Protocol summary
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Study aim
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Determining and comparing the effect of massage therapy and Transcutaneous electrical nerve stimulation (TENS) on shoulder pain in patients after laparoscopic cholecystectomy
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Design
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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
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Settings and conduct
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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 before and after each intervention period are assessed using the Visual Analogue Scale (VAS)
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Participants/Inclusion and exclusion criteria
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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
Having shoulder pain before surgery
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Intervention groups
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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.
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Main outcome variables
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Patients's shoulder pain score based on the VAS scale
General information
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Reason for update
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By updating the study, we try to complete the research process, and for this reason, we made the necessary corrections to achieve more explicit results.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200206046395N1
Registration date:
2022-02-05, 1400/11/16
Registration timing:
prospective
Last update:
2022-03-19, 1400/12/28
Update count:
1
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Registration date
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2022-02-05, 1400/11/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-02-20, 1400/12/01
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Expected recruitment end date
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2022-04-21, 1401/02/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effect of massage therapy and Transcutaneous Electric Nerve Stimulation (TENS) on shoulder pain in patients after laparoscopic cholecystectomy
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Public title
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Comparison of the effect of massage therapy and Transcutaneous Electric Nerve Stimulation (TENS) on shoulder pain in patients after laparoscopic cholecystectomy
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
A VAS Shoulder pain intensity score at baseline (within 3 hours after surgery) 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
Having shoulder pain before surgery
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
180
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-01-11, 1400/10/21
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Ethics committee reference number
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IR.KUMS.REC.1400.757
Health conditions studied
1
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Description of health condition studied
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Laparoscopic cholecystectomy
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ICD-10 code
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K91.86
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ICD-10 code description
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Retained cholelithiasis following cholecystectomy
Primary outcomes
1
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Description
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Shoulder pain score in Visual Pain Scale Questionnaire
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Timepoint
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Before intervention,baseline (within 3 hours after surgery).4, 8 and 12 hours after surgery
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Method of measurement
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VAS Visual Analog Scale
Secondary outcomes
1
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Description
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Taking analgesic drugs
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Timepoint
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end of surgery
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Method of measurement
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check list
2
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Description
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Time of the first dose of analgesic
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Timepoint
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end of surgery
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Method of measurement
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check list
Intervention groups
1
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Description
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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 surgery). Patients' pain intensity is measured and recorded 20 minutes before and after each massage with the Visual Pain Scale (VAS).
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Category
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Treatment - Devices
2
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Description
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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. the intensity of each channel was increased until the participant was able to feel a maximal tolerable tingling sensation without causing discomfort, pain, or muscle contraction.This technique is performed three times after cholecystectomy (4, 8 and 12 hours after surgery). Patients' pain intensity is measured and recorded 20 minutes before and after each TENS with a Visual Analogue Scale (VAS).
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Category
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Treatment - Devices
3
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Description
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Control group: Get routine care
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kermanshah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Individual participant data collected for the primary outcome measures
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When the data will become available and for how long
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After publication for one year
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To whom data/document is available
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For all people who request for data
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Under which criteria data/document could be used
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It is allowed to perform any analysis on the data, but use of data for publication is not allowed.
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From where data/document is obtainable
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Corresponding author of article
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What processes are involved for a request to access data/document
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After requesting the data by email to corresponding author , the data will be sent after a maximum period of one week
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Comments
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