History
# Registration date Revision Id
2 2020-03-15, 1398/12/25 128923
1 2018-09-29, 1397/07/07 61209
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  • Protocol summary

    Clinical practice with two intervention groups And a community-based, action-oriented control group with Factorial groups , One-sided blind, randomized with permutation blocks
    A clinical trial with a control group, with parallel groups, without blinding, randomized
    کارازمایی بالینی دارای دو گروه مداخله و یک گروه کنترل، مبتنی بر جامعه و عمل گرا با گروه های فاکتوریال، یک سو کور، تصادفی شده با بلوک های جایگشتی
    کارازمایی بالینی دارای گروه کنترل، با گروه های موازی، بدون کورسازی، تصادفی شده
    Implementation of the study in the injections section of Vasei Hospital in Sabzevar، Available sampling،Allocation of random groups of permutable blocks،Then the Selection site of injection and injection was the standard protocol Then the intensity of the injection pain is measured.
    Implementation of the study in the injections section of Vasei Hospital in Sabzevar. The exact location of ventrogluteal and dorsogluteal (DG) sites was determined using V and square method respectively.
    اجرا مطالعه در بخش تزریقات بیمارستان واسعی سبزوار، نمونه گیری به صورت در دسترس، تخصیص گروها به صورت تصادفی بابلوک ها جایگشتی، سپس انتخاب محل تزریق و انجام تزریق با پروتکل استاندارد طراحی شده، سپس شدت درد تزریق اندازگیری می شود.
    مطالعه در بخش تزریقات بیمارستان واسعی سبزوار انجام شد. محل دقیق تزریق در ونتروگلوتئال و دورسوگلوتئال به ترتیب بر مبنای روش V و روش مربع صورت گرفت.
    Group 1: Injection site based on anthropometric algorithm Then the intensity of the injection pain is measured. Group 2: The injection site is selected based on the body shape pattern Then the intensity of the injection pain is measured. Group 3: Selection of injection site with traditional method Then the intensity of the injection pain is measured.
    1) in the control group all patients received dorsogluteal injection (traditional way). 2) in the anthropometric group, the algorithm presented by Larkin et al. was used to select the site of gluteal injection based on sex, weight, BMI, waist circumference (WC) and anterior superior iliac spine to iliac tubercle (ASIS-IT) 3) in the body shape pattern group, the algorithm presented by Larkin et al. was used to select the site of gluteal injection based on observed body shape indices (OBS), BMI and gender.
    گروه اول: مکان تزریق براساس الگوریتم آنتروپومتریک انتخاب و سپس شدت درد تزریق اندازه گیری می شود. گروه دوم: مکان تزریق براساس الگوی شکل بدن انتخاب و سپس شدت درد تزریق محاسبه می شود. گروه سوم:مکان تزریق با روش سنتی انتخاب و سپس شدت درد تزریق محاسبه می شود.
    گروه اول: مکان تزریق مکان تزریق با روش سنتی (دورسوگلوتئال) انتخاب شد. گروه دوم: محل تزریق براساس الگوریتم آنتروپومتریک لارکین و همکاران (بر اساس چنس، وزن، شاخص توده بدنی، دور کمر و فاصله برجستگی فوقانی قدامی خارخاصره تا خارخاصره) انتخاب شد. گروه سوم: مکان تزریق براساس الگوی شکل بدن توصیف شده توسط لارکین و همکاران (بر اساس شکل بدن مشاهده شده، شاخص توده بدنی و جنس) انتخاب شد.
    intensity pain intramuscular injection
    severity of intramuscular injection pain
  • General information

