Comparison of the effect of massage therapy and Transcutaneous Electric Nerve Stimulation (TENS) on shoulder pain in patients after laparoscopic cholecystectomy
Determining and comparing the effect of massage therapy and Transcutaneous electrical nerve stimulation (TENS) on shoulder pain in patients after laparoscopic cholecystectomy
Design
Clinical trial on 180 patients who were candidates for laparoscopic cholecystectomy with a control group, based on the target population, double-blind and randomized by block method with a volume of 6
Settings and conduct
This study is performed on patients who are candidates for laparoscopic cholecystectomy in Imam Reza (AS) Hospital in Kermanshah. Massage and TENS techniques are performed after cholecystectomy (4, 8 and 12 hours after Surgery) in three steps. pain intensity 20 minutes after each intervention period are assessed using the Visual Analogue Scale (VAS)
Participants/Inclusion and exclusion criteria
Inclusion criteria: VAS shoulder pain intensity score at baseline (within 3 hours after surgery)
According to the American Society of Anesthesiology (ASA) classification, the patient is in grade 1 or 2
Satisfaction to participate in research orally and in writing
Exclusion criteria:
Having wounds, phlebitis, trauma arthritis in the massage area
Having a cognitive psychomotor disorder
Opioid addiction
Intervention groups
Examples include three groups: massage therapy, Transcutaneous electrical nerve stimulation (TENS), and control. The control group will include patients who have not had an intervention and will receive routine care. The massage therapy group massages the hand area for 30 minutes. In the TENS method, the electrodes are placed near or on the pain site and send the stimuli created by the device to the skin to stimulate the sensory-nerve terminals.
Main outcome variables
Patients's shoulder pain score based on the VAS scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200206046395N1
Registration date:2022-02-05, 1400/11/16
Registration timing:prospective
Last update:2022-02-05, 1400/11/16
Update count:1
Registration date
2022-02-05, 1400/11/16
Registrant information
Name
Mobin Mottahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3233 8090
Email address
mobinmottahedi1372@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of massage therapy and Transcutaneous Electric Nerve Stimulation (TENS) on shoulder pain in patients after laparoscopic cholecystectomy
Public title
Comparison of the effect of massage therapy and Transcutaneous Electric Nerve Stimulation (TENS) on shoulder pain in patients after laparoscopic cholecystectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A VAS Shoulder pain intensity score at baseline (within 3 hours after consciousness) of greater than or equal to 30 mm on a 100 mm VAS scale with 0 = no pain and 100 = worst pain imaginable.
According to the American Society of Anesthesiology (ASA) classification, the patient is in grade l or ll
consent to participate in oral and written research
Not to have internal cardiac pacemaker
Not pregnancy
Exclusion criteria:
having wounds, phlebitis, trauma arthritis in the massage area
Having a cognitive psychomotor disorder
Addiction to painkillers and opiates
Cardiovascular disease
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Pre-sampling of the type will be available. Then, the samples studied in this study will be placed in the study groups (control, TENS intervention and massage intervention) using random allocation of patients.
The random allocation sequence is determined using the block method with a volume of 6 using the software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is double-blind because participants receiving the intervention are aware of the intervention. The data collector will not be aware of the patient group. The data analyzer will not be aware of the patient group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Building No. 2 of Kermanshah University of Medical Sciences,Shahid beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2022-01-11, 1400/10/21
Ethics committee reference number
IR.KUMS.REC.1400.757
Health conditions studied
1
Description of health condition studied
Laparoscopic cholecystectomy
ICD-10 code
K91.86
ICD-10 code description
Retained cholelithiasis following cholecystectomy
Primary outcomes
1
Description
Shoulder pain score in Visual Pain Scale Questionnaire
Timepoint
baseline (within 3 hours after consciousness).4, 8 and 12 hours after surgery
Method of measurement
VAS Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Massage - Massage therapy group 30 minutes with three massage methods Petrisag-Kneading-Friction in the hand area. This technique is performed three times after cholecystectomy (4, 8 and 12 hours after consciousness). Patients' pain intensity is measured and recorded 20 minutes after each massage with the Visual Pain Scale (VAS).
Category
Treatment - Devices
2
Description
Intervention group: TENS In the TENS method, electrodes are placed near or on the shoulder pain site and send the stimuli created by the device to the skin to stimulate the sensory-nerve terminals. Also, in order to achieve effective and rapid pain relief, the TENS current (frequency of 150 Hz and a pulse width of 75 μs) Used for 30 minutes. This technique is performed three times after cholecystectomy (4, 8 and 12 hours after surgery). Patients' pain intensity is measured and recorded 20 minutes after each TENS with a Visual Analogue Scale (VAS).
Category
Treatment - Devices
3
Description
Control group: Get routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital in Kermanshah
Full name of responsible person
MOBIN MOTTAHEDI
Street address
Kermanshah-Nurse Boulevard
City
kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3427 6300
Email
info@irhk.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
MOBIN MOTTAHEDI
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Operating room
Street address
Square of kargar_navvab
City
shahrood
Province
Semnan
Postal code
3618675313
Phone
009832338090
Email
Mobinmottahedi1372@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
MOBIN MOTTAHEDI
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
operating room
Street address
Square kargar-navvab
City
shahrood
Province
Semnan
Postal code
3618675313
Phone
009832338090
Email
mobinmottahedi1372@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
MOBIN MOTTAHEDI
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
operating room
Street address
Square kargar-navvab
City
shahrood
Province
Semnan
Postal code
3618675313
Phone
009832338090
Email
mobinmottahedi1372@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Individual participant data collected for the primary outcome measures
When the data will become available and for how long
After publication for one year
To whom data/document is available
For all people who request for data
Under which criteria data/document could be used
It is allowed to perform any analysis on the data, but use of data for publication is not allowed.
From where data/document is obtainable
Corresponding author of article
What processes are involved for a request to access data/document
After requesting the data by email to corresponding author , the data will be sent after a maximum period of one week