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Comparison of the effectiveness of Xyla-p and cold needle cream on fear and pain during venipuncture in children under chemotherapy

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History
# Registration date Revision Id
2 2024-11-28, 1403/09/08 359782
1 2021-11-06, 1400/08/15 204387
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  • Protocol summary

    In cold angiocat injection: Place the angiocatheter in a refrigerator-freezer at -20 ° C for at least one hour in a steel box. After identifying the target vein, the angiocatheter is immediately removed from the freezer and a venipuncture is performed. For injection with Xylapi cream: Apply 2.5 grams of xylophone cream on the skin and apply it on 25-20 cm2 of the skin and cover it with a nylon dressing for at least 45 minutes, then perform a venipuncture with an angiocatheter that is kept in room air. complications such as skin allergies.
    This double-blind, parallel-group randomized controlled trial included 87 children aged 2–6 years undergoing outpatient chemotherapy in Mashhad, Iran. Participants were randomized into four groups: control (routine care), cold angiocath, Xylap cream, and combination. Pain intensity and fear were assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) and Children’s Fear Scale (CFS), respectively, across four venipuncture sessions (one baseline, three intervention).
    در تزریق با آنژیوکت سرد:آنژیوکت را در یخچال فریزر با دمای 20- درجه سانتیگراد به مدت حداقل یک ساعت درون یک بیکس استیل قرار می دهیم. پس از مشخص کردن ورید موردنظر، آنژیوکت بلافاصله از فریزر خارج می گیرد و رگ گیری انجام می­ شود. در تزریق با کرم زایلاپی: 2/5 گرم کرم زایلاپی را روی پوست قرار داده و بر روی 25 - 20 سانتی متر مربع از پوست آغشته و با پانسمان نایلونی روی آن را حداقل به مدت 45 دقیقه می پوشانیم سپس رگ گیری با آنژیوکت که در هوای اتاق نگهداری شده است انجام می گیرد.
    این کارآزمایی تصادفی کنترل‌شده دوسوکور با گروه‌های موازی شامل ۸۷ کودک ۲ تا ۶ ساله تحت شیمی‌درمانی سرپایی در مشهد، ایران بود. شرکت‌کنندگان به صورت تصادفی به چهار گروه تقسیم شدند: کنترل (مراقبت‌های معمول)، آنژیوکت سرد، کرم زایلاپ و ترکیبی. شدت درد و ترس به ترتیب با استفاده از مقیاس‌های صورت، پاها، فعالیت، گریه، تسلی‌پذیری (FLACC) و مقیاس ترس کودکان (CFS) در چهار جلسه رگ‌گیری (یک جلسه پایه، سه جلسه مداخله) ارزیابی شدند.
    شرایط ورود: سن 6-2سال،داشتن هوشیاری کامل، عدم دریافت داروهای ضد درد، سداتیو، دریافت داروی شیمی درمانی به صورت هفتگی،گذشت حداقل یک ماه از شروع بیماری بود. معیارهای عدم ورود به مطالعه عدم موفقیت برای تعبیه خط وریدی با یک بار وارد کردن آنژیوکت به پوست و نیاز به کوشش مجدد
    شرایط ورود: سن 6-2سال، داشتن هوشیاری کامل، عدم دریافت داروهای ضد درد، سداتیو، دریافت داروی شیمی درمانی به صورت هفتگی، گذشت حداقل یک ماه از شروع بیماری بود. معیارهای عدم ورود به مطالعه عدم موفقیت برای تعبیه خط وریدی با یک بار وارد کردن آنژیوکت به پوست و نیاز به کوشش مجدد
    در هفته اول به عنوان جمع آوری اطلاعات پایه، تزریق در حالت روتین انجام می گردد یعنی بدون هیچ گونه کرم و آنژیوکت با سوزن در دمای اتاق. در هفته های بعدی در 3 نوبت تزریق به یک شیوه از 4 روش مذکور (گروه اول کرم زایلاپی و آنژیوکت سرد، گروه دوم انژیوکت با سوزن سرد و کرم مرطوب کننده، گروه سوم کرم زایلاپی و آنژیوکت با دمای اتاق، گروه چهارم کرم مرطوب کننده و آنژیوکت با سوزن در دمای اتاق. ) انجام خواهد شد. بنابراین مداخله و جمع آوری داده ها در هر کودک در 4 نوبت سنجش می گردد.
    در هفته اول به عنوان جمع آوری اطلاعات پایه، تزریق در حالت روتین انجام می گردد یعنی بدون هیچ گونه کرم و آنژیوکت با سوزن در دمای اتاق. در هفته های بعدی در 3 نوبت تزریق به یک شیوه از 4 روش مذکور (گروه اول کرم زایلاپی و آنژیوکت سرد، گروه دوم انژیوکت با سوزن سرد و کرم مرطوب کننده، گروه سوم کرم زایلاپی و آنژیوکت با دمای اتاق، گروه چهارم کرم مرطوب کننده و آنژیوکت با سوزن در دمای اتاق) انجام خواهد شد. بنابراین مداخله و جمع آوری داده ها در هر کودک در 4 نوبت سنجش می گردد.
    Pain
    Pain; Fear
    شدت درد
    ترس و درد