    Single blinded
    Not blinded
    1
    Single
    Parallel
    Other
    Treatment
    empty
    162
    empty
    2018-10-27, 1397/08/05
    empty
    2018-12-31, 1397/10/10
    empty
    2018-12-31, 1397/10/10
    empty
    After an epidemiologist was added to the research team, the study design changed briefly. Therefore, the corrections made to the study were updated
    empty
    با توجه به اضافه شدن یک اپیدمیولوژیست به تیم تحقیق، طراحی مطالعه مختصری تغییر کرد. بنابراین اصلاحات رخ داده در مطالعه بروزرسانی گردید.
    The effect site selection on pain intensity of intramuscular injection
    Does selecting the site of injection based on anthropometric indices and body shape reduces the pain of injection?
    تاثیر انتخاب محل بر شدت درد تزریق عضلانی
    انتخاب محل تزریق عضلانی بر اساس شاخص های آنتروپومتریک و شکل بدن درد تزریق عضلانی را کاهش می دهد؟
    بررسی مقایسهای تأثیر انتخاب محل تزریق عضلانی براساس شاخص های آنتروپومتریک، دموگرافیک و شکل بدن بر درد ناشی از تزریق
    بررسی مقایسه ای تأثیر انتخاب محل تزریق عضلانی براساس شاخص های آنتروپومتریک، دموگرافیک و شکل بدن بر درد ناشی از تزریق
    Having very severe pain due to the disease
    Having a physical (motor or sensory) problem
    Toughness and tenderness and pain at the injection site
    Having a former injection site in the last two weeks
    History of mental illness, diabetes and light-headedness
    Having very severe pain due to the disease
    Having a physical (motor or sensory) problem
    Toughness and tenderness and pain at the injection site
    Having a former injection site in the last two weeks
    Patients with psychopathy, diabetes,neuropathy, delirium, dementia, coagulopathy, and those had an extreme fear of injections
    Use of opiate or non-opiate analgesics 6 hours before enrollment
    داشتن درد بسیار شدید ناشی از بیماری
    داشتن مشکل جسمی(حسی یا حرکتی)
    سفتی و حساسیت و درد در محل تزریق
    سابق تزریق در محل در دو هفته گذشته
    سابقه بیماری روانی، دیابت و نورپاتی
    داشتن درد بسیار شدید ناشی از بیماری
    داشتن مشکل جسمی (حسی یا حرکتی)
    سفتی و حساسیت و درد در محل تزریق
    سابق تزریق در محل در دو هفته گذشته
    سابقه بیماری روانی، دیابت، نورپاتی، دلیریوم، دمانس، بیماری های انعقادی و ترس بسیار زیاد از تزریق
    مصرف مسکن مخدر یا غیرمخدر 6 ساعت قبل از ورود به مطالعه
    empty
    Three group randomized controlled clinical trial study
    empty
    کارآزمایی بالینی سه گروهه
    Simple random sampling method, the method of assigning patients to permutational block using statistical software
    Enrolled subjects were randomly assigned to a 1:1 ratio using a web-based random allocation system in undisclosed block sizes of six. There were 168 sequentially numbered opaque sealed envelopes (SNOSE) that contained a group assignment for the subjects. The envelopes were shuffled and distributed to each subject. The registered nurse chose the method of injection after opening the undisclosed envelope.
    روش نمونه گیری تصادفی ساده، روش انتساب بیماران بلوک جایگشتی با استفاده از نرم افزار آماری
    مشارکت کنندگان به طور تصادفی به نسبت 1:1 با استفاده از یک سیستم اختصاصی تصادفی مبتنی بر وب در بلوک های شش تایی قرار گرفتند. 168 پاکت نامه مهر و موم شده، مات با شماره متوالی وجود داشت که شامل نحوه ی قرار گرفتن افراد در گروه مداخله بود. پاکت های نامه پس از هم زدن بین افراد توزیع شد. پرستار پس از باز كردن پاكت نامه، روش تزريق را انتخاب می كرد.
    participants
    شرکت کنندگان
  • Health conditions studied

    #1
    empty
    pain of intramuscular injection
    empty
    درد تزریق عضلانی
    #2
    intramuscular injection
    empty
    تزریق عضلانی
    empty
  • Primary outcomes

