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Effect of Local Heat Therapy on Shoulder Pain of after Laparascopic Cholecystectomy

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History
# Registration date Revision Id
2 2020-02-27, 1398/12/08 126722
1 2019-12-13, 1398/09/22 113763
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  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Iman Ghorbani Moghaddam
    Full name of responsible person - Persian: ایمان قربانی مقدم
    Position - English: Bachelor of Nursing
    Position - Persian: کارشناسی پرستاری
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Student Research Committee, Gonabad University of Medical Sciences, Asian Road Margin
    Street address - Persian: حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد، کمیته تحقیقات دانشجویی
    City - English: Gonabad
    City - Persian: گناباد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9691647161
    Phone: +98 51 5722 0576
    Mobile: +98 930 239 2707
    Fax:
    Email: ghorbani.i@gmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fatemeh Ansari
    Full name of responsible person - Persian: فاطمه انصاری
    Position - English: MSc of Nursing
    Position - Persian: کارشناسی ارشد پرستاری
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Student Research Committee, Gonabad University of Medical Sciences, Asian Road Margin
    Street address - Persian: حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد، کمیته تحقیقات دانشجویی
    City - English: Gonabad
    City - Persian: گناباد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9691647161
    Phone: +98 51 5722 0576
    Mobile: +98 915 324 2998
    Fax:
    Email: ‪Ansari.fatemeh5961@gmail.com‬‏
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Iman Ghorbani Moghaddam
    Full name of responsible person - Persian: ایمان قربانی مقدم
    Position - English: Student Bachelor of Nursing
    Position - Persian: دانشجو کارشناسی پرستاری
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Student Research Committee, Gonabad University of Medical Sciences, Asian Road Margin
    Street address - Persian: حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد، کمیته تحقیقات دانشجویی
    City - English: Gonabad
    City - Persian: گناباد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9691647161
    Phone: +98 51 5722 0576
    Mobile: +98 930 239 2707
    Fax:
    Email: ghorbani.i@gmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fatemeh Ansari
    Full name of responsible person - Persian: فاطمه انصاری
    Position - English: MSc of Nursing
    Position - Persian: کارشناس ارشد پرستاری
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Student Research Committee, Gonabad University of Medical Sciences, Asian Road Margin
    Street address - Persian: حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد، کمیته تحقیقات دانشجویی
    City - English: Gonabad
    City - Persian: گناباد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9691647161
    Phone: +98 51 5722 0576
    Mobile: +98 915 324 2998
    Fax:
    Email: ‪Ansari.fatemeh5961@gmail.com‬‏
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Iman Ghorbani Moghaddam
    Full name of responsible person - Persian: ایمان قربانی مقدم
    Position - English: Student Bachelor of Nursing
    Position - Persian: دانشجو کارشناسی پرستاری
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Student Research Committee, Gonabad University of Medical Sciences, Asian Road Margin
    Street address - Persian: حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد، کمیته تحقیقات دانشجویی
    City - English: Gonabad
    City - Persian: گناباد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9691647161
    Phone: +98 51 5722 0576
    Mobile: +98 930 239 2707
    Fax:
    Email: ghorbani.i@gmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fatemeh Ansari
    Full name of responsible person - Persian: فاطمه انصاری
    Position - English: MSc of Nursing
    Position - Persian: کارشناسی ارشد پرستاری
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Student Research Committee, Gonabad University of Medical Sciences, Asian Road Margin
    Street address - Persian: حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد، کمیته تحقیقات دانشجویی
    City - English: Gonabad
    City - Persian: گناباد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9691647161
    Phone: +98 51 5722 0576
    Mobile: +98 915 324 2998
    Fax:
    Email: ‪Ansari.fatemeh5961@gmail.com‬‏
    Web page address:

Protocol summary

Study aim
The effect of topical heat therapy on shoulder pain after laparoscopic gallbladder surgery
Design
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
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Shoulder pain severity

General information

Reason for update
Acronym
IRCT registration information
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
Registration date
2019-12-13, 1398/09/22
Registrant information
Name
Iman Ghorbany Moghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 0576
Email address
ghorbani.i@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2019-02-04, 1397/11/15
Actual recruitment end date
2019-09-12, 1398/06/21
Trial completion date
2019-09-23, 1398/07/01
Scientific title
Effect of Local Heat Therapy on Shoulder Pain of after Laparascopic Cholecystectomy
Public title
Effect of Local Heat Therapy on Shoulder Pain of after Laparascopic Cholecystectomy
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Gonabad University of Medical Sciences
Street address
Asian Road Rim, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
96916-47161
Approval date
2018-11-22, 1397/09/01
Ethics committee reference number
IR.GMU.REC.1397.091

Health conditions studied

1

Description of health condition studied
cholecystectomy
ICD-10 code
K91.86
ICD-10 code description
Retained cholelithiasis following cholecystectomy

Primary outcomes

1

Description
Severity of shoulder pain after laparoscopic cholecystectomy
Timepoint
Before intervention, 20 and 40 minutes after intervention
Method of measurement
Pain severity was measured using the Visual Analogue Scale.

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Other

2

Description
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.
Category
Other

3

Description
Control group: For the research units in this group only routine care was performed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Allameh Bohlol Hospital, Gonabadi
Full name of responsible person
Dr. Abbas Ebadi
Street address
Parastar Blvd
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0576
Email
info@gmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Javad Bazli
Street address
Asian Road Rim, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0576
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Ansari
Position
MSc of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Student Research Committee, Gonabad University of Medical Sciences, Asian Road Margin
City
Gonabad
Province
Razavi Khorasan
Postal code
9691647161
Phone
+98 51 5722 0576
Email
‪Ansari.fatemeh5961@gmail.com‬‏

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Ansari
Position
MSc of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Student Research Committee, Gonabad University of Medical Sciences, Asian Road Margin
City
Gonabad
Province
Razavi Khorasan
Postal code
9691647161
Phone
+98 51 5722 0576
Email
‪Ansari.fatemeh5961@gmail.com‬‏

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Ansari
Position
MSc of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Student Research Committee, Gonabad University of Medical Sciences, Asian Road Margin
City
Gonabad
Province
Razavi Khorasan
Postal code
9691647161
Phone
+98 51 5722 0576
Email
‪Ansari.fatemeh5961@gmail.com‬‏

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
After receiving the results of the decision for the publication, I will produce results.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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