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Comparison Of The Effects Of Skin Pulling, Pressure And Quick Release Of Muscle By Conventional Method On Pain Induced By Intramuscular Injection.

Protocol summary

Study aim
The Purpose Of This Study Was To Determine The Effect Of Using Stretching On The Skin, Pressure And Rapid Release Of Muscle To Reduce Injection Pain Compared With Standard Injection Methods.
Design
This Study Is Done On 28 Patients Taking Metocarbamol And Have Entry Requirements. For The Patient, Two Injections Of 5 Cc Will Be Done In Conventional And Innovative Manner. Random Assignments Will Be Made By Tap And Line For Example, In The Dorsogluteal Muscle Of The Right Is A Common Injection And Inventive In The Dorsogluteal Muscle Of The Left. And In The Next, The Sequence Is Change.
Settings and conduct
This Study Is A Triple Blind Clinical Trial That Will Be Carried Out At Vasei Hospital, Unit Of Injection, At Vasei Hospital. Each Patient Will Experience Two Injection Methods. In This Study, The Patient, The Pain Assessor And The Statistical Analyst Of How To Do The Injection Are Unaware.
Participants/Inclusion and exclusion criteria
Entry Criteria For Sampling Including Ages 16 To 60, Lack Of Communication Problems Such As Auditory, Visual, Speech And Common Language, The Same Volume In The Patient's Dorsogluteal Muscles And Having Written Consent, Two Healthy Muscles, And No Sensory Problem Have Two Equal Volume Muscles And Non-Inclusion Criteria Include Scarring, Redness, Bruising, Sensitivity And Stiffness At The Injection Site, History Of Injection In The Past Two Weeks, Neuropathy, Severe Pain Due To Illness And Severe Fear Of Injection, Individuals With BMI Below 15 And Over 35, Drug Use Was A History Of Diabetes.
Intervention groups
This Study Has Two Groups Which For Each Patient, There Are Two Common And Innovative Methods
Main outcome variables
Pulling The Skin, Pressure And Quick Release Of The Muscle

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171231038155N1
Registration date: 2018-01-29, 1396/11/09
Registration timing: retrospective

Last update: 2018-01-29, 1396/11/09
Update count: 0
Registration date
2018-01-29, 1396/11/09
Registrant information
Name
Maryam Salary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 8905
Email address
salarym94@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-10, 1396/10/20
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of The Effects Of Skin Pulling, Pressure And Quick Release Of Muscle By Conventional Method On Pain Induced By Intramuscular Injection.
Public title
Influence Of Pressure And Rapid Release Of Muscle On The Pain Caused By Muscle Intramuscular Injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The Criteria For Entering The Research Include Ages 16 To 60 The Lack Of Communication Problems Such As Hearing, Visual, Speech And Common Language The Same Volume In The Patient's Dorsogluteal Muscle Having Written Consent
Exclusion criteria:
Having Scar, Redness, Bruising, Sensitivity And Stiffness At The Injection Site, Neuropathy Having A History Of Injections In The Last Two Weeks Severe Pain Caused By The Disease Severe Fear Of Injection
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 28
More than 1 sample in each individual
Number of samples in each individual: 2
For Each Patient On Dorsogluteal Muscles, Two Conventional And Inventine Injections Are Performed.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
In This Study, All Injections Were Performed By A Qualified Nurse. Participants Were Unaware Of The Injection Method And After Injection, The Pain Assessment Was Done By Another Nurse Who Was Also Unaware Of The Injection Method. Finally, The Statistical Analyst Did Not Know How To Inject, So That Injections A And B Were Delivered To The Statistician.
Placebo
Not used
Assignment
Parallel
Other design features
Considering That This Study Examines The Effect Of Skin Pulling, The Pressure And Quick Release Of Muscle On The Pain Caused By Muscle Injections, This Method Is The First One To Be Done, And It May Be Hard To Understand How This Method Is For The Readers. A Brief Video Of How To Inject Should Be Attached To The Article.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Abu Mosalm Street -Abu Moslem 8th , No. 14
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619614479
Approval date
2017-12-11, 1396/09/20
Ethics committee reference number
IR.MEDSAB.REC.1395.141

Health conditions studied

1

Description of health condition studied
Pain Caused By Muscle Transfusion
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
In This Study, The Pain After Each Injection Is Evaluated Using VAS, So That Each Patient Is Dosed Twice And Immediately After Each Injection, And The Distance Between The Two Injections In Each Patient Is Just As Much As The Pain Questionnaire.
Method of measurement
VAS

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: Injection By Inventive Method (Pulling Skin, Pressure And Rapid Release Of Muscle) After Dragging And Applying Deep Pressure With The Needle Entry At 90 °, The Muscle Quickly Released And Injection After Aspiration At 1 Cc In 10 Seconds To Be In This Method, The Actual Release Of The Muscle Causes The Needle To Enter, And The Needle Movement Is Inactive By The Dominant Hand And The Main Role Is To Remove The Pressure From The Muscle By The Non-Dominant Hand. All Injections Were Performed Using A 5-cc Syringe With A Needle Number 22Mm, And The Air Locking Technique Was Performed With Two 0.2cc In All Injections. The Use Of Alcohol-Impregnated Cotton Was Used To Sterilize Injection Site. Meanwhile, A Gap Was Not Considered Between The Two Injections Except The Completion Of The Pain Assessment Questionnaire. Control Group: In The Conventional Injection Method, The Pressure Was Not Applied And After Pulling The Skin Between The Fingers And The Needle Pointed In A Dart Manner With A 90 Degree Angle Entered And After Aspiration, Injected At 1Cc In 10 Seconds
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان واسعی
Full name of responsible person
مریم سالاری
Street address
سبزوار بیمارستان واسعی راه شهرک توحید
City
Sabzevar
Province
Razavi Khorasan
Postal code
6919614479
Phone
+98 51 4464 8905
Email
elham.salary77@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
دکتر فرشته قراط
Street address
سبزوار - بلوار شهدای هسته ای- بالاتر از مزار شهدای گمنام -پردیس دانشگاه علوم پزشکی سبزوار - معاونت تحقیقات و فناوری
City
Sabaevar
Province
Razavi Khorasan
Postal code
9619614479
Phone
+98 51 4401 8319
Fax
+98 51 4401 8319
Email
elham.salary77@gmail.com
Web page address
https://www.google.com
Grant name
-222
Grant code / Reference number
12
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
maryam salary
Position
Student of Internal and Surgical Masters
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Abu Mosalm Street - Abu Mosalm 8 -Plat 14
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619614479
Phone
+98 51 4464 8905
Email
elham.salary77@gmail.com
Web page address
https://www.google.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
maryam salary
Position
Student of Internal and Surgical Masters
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Abu Mosalm Street - Abu Mosalm 8 -Plat 14
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619614479
Phone
+98 51 4464 8905
Email
elham.salary77@gmail.com
Web page address
https://www.google.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
maryam salary
Position
Student of Internal and Surgical Masters
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Abu Mosalm Street - Abu Mosalm 8 - 14th Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619614479
Phone
+98 51 4464 8905
Email
elham.salary77@gmail.com
Web page address
https://www.google.com

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
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