    #1
    empty
    severity of pain after intramuscular injection in gluteal muscles
    empty
    شدت درد ناشی از تزریق در عضلات گلوتئالی
    empty
    After injection
    empty
    پس از تزریق
    empty
    The Visual Analogue Scale (VAS)
    empty
    با استفاده از مقیاس دیداری (VAS) درد
    #2
    intensity pain intramuscular injection
    empty
    شدت درد تزریق عضلانی
    empty
    During injection and immediately after injection
    empty
    حین تزریق و بلافاصله پس از تزریق
    empty
    Visual Analogue Scale
    empty
    مقیاس آنالوگ دیداری
    empty
  • Intervention groups

    #1
    Control group: Select the injection site with the traditional method
    Control group: Injection in the dorsogluteal position
    گروه کنترل: انتخاب محل تزریق با روش سنتی
    گروه کنترل: انجام تزریق در موقعیت دورسوگلوتئال
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Fereshteh Gharat
    Full name of responsible person - Persian: دکتر فرشته قراط
    Street address - English: Vassie Hospital, Nuclear Martyrs Blvd
    Street address - Persian: بیمارستان واسعی، بلوار شهدای هسته ای
    City - English: Sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9617747431
    Phone: +98 51 4465 1300
    Fax:
    Email: khosrojerdiA95@medsab.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: حمایت مالی نشده است
    Name of organization / entity - Persian: No funding
    Full name of responsible person - English: Abdolghader Assarroudi
    Full name of responsible person - Persian: عبدالقادر عصاررودی
    Street address - English: Department of Medical-Surgical Nursing, Sabzevar School of Nursing, Sabzevar University of Medical Sciences Campus, Tohid Shahr Blvd., Sabzevar, Razavi Khorasan Province, Iran
    Street address - Persian: پردیس دانشگاه علوم پزشکی سبزوار
    City - English: Sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9613873136
    Phone: +98 51 4401 8371
    Fax:
    Email: ghaderassar@yahoo.com
    Web page address:
    Yes
    empty
    Public
    Private
    Academic
    Persons
    Sabzevar University of Medical Sciences
    The authors received no financial support for the research, authorship, and/or publication of this article.
    دانشگاه علوم پزشکی سبزوار
    بودجه شخصی
  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Abdul Ghader Assarroudi
    Full name of responsible person - Persian: عبدالقادر عصاررودی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Sabzevar University of Medical Sciences
    Street address - Persian: دانشگاه علوم پزشکی سبزوار
    City - English: Sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9617913114
    Phone: +98 51 4401 1014
    Mobile: +98 915 321 1068
    Fax:
    Email: khosrojerdiA95@medsab.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Abdolghader Assarroudi
    Full name of responsible person - Persian: عبدالقادر عصاررودی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Sabzevar University of Medical Sciences
    Street address - Persian: دانشگاه علوم پزشکی سبزوار
    City - English: سبزوار
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9617913114
    Phone: +98 51 4401 1014
    Mobile: +98 915 321 1068
    Fax:
    Email: ghaderassar@yahoo.com
    Web page address: http://isid.research.ac.ir/Abdolghader_Assarroudi

Protocol summary

Study aim
Determining thethe effect of intramuscular injection site selection according to anthropometric and demographic body shape assessment methods on pain injection Comparison of the severity of injection pain in two methods of selecting an injection site based on anthropometric and demographic indicators with body shape, body mass index and sex
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized
Settings and conduct
Implementation of the study in the injections section of Vasei Hospital in Sabzevar. The exact location of ventrogluteal and dorsogluteal (DG) sites was determined using V and square method respectively.
Participants/Inclusion and exclusion criteria
Problems in communicating, cognitive problems, having sensory or motor problems, stiffness and sensitivity or history of injection in the site and history of mental illness, diabetes and Norpathy prevents people from entering the study
Intervention groups
1) in the control group all patients received dorsogluteal injection (traditional way). 2) in the anthropometric group, the algorithm presented by Larkin et al. was used to select the site of gluteal injection based on sex, weight, BMI, waist circumference (WC) and anterior superior iliac spine to iliac tubercle (ASIS-IT) 3) in the body shape pattern group, the algorithm presented by Larkin et al. was used to select the site of gluteal injection based on observed body shape indices (OBS), BMI and gender.
Main outcome variables
severity of intramuscular injection pain

