Comparison of the effects of compression bracelet and compression sticker at p6 on patients’ physiological indices and postoperative nausea and vomiting prevention in laparascopic cholecystectomy
Comparison of the effects of compression bracelet and compression sticker at p6 on patients’ physiological indices and postoperative nausea and vomiting prevention in laparascopic cholecystectomy
Design
Clinical trial with control group, Randomized, with parallel groups, single blind
Settings and conduct
The aim of this study was to determine the prevalence of postoperative nausea and vomiting in the medical centers of Hamadan using a bracelet and a tag in patients in the study groups. It should be noted that by removing the metal button on the bracelet as well as the pressure tag, the blinding is done in the sampling phase.
Participants/Inclusion and exclusion criteria
Patient Entry Conditions:
Patients Candidate for Laparoscopic Cholecystectomy with General Anesthesia
Age over 18 years
P6 skin health
No nausea for any reason before entering the study
No visual impairment to diagnose VAS
No angiocut at point P6
And exclusion criteria include:
The patient is discharged before the end of the study
Patient dissatisfaction to continue the study
Sensitivity to acupuncture bracelet and label
Bleeding and any factors that lead to open surgery
Intervention groups
The grop of P6 acupressure bracelet
The grop of P6 acupressure sticker
Control group without any intervention
Main outcome variables
Prevention of nausea and vomiting؛Hemodynamic stability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190915044770N1
Registration date:2019-10-25, 1398/08/03
Registration timing:registered_while_recruiting
Last update:2019-10-25, 1398/08/03
Update count:0
Registration date
2019-10-25, 1398/08/03
Registrant information
Name
Asghar Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3822 4894
Email address
asghar.farahani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of compression bracelet and compression sticker at p6 on patients’ physiological indices and postoperative nausea and vomiting prevention in laparascopic cholecystectomy
Public title
The effect of pressure bracelet and pressure sticker on nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for Laparoscopic Cholecystectomy with General Anesthesia
Age over 18 years
Having skin health at P6
No nausea for any reason before entering the study
No visual impairment to diagnose VAS
No angiocut at point P6
Exclusion criteria:
The patient is discharged before the end of the study
Patient dissatisfaction to continue the study
Sensitivity to acupuncture bracelet and acupressure sticker
Bleeding and any factors that lead to open surgery
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
175
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients in this study were blinded to pressure bracelet and pressure tag groups in the intervention and control groups. They are not aware of the type of bracelet (with or without a push button) and a push sticker (with or without a metal piece) that both instruments have a complete similarity to each other.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan university of medical sciences
Street address
Shahid Fahmideh BLVD
City
Hamadan
Province
Hamadan
Postal code
6517838698
Approval date
2019-08-10, 1398/05/19
Ethics committee reference number
IR.UMSHA.REC.1398.428
Health conditions studied
1
Description of health condition studied
Cholecystectomy
ICD-10 code
K91.86
ICD-10 code description
Retained Cholelithiasis following Cholecystectomy
Primary outcomes
1
Description
Prevention of nausea
Timepoint
Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
2
Description
Beating
Timepoint
Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery
Method of measurement
Find abundance with checklists
3
Description
Vomiting
Timepoint
Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery
Method of measurement
Find abundance with checklists
4
Description
Pain
Timepoint
Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
5
Description
The amount of anti-nausea and vomiting medication
Timepoint
24 hours after surgery
Method of measurement
Check list
6
Description
Blood pressure measurement
Timepoint
Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery
Method of measurement
Handheld pressure gauge
7
Description
The number of pulses per minute
Timepoint
Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery
Method of measurement
Cardiac monitoring device
8
Description
Breath rate per minute
Timepoint
Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery
Method of measurement
Visual observation
9
Description
Body temperature
Timepoint
Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery
Method of measurement
Mercury thermometer
10
Description
Arterial Oxygen Saturation Percentage
Timepoint
Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery
Method of measurement
Cardiovascular monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group with pressure bracelet at point P6. After selecting the appropriate wristband, the researcher closed the patient's wrist one hour before starting anesthesia on the P6 point and held it for 6 hours after embedding and then removing it. It should be noted that the severity of nausea based on the VAS visual scale, the severity of pain based on the visual VAS scale, the frequency of vomiting based on the checklist, as well as vital symptoms including respiratory rate, heart rate, blood pressure and temperature They are measured at times immediately after full consciousness in recovery, one hour later, 6 hours later, and 24 hours after surgery. The checklist will also be assessed 24 hours after surgery.
Category
Prevention
2
Description
Intervention group: group with pressure sticker at point P6. After selecting the appropriate sticker, the researcher closed the patient's sticker one hour before starting anesthesia on the P6 point and held it for 6 hours after embedding and then removing it. It should be noted that the severity of nausea based on the VAS visual scale, the severity of pain based on the visual VAS scale, the frequency of vomiting based on the checklist, as well as vital symptoms including respiratory rate, heart rate, blood pressure and temperature They are measured at times immediately after full consciousness in recovery, one hour later, 6 hours later, and 24 hours after surgery. The checklist will also be assessed 24 hours after surgery.
Category
Prevention
3
Description
Control group: No specific action is taken
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Asghar Farahani
Street address
Hokama St, Motahari BLVD
City
Hamadan
Province
Hamadan
Postal code
6514845471
Phone
+98 81 3264 0022
Email
besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Asghar Farahani
Street address
Shahid Fahmideh BLVD
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3251 6632
Email
Info.Research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahnaz Khatiban
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh BLVD
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0320
Email
mahnaz.khatiban@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
asghar Farahani
Position
Master of science Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh BLVD
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3822 4864
Email
asghar.farahani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Asghar Farahani
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh BLVD
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3822 4864
Email
asghar.farahani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD