Protocol summary
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Study aim
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The effect of topical heat therapy on shoulder pain after laparoscopic gallbladder surgery
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Design
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clinical trial that randomized clinical trial method is throwing the dice.
Non-blind, with three groups (right shoulder heat therapy and heat treatment operation and control), with parallel groups with sample size of 61
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Settings and conduct
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This study was a randomized clinical trial and patients were assigned to three groups of right shoulder warmth, positional heat therapy and control based on simple randomization.
The sample size was 20 persons in each group and the study site was Allameh Behlul Hospital of Gonabad. There was no intervention for control group patients.
For right shoulder and position shoulder surgery group, the patients were treated for 20 minutes after expressing pain.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age between 18 to 60 years, laparoscopic cholecystectomy, patient's willingness to participate in the study
Exclusion criteria include: history of shoulder surgery and anatomical abnormalities, shoulder dislocation or fracture, underlying disease such as diabetes and peripheral vascular disease, drug addiction, acute cholecystitis, common bile duct stones, recent pancreatitis and jaundice , Gallbladder rupture and bile leak at the site of operation and severe intraoperative bleeding
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Intervention groups
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Intervention group 1: Silicate hot pack heated by Hot Pack at 70 ° C, wrapped around towel at 50 ° C for 20 minutes in right shoulder, Pain severity was measured after the intervention at 20 and 40 minutes by visual analogue scale.
Intervention group 2: All of the above steps were performed except the hot water bag was in the operative position.
Control group: In this group all of these procedures except the hot water bag were performed.
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Main outcome variables
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Shoulder pain severity
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180221038821N3
Registration date:
2019-12-13, 1398/09/22
Registration timing:
retrospective
Last update:
2020-03-25, 1399/01/06
Update count:
1
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Registration date
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2019-12-13, 1398/09/22
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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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2019-01-21, 1397/11/01
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Expected recruitment end date
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2019-09-23, 1398/07/01
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Actual recruitment start date
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2019-02-04, 1397/11/15
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Actual recruitment end date
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2019-09-12, 1398/06/21
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Trial completion date
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2019-09-23, 1398/07/01
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Scientific title
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Effect of Local Heat Therapy on Shoulder Pain of after Laparascopic Cholecystectomy
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Public title
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Effect of Local Heat Therapy on Shoulder Pain of after Laparascopic Cholecystectomy
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Ages 18 to 60 years
Surgery by laparoscopic cholecystectomy
Patient willingness to participate in the study
Exclusion criteria:
Shoulder surgery history and anatomical abnormalities and shoulder dislocation or fractures
Underlying disease such as diabetes and peripheral vascular disease
Drug addiction
Acute cholecystitis
Common bile duct stones
Recent pancreatitis and jaundice
Gallbladder rupture and bile leak at the site of operation
Severe intraoperative bleeding
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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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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients were selected using purposive sampling method and applying inclusion criteria.
Then by throwing dice, three right shoulder thermotherapy group (numbers 1 and 2), Therapeutic stance of action (numbers 3 and 4) and control (numbers 5 and 6) were assigned.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2018-11-22, 1397/09/01
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Ethics committee reference number
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IR.GMU.REC.1397.091
Health conditions studied
1
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Description of health condition studied
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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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Severity of shoulder pain after laparoscopic cholecystectomy
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Timepoint
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Before intervention, 20 and 40 minutes after intervention
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Method of measurement
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Pain severity was measured using the Visual Analogue Scale.
Intervention groups
1
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Description
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Intervention group1: In this group, thermotherapy for research units were placed in the right shoulder by using a hot water bag heated to 70 ° C, wrapped around a towel and 50 ° C, for 20 minutes.
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Category
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Other
2
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Description
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Intervention group2: In this group, thermotherapy for research units were Position surgery by using a hot water bag heated to 70 ° C, wrapped around a towel and 50 ° C, for 20 minutes.
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Category
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Other
3
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Description
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Control group: For the research units in this group only routine care was performed.
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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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Gonabad 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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After receiving the results of the decision for the publication, I will produce results.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available