General information

Reason for update
After an epidemiologist was added to the research team, the study design changed briefly. Therefore, the corrections made to the study were updated
Acronym
IRCT registration information
IRCT registration number: IRCT20180826040875N1
Registration date: 2018-09-29, 1397/07/07
Registration timing: prospective

Last update: 2020-04-10, 1399/01/22
Update count: 1
Registration date
2018-09-29, 1397/07/07
Registrant information
Name
Azam Khosrojerdy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4429 6339
Email address
khosrojerdia95@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-22, 1397/07/30
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-10-27, 1397/08/05
Actual recruitment end date
2018-12-31, 1397/10/10
Trial completion date
2018-12-31, 1397/10/10
Scientific title
A comparative study on the effect of intramuscular injection site selection according to anthropometric and demographic body shape assessment methods on pain injection
Public title
Does selecting the site of injection based on anthropometric indices and body shape reduces the pain of injection?
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants in the research have written consent There is no problem communicating (example: hearing, vision, speech, common language) At least 18 years old and maximum 65 years
Exclusion criteria:
Having very severe pain due to the disease Having a physical (motor or sensory) problem Toughness and tenderness and pain at the injection site Having a former injection site in the last two weeks Patients with psychopathy, diabetes,neuropathy, delirium, dementia, coagulopathy, and those had an extreme fear of injections Use of opiate or non-opiate analgesics 6 hours before enrollment
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 162
Actual sample size reached: 162
Randomization (investigator's opinion)
Randomized
Randomization description
Enrolled subjects were randomly assigned to a 1:1 ratio using a web-based random allocation system in undisclosed block sizes of six. There were 168 sequentially numbered opaque sealed envelopes (SNOSE) that contained a group assignment for the subjects. The envelopes were shuffled and distributed to each subject. The registered nurse chose the method of injection after opening the undisclosed envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Three group randomized controlled clinical trial study

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Vasei Hospital, Nuclear Martyrs Blvd
City
Khorasan Razavi
Province
Razavi Khorasan
Postal code
9617747431
Approval date
2018-09-24, 1397/07/02
Ethics committee reference number
IR.MEDSAB.REC.1397.037

Health conditions studied

1

Description of health condition studied
pain of intramuscular injection
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
severity of pain after intramuscular injection in gluteal muscles
Timepoint
After injection
Method of measurement
The Visual Analogue Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Selection of injection site using an algorithm extracted from demographic and anthropometric indices
Category
Treatment - Other

2

Description
Intervention group: Selection injection site with body shape pattern and demographic indicators
Category
Treatment - Other

3

Description
Control group: Injection in the dorsogluteal position
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei Hospital in Sabzevar
Full name of responsible person
Azam Khosrojerdy
Street address
Nuclear Martyrs Blvd, Vassie Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Email
khosrojerdiA95@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
حمایت مالی نشده است
Full name of responsible person
Abdolghader Assarroudi
Street address
Department of Medical-Surgical Nursing, Sabzevar School of Nursing, Sabzevar University of Medical Sciences Campus, Tohid Shahr Blvd., Sabzevar, Razavi Khorasan Province, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8371
Email
ghaderassar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The authors received no financial support for the research, authorship, and/or publication of this article.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Azam Khosrojerdy
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vassie Hospital, Nuclear Martyrs Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747131
Phone
+98 51 4465 1300
Email
khosrojerdiA95@medsab.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Abdolghader Assarroudi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sabzevar University of Medical Sciences
City
سبزوار
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1014
Email
ghaderassar@yahoo.com
Web page address
http://isid.research.ac.ir/Abdolghader_Assarroudi

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Azam Khosrojerdy
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vassie Hospital, Nuclear Martyrs Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Email
khosrojerdiA95@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
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