Determining the Comparison the Effect of Acupressure and Auriculotherapy on Shoulder Pain in Patients subjected to Laparoscopic Cholecystectomy
Design
Clinical trial with control group, single blind on 93 patients. The permutation Blocking Method will be used for Randomization.
Settings and conduct
Patients undergoing Cholecystectomy in Birjand hospitals are divided into three groups: Acupressure, Auriculotherapy and Control.
After surgery, the amount of pain is measured with the VAS (Visual Analogue Scale) scale, then the intervention is performed.
Patients will complete the VAS scale again 1 hour, 4 hours and 8 hours after the intervention.
The researcher assistance who is unaware of the groupings and type of interventions in each group is used for blinding.
Participants/Inclusion and exclusion criteria
Entry conditions: patients stay in the hospital for at least one day after surgery; be able to provide informed written consent; no lesions or wounds in the areas where acupressure is to be applied; no history of chronic pain in the shoulder or neck; no need for simultaneous combination surgery.
Exit conditions: existence of any disease related to bleeding or abnormal blood clotting; pregnancy or breastfeeding; history of seizures, dementia.
Intervention groups
After surgery, the amount of pain is measured with the VAS (Visual Analogue Scale) scale, then the intervention is performed.
Acupressure is performed on the GB21, ST38, TW15 points by the researcher's thumb pulp.
Auriculotherapy is performed on the shoulder, shoulder joint, and clavicle with ear probe.
The control group will not receive any intervention.
All three groups will receive routine care.
Patients will complete the VAS scale again 1 hour, 4 hours and 8 hours after the intervention.
Main outcome variables
Shoulder Pain in Patients subjected to Laparoscopic Cholecystectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220310054249N1
Registration date:2022-03-25, 1401/01/05
Registration timing:prospective
Last update:2022-03-25, 1401/01/05
Update count:0
Registration date
2022-03-25, 1401/01/05
Registrant information
Name
Mona Zohourparvaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3621 8648
Email address
monazparvaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the Effect of Acupressure and Auriculotherapy on Shoulder Pain in Patients subjected to Laparoscopic Cholecystectomy
Public title
Acupressure in Cholecystectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients stay in the hospital for at least one day after surgery
Be able to provide informed written consent
No lesions or wounds in the areas where acupressure is to be applied
Have no history of chronic pain in the shoulder or neck
No need for simultaneous combination surgery
Exclusion criteria:
Existence of any disease related to bleeding or abnormal blood clotting
Pregnancy or breastfeeding
History of seizures
Dementia
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
93
Randomization (investigator's opinion)
Randomized
Randomization description
All sample subjects are divided into three equal groups by simple random methods. First, 93 cards (equal to the number of sample volumes) will be prepared. Then A, B or C will be written on each card (31 cards A, 31 cards B and 31 cards C). These cards will be placed inside a box so that no one can see the cards inside the box. After shuffling the cards by the researcher, patients are asked to randomly take a card from the box (selected cards will not be returned to the box after selection). Thus, people are divided into three groups of 31 people A, B and C. In this way, three cards are prepared and one of the numbers one (acupressure), 2 (auriculotherapy) and 3 (control) will be written on each card. These cards are placed in a box and after shuffling, the researcher will randomly select a card for each group (the selected cards will not be returned to the box after selection).
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher assistance will be used to complete all questionnaires to blind and prevent bias in the results. This person will be unaware of the groupings and the type of interventions that are performed in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari St., Birjand University of Medical Sciences, Vice Chancellor for Research and Technology
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2022-03-09, 1400/12/18
Ethics committee reference number
IR.BUMS.REC.1400.444
Health conditions studied
1
Description of health condition studied
Cholecystitis
ICD-10 code
K81
ICD-10 code description
Cholecystitis
Primary outcomes
1
Description
Shoulder Pain after Laparoscopic Cholecystectomy
Timepoint
Pain is measured after surgery and immediately after entering the ward, 1 hour, 4 hours and 8 hours after the intervention.
Method of measurement
VAS Scale (Visual Analog Scale)
Secondary outcomes
1
Description
Comfort
Timepoint
Comfort is measured after surgery and immediately after entering the ward, 1 hour, 4 hours and 8 hours after the intervention.
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Acupressure is performed on GB21 points in the most prominent part of shoulder muscle, ST38 in lateral tibial cortex and between the distance between external ankle and popliteal crease, TW15 in the middle of the hypothetical line between the lower end of the seventh cervical vertebra and the acromion head by the researcher's thumb pulp. The amount of pressure is 3 to 4 kg, which is calibrated by the pressure of the therapist's hand on a digital scale. Pressure time for each point is 3 minutes of pressure and 1 minute of rest to our patient between two points on one side of the body (the same side that hurts).
Category
Rehabilitation
2
Description
Intervention group: Auriculotherapy is performed on the shoulder, shoulder joint, and clavicle points by a special ear prop. The amount of prop pressure in the ear is 1 to 2 kg, which is calibrated on a digital scale. Pressure time for each point is 3 minutes of pressure and 1 minute of rest to the patient between two points in one ear (ear is the same part of the body that is in pain).
Category
Rehabilitation
3
Description
Control group: The control group will not receive any intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery Department of Birjand Hospitals
Full name of responsible person
Dr. Mohammad Reza Ghasemian Moghaddam
Street address
Ayatollah Taleghani St., Imam Reza Hospital
City
Birjand
Province
South Khorasan
Postal code
9714811151
Phone
+98 56 3222 2300
Email
emamreza@bums.ac.ir
Web page address
https://www.bums.ac.ir/page-emamrezares
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Reza Miri
Street address
University of Medical Sciences - Education and Research Building - Second Floor - Vice Chancellor for Research and Technology
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
Miri_moh2516@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mona Sadat Zohourparvaz
Position
Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1407
Email
monazparvaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyyed Abolfazl Vagharseyyedin
Position
Associate Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1407
Email
Waghars@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mona Sadat Zohourparvaz
Position
Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1407
Email
monazparvaz@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