings and conduct
20 minutes before induction of general anesthesia, all patients will receive pressure cuffs at the p6 points on both hands.
Patients in group A will receive 15 minutes of laser acupressure using a diode laser with a wavelength of 808 nm and a power of 20 mw at the p6 point on both hands, and the pressure cuffs will not exert any effective pressure.
Patients in group B will receive 15 minutes of pressure acupressure with a pressure cuff at the P6 point of both hands with enough pressure not to affect venous return.
In order to blind the patients in group B, the described diode laser without active radiation is placed at the P6 point.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18 to 75 years old, no history of motion sickness/use of antiemetics
Exclusion criteria: lack of consent to continue in the study
Intervention groups
There are two groups in this study.
The intervention in group A is to investigate the effectiveness of laser acupressure on P6 point on postoperative nausea and vomiting.
The intervention in group B is to investigate the effectiveness of pressure acupressure on P6 point on postoperative nausea and vomiting.
Main outcome variables
The severity of postoperative nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250101064239N1
Registration date:2025-01-28, 1403/11/09
Registration timing:prospective
Last update:2025-01-28, 1403/11/09
Update count:0
Registration date
2025-01-28, 1403/11/09
Registrant information
Name
Reza Namdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 4986
Email address
reza.namdari78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-21, 1404/01/01
Expected recruitment end date
2025-09-22, 1404/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative effect of pressure acupressure and low-level laser acupressure on P6 point to the control of postoperative nausea and vomiting after abdominal laparoscopic surgery.
Public title
The comparative effect of pressure acupressure and low-level laser acupressure on P6 point to the control of postoperative nausea and vomiting after abdominal laparoscopic surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between the ages of 18 and 75 years old
Patients who are candidates for elective laparoscopic abdominal surgery
Patients with American society of anesthesiologists (ASA) class 1 and 2
Patients with no history of motion sickness or chemotherapy
Patients with informed consent
Patients who have not taken antiemetics in the past 48 hours
Patient alertness and cooperation in completing the Nausea and Vomiting Severity Questionnaire
Exclusion criteria:
Unwillingness to continue study participation
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
This is done using the block permutation method.
Based on this method, the organizer of the operating room, who is not the same person for data collection, before sending patients to the operating room, will categorize patients into two groups of A and B in the recursive following order "AABB, ABAB, ABBA, BBAA, BABA".
For example: (AABB), the first and second patients in group A, the third and fourth patients in group B; (ABAB), the fifth and seventh patients in group A, the sixth and eighth patients in group B, and so on.
The person responsible for data collection in the recovery room is not informed of the patient categories.
Blinding (investigator's opinion)
Double blinded
Blinding description
The operating room organizer will divide the patients into A and B groups just before entering the operating room.
Pressure acupressure and laser acupressure are performed by the anesthesiologist in the operating room.
Since the patients and the person responsible for data collection and analysis are unaware of the group categorization, this study is a double-blind clinical trial.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Measuring the severity of nausea and vomiting in hours 0-2-4-12-24 after surgery.
Method of measurement
Vomiting score
Secondary outcomes
1
Description
The amount of ondansetron required
Timepoint
0, 2, 4, 12, 24 hours after surgery
Method of measurement
Amount of intravenous ondansetron needed (milligram)
Intervention groups
1
Description
Intervention group: 20 minutes before induction of general anesthesia, laser acupressure is applied to the P6 point of both hands for 15 minutes using a diode laser with a wavelength of 808 nm and a power of 20 mw. In order to blind the patients, pressure cuffs without effective pressure are also applied to the same P6 point on both hands.
Category
Prevention
2
Description
Intervention group: 20 minutes before induction of general anesthesia, pressure acupressure is applied to the P6 point of both hands for 15 minutes using pressure cuffs at a pressure level that does not affect venous return. To blind the patients, a diode laser with a wavelength of 808 nm and a power of 20 mw without effective radiation is also applied to the same P6 point on both hands.