Effects of acupuncture on ear pain, blood parameters, hemodynamic indices, stress, nausea and vomiting in surgical candidates
Design
This study was a double-blind clinical trial with parallel groups that were randomly divided into control and intervention groups.
Settings and conduct
Patients will be randomly divided into intervention and control groups by random number table. Patients in the intervention group will receive massage for 15 minutes at thalamic point of right ear. It should be noted that the researcher and the data analyst are uninformed and blind in the study. No action will be taken for the control group. All operations will be performed in the hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: consent to participate in the study
Exclusion criteria: no ear problems, no ear infections
Intervention groups
Intervention group will receive thalamus point massage in right ear for 15 minutes. The control group will not take any action.
Main outcome variables
Pain
Stress
Nausea and vomiting
The amount of opioid needed
Hemodynamic indices
Blood indicators indicate pain and stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N10
Registration date:2019-09-14, 1398/06/23
Registration timing:registered_while_recruiting
Last update:2019-09-14, 1398/06/23
Update count:0
Registration date
2019-09-14, 1398/06/23
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of acupuncture on ear pain, blood parameters, hemodynamic indices, stress, nausea and vomiting in surgical candidates
Public title
The effects of ear acupressure in surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Exclusion criteria:
Problems in the ear
Infection in the ear
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher and the data analyzer are blind to the type of grouping and division into different groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.TBZMED.REC.1397.1059
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Pain
Timepoint
4 times a day, every six hours and six hours after surgery
Method of measurement
Visual Analogue Scale
2
Description
Stress
Timepoint
Once a day before surgery
Method of measurement
Stress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive right thalamus point massage for 15 minutes by a specialist masseur who is highly skilled in performing massages. The variables of hemodynamic status, blood parameters, pain, stress and nausea and vomiting will be measured before and after the intervention. The researcher and the person analyzing the data are blind during the study.
Category
Prevention
2
Description
Control group: This group will not receive any intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Mehdi Khanbabayi Gol
Street address
Azadi Ave, Shahid Madani Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3535 3696
Email
mkhanbabayi@yahoo.com
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mehdi Khanbabayi Gol
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 21 3335 5921
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available