Assessment the effect of incentive spirometry on intensity of shoulder pain after laparoscopic Cholecystectomy surgery in Mashhad medical sciences University Hospitals In the year 2018
The effect of incentive spirometry on intensity of shoulder pain after laparoscopic Cholecystectomy surgery.
Design
Clinical trial with intervention and control group، community based and pragmatic،one blinded، randomized with permutation blocks
Settings and conduct
Research in hospitals affiliated to Mashhad University of Medical Sciences and individuals are sampled according to criteria. Motivating spirometriy training Before surgery and after surgery and consciousness, the patient is asked to take 10 breaths (inside the tube and exhalation in the open air) every 2 hours to 12 hours. The shoulder pain should be measured at 4.8, 12.24, and 48 hours later.
Participants/Inclusion and exclusion criteria
Age between 18 and 65،full satisfaction،cholecystitis diagnosis,full consciousness, located under General anesthesia and having pain in one or both shoulders:having mental illness and anxiety disorders, having Underlying diseases such as respiratory diseases,history of addiction to any substance drugs and cigarettes,history of diabetes and neuropathy ،pregnancy,there is any shoulders disorder
Intervention groups
The control group receives the medication according to the prescribing physician. The intervention group receives a motile spirometry.
Main outcome variables
Effect of on shoulder pain after laparoscopic cholecystectomy with non-pharmacological and low-cost technique; Effect on surgical pulmonary complications and improvement of respiratory function in patients undergoing laparoscopic cholecystectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181106041569N1
Registration date:2018-11-24, 1397/09/03
Registration timing:prospective
Last update:2018-11-24, 1397/09/03
Update count:0
Registration date
2018-11-24, 1397/09/03
Registrant information
Name
Mehri sadat Saremi rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 1416
Email address
smirad1992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-01, 1397/09/10
Expected recruitment end date
2019-03-30, 1398/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of incentive spirometry on intensity of shoulder pain after laparoscopic Cholecystectomy surgery in Mashhad medical sciences University Hospitals In the year 2018
Public title
The Effect of Motivational Spirometry on Shoulder Pain After Laparoscopic Laparoscopic Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years
Have complete satisfaction to participate in research
Have at least reading and writing skills
Diagnosis of cholecystitis based on sonography and general surgeon's opinion
Complete vigilance
Patients undergoing laparoscopic cholecystectomy
Subjects under general anesthesia (for all patients with anesthetic drugs) miazolam and atracurium ampoules for total muscle relaxation as a pre-operative drug
Ampoules Nesodnal is used as an anesthetic for patients during surgery, then co2 gas is injected to 8 mm Hg pressure in the patient's abdomen
Having pain in one or both shoulders
Exclusion criteria:
Having known psychological illnesses and anxiety disorders
Previous history of laparoscopic surgery
Having underlying illnesses like COPD and respiratory diseases
A history of addiction to any drug or cigarette
History of the use of motivational spirometry
A history of diabetes and neuropathy
Pregnancy
There is any disorder in the shoulders
Emergency patient conditions for laparoscopic cholecystectomy
Surgical history
Duration of surgery for more than 2 hours
Injection of drugs out of the prescribed anesthetic protocol
Patients who need to have NGT after surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Optionally available and randomly block permutations
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome evaluators are blind in this study, since they do not have any information about the intervention and control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Shahrak Tohid Blvd, Block 1,Sabzevar University Of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Approval date
2018-11-04, 1397/08/13
Ethics committee reference number
IR.MEDSAB.REC.1397.055
Health conditions studied
1
Description of health condition studied
Shoulder pain after laparoscopic Cholecystectomy surgery
ICD-10 code
Z90.4
ICD-10 code description
Acquired absence of other specified parts of digestive tract
Primary outcomes
1
Description
The percentage of patients undergoing laparascopic cholecystectomy after shoulder pain
Timepoint
Severe shoulder pain after 4.8.12,24 and 48 hours to be measured
Method of measurement
Pain measurement tool (questionnaire)
Secondary outcomes
1
Description
Incentive spirometry
Timepoint
From 2 hours after surgery of both the morning and afternoon shifts at two hours (12 hours)
Method of measurement
Observation
Intervention groups
1
Description
Control group: Receives analgesic drugs according to the protocol. Patients receive Non_steroidal Anti inflammatory Drug after surgery.
Category
Prevention
2
Description
Intervention group: receptor spirometry. The patient is given necessary training before surgery and after 2 hours of surgery and alertness the patient is asked to do it for up to 12 hours every two hours. The patient's pain is measured at 4.8.12.24 and 48 hours later with a pain measuring instrument. For each patient, one Oral tube is used separately.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza and Omid Hospitals
Full name of responsible person
Mehri Sadat Saremi Rad
Street address
Kohsangi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3726 9021
Email
emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Doctor Fereshteh Ghorat
Street address
Shahrak Tohid Blvd, Block 1, Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Phone
+98 51 4401 1060
Email
ghoratf@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mehri Sadat Saremi Rad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.24, Modares 20 Ave.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617753544
Phone
+98 51 4422 1416
Email
saremi95@medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Hamideh Yazdi
Position
PhD in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrak Tohid Blvd, University of Medical Sience
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Phone
+98 51 4401 1000
Email
yazdih@medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mehri Sadat Saremi Rad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.24 , Modares 20 Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617753544
Phone
+98 51 4422 1416
Email
saremi95@medsab.ac.ir
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