  • General information

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    2021-11-13, 1400/08/22
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    2023-02-26, 1401/12/07
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    2023-02-26, 1401/12/07
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    The fear variable was initially measured because it was considered a confounding variable to estimate the effect of this confounder on the study results. Then, it was decided that reporting this variable as a dependent variable could provide more information (the effect of independent variables on pain as well as fear) to the readers of the article.
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    در ابتدا متغیر ترس به دلیل درنظر گرفتن آن به عنوان متغیر مخدوش گر و براورد اثر این مخدوش گر بر نتایج مطالعه اندازه گیری شد. در ادامه و در جریان جمع آوری و تحلیل داده، تصمیم بر این شد که گزارش این متغیر به عنوان متغیر وابسته می تواند اطلاعات بیشتری را (اثر متغیرهای مستقل بر درد و همچنین ترس) در اختیار خوانندگان مقاله قرار دهد.
    Comparison of the effectiveness of Xyla-p and cold needle cream on pain intensity
    Comparison of the effectiveness of Xyla-p and cold needle cream on fear and pain
    مقایسه اثربخشی کرم زایلاپی و سرسوزن سرد بر شدت درد
    مقایسه اثربخشی کرم زایلاپی و سرسوزن سرد بر ترس و درد
    Comparison of the effectiveness of Xyla-p and cold needle cream on pain intensity during venipuncture in children under chemotherapy
    Comparison of the effectiveness of Xyla-p and cold needle cream on fear and pain during venipuncture in children under chemotherapy
    مقایسه اثربخشی کرم زایلاپی و سرسوزن سرد بر شدت درد مرتبط با ورود کاتتر داخل وریدی در کودکان تحت شیمی درمانی
    مقایسه اثربخشی کرم زایلاپی و سرسوزن سرد بر ترس و درد مرتبط با ورود کاتتر داخل وریدی در کودکان تحت شیمی درمانی
    restless children
    the children with loss of consciousness
    children receive sedative or analgesic
    children with a history of sensitivity to lidocaine.
    Restless children
    The children with loss of consciousness
    Children receive sedative or analgesic
    Children with a history of sensitivity to lidocaine.
    80 patients are selected as simple access based on inclusion and exclusion criteria and then are randomly assigned to 4 groups using 4 random blocks. Random allocation of the subjects will done by using a block random sampling; A: Xyla-p cream and cold needle Angiocatheter,‎ B: Moisturizing cream and cold needle Angiocatheter‎, C: Xyla-p cream and Angiocatheter in room temperature, D: Moisturizing cream and Angiocatheter in room temperature. Blocks will be ABCD,BCDA,CDBA,CDAB,DACB. The order of blocks will be simple randomized.
    Randomization was performed using a computer-generated random list with permuted blocks of size eight, prepared by an independent statistician. Allocation was concealed using 88 sequentially numbered, opaque, sealed envelopes, opened at the time of assignment.
    80 واحد پژوهش به صورت دسترسی ساده بر اساس معیارهای ورود و خروج انتخاب و سپس با استفاده از بلوک های تصادفی 4 تایی به صورت تخصیص تصادفی در 4 گروه قرار می گیرند. تخصیص بیماران در گروه های درمانی به صورت تصادفی با استفاده از بلوک بندی با بلوک های چهارتایی در یکی از گرو ه های درمانی ‏خواهد بود؛‏ A‏- گروه زایلاپی و آنژیوکت با سوزن سرد( گروه مداخله)‏ B‏ -گروه کرم مرطوب کننده و آنژیوکت با سوزن سرد. C گروه کرم زایلاپی و آنژیوکت با دمای اتاق و D کرم مرطوب کننده و آنژیوکت با دمای معمولی. بلوک ها به صورت ABCD,BCDA,CDBA,CDAB,DACB..... خواهد بود. توالی بلوک ها به صورت تصادفی ساده خواهد بود.
    تصادفی‌سازی با استفاده از یک لیست تصادفی تولید شده توسط کامپیوتر با بلوک‌های جایگشتی با اندازه هشت، که توسط یک متخصص آمار مستقل تهیه شده بود، انجام شد. تخصیص با استفاده از ۸۸ پاکت مهر و موم شده، مات و با شماره‌های متوالی که در زمان تخصیص باز شده بودند، پنهان‌سازی شد.

  • Health conditions studied

    #1
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    empty
    Fear
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    ترس

  • Primary outcomes

    #1
    شدت درد
    درد
    #2
    empty
    Fear
    empty
    ترس
    empty
    Before and during the intervention
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    قبل از مداخله و در حین انجام مداخله
    empty
    Children's Fear Scale
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    مقیاس ترس کودکان

  • Recruitment centers

    #1
    Name of recruitment center - English: Sheikh Hospital of Mashhad
    Name of recruitment center - Persian: بیمارستان شیخ مشهد
    Full name of responsible person - English: fateme borzoee
    Full name of responsible person - Persian: فاطمه برزوئی
    Street address - English: Dr. Sheikh Hospital,Tohid Square, Motahari Avenue
    Street address - Persian: خیابان مطهری- میدان توحید- بیمارستان دکتر شیخ
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9617913114
    Phone: +98 51 4401 1000
    Fax:
    Email: borzoee75026@yahoo.com
    Web page address:
    Name of recruitment center - English: Sheikh Hospital of Mashhad
    Name of recruitment center - Persian: بیمارستان شیخ مشهد
    Full name of responsible person - English: fateme borzoee
    Full name of responsible person - Persian: فاطمه برزوئی
    Street address - English: Dr. Sheikh Hospital,Tohid Square, Motahari Avenue
    Street address - Persian: خیابان مطهری، میدان توحید، بیمارستان دکتر شیخ
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9617913114
    Phone: +98 51 4401 1000
    Fax:
    Email: borzoee75026@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fateme Borzoee
    Full name of responsible person - Persian: فاطمه برزوئی
    Street address - English: School of Nursing and Midwifery; Shohadaye Hasteii Boulevard, Sabzevar
    Street address - Persian: سبزوار - بلوار شهدای هسته ای- بالاتر از مزار شهدای گمنام -پردیس دانشگاه علوم پزشکی سبزوار
    City - English: sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9617913112
    Phone: +98 51 4401 1000
    Fax:
    Email: borzoee75026@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Javadinia
    Full name of responsible person - Persian: علیرضا جوادی نیا
    Street address - English: Shohadaye Hasteii Boulevard
    Street address - Persian: بلوار شهدای هسته ای
    City - English: sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9617913112
    Phone: +98 51 4401 1000
    Fax:
    Email: javadinia@gmail.com
    Web page address:

Protocol summary

Study aim
Comparison of the effectiveness of Xyla-p and cold needle cream on pain intensity during venipuncture in children under chemotherapy
Design
This double-blind, parallel-group randomized controlled trial included 87 children aged 2–6 years undergoing outpatient chemotherapy in Mashhad, Iran. Participants were randomized into four groups: control (routine care), cold angiocath, Xylap cream, and combination. Pain intensity and fear were assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) and Children’s Fear Scale (CFS), respectively, across four venipuncture sessions (one baseline, three intervention).
Settings and conduct
Sampling will be done in the chemotherapy ward of Sheikh Mashhad Hospital for children with leukemia aged 2-6 years. Children and statistical analysts do not know how to inject.
Participants/Inclusion and exclusion criteria
Inclusion criteria Age of 6 to 2 years, having complete consciousness, sedative medication and Receive chemotherapy every week At least one month has passed since the onset of the disease. the exclusion criteria to the study: Failure to insert the intravenous line with one time cannula insertion
Intervention groups
In the first week, as basic information is collected, the injection is performed routinely, without any cream or angiocatheter with a needle at room temperature. In the following weeks, injections will be performed 3 times in one of the 4 methods (The first group is xylophone and cold angiocatheter, the second group of angiocatheter with cold needle and moisturizing cream, the third group of xylophone cream and angiocatheter with room temperature, the fourth group of moisturizing cream and angiocatheter with needle at room temperature.). Therefore, intervention and data collection in each child is measured in 4 times.
Main outcome variables
Pain; Fear

General information

Reason for update
The fear variable was initially measured because it was considered a confounding variable to estimate the effect of this confounder on the study results. Then, it was decided that reporting this variable as a dependent variable could provide more information (the effect of independent variables on pain as well as fear) to the readers of the article.
Acronym
IRCT registration information
IRCT registration number: IRCT20131113015393N7
Registration date: 2021-11-06, 1400/08/15
Registration timing: prospective

Last update: 2025-10-21, 1404/07/29
Update count: 1
Registration date
2021-11-06, 1400/08/15
Registrant information
Name
Narjes Heshmati Far
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1444 6070
Email address
nheshmatifar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-27, 1400/08/05
Expected recruitment end date
2022-07-27, 1401/05/05
Actual recruitment start date
2021-11-13, 1400/08/22
Actual recruitment end date
2023-02-26, 1401/12/07
Trial completion date
2023-02-26, 1401/12/07
Scientific title
Comparison of the effectiveness of Xyla-p and cold needle cream on fear and pain during venipuncture in children under chemotherapy
Public title
Comparison of the effectiveness of Xyla-p and cold needle cream on fear and pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 18 to 65 years Have leukemia Outpatients refer to the chemotherapy department Receive chemotherapy every week At least one month has passed since the onset of the disease
Exclusion criteria:
Restless children The children with loss of consciousness Children receive sedative or analgesic Children with a history of sensitivity to lidocaine.
Age
From 2 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 87
Actual sample size reached: 87
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed using a computer-generated random list with permuted blocks of size eight, prepared by an independent statistician. Allocation was concealed using 88 sequentially numbered, opaque, sealed envelopes, opened at the time of assignment.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. The participant (child and parent) is not aware of the injection method. The statistical analyzer will not know the injection method and the data will be provided to him in the form of codes A, B, C and D.
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
Deputy of Research and Technology, Sabzevar University of Medical Sciences, SHohada Hastei Boulevard.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2021-06-13, 1400/03/23
Ethics committee reference number
IR.MEDSAB.REC.1400.041

Health conditions studied

1

Description of health condition studied
Acute pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

2

Description of health condition studied
Fear
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
Before and during the intervention
Method of measurement
Flacc Scale

2

Description
Fear
Timepoint
Before and during the intervention
Method of measurement
Children's Fear Scale

Secondary outcomes

empty

Intervention groups

1

Description
In the present research, we will have 2 methods (2 intervention) for injection. The first method, using cold angiocatheter: venipuncture is performed by cooled angiocatheter kept at -20 °C freezer for at least one hour in a steel box. After identifying the target vein, the angiocatheter is immediate will be removed from the freezer and the venipuncture will be performed. The second method, using Xyla-p cream: venipuncture is done by rubbing 2.5 grams of Xyla-p cream on the 20-25 cm2 and covering it with nylon dressing for at least 45 minutes. This intervention of study will be conducted in 4 groups of participants. The maximum dose of the cream for a child, weighing more than 10 kg is 100 g of cream per 100 cm2 of the skin for 4 hours according to the available guidelines. Due to the dose used in this study, there is no possibility of complications such as skin allergies. Intervention group: The intervention in group 1 is that Xyla-p cream (first intervention) and cold angiocatheter (second intervention) are used.
Category
Treatment - Devices

2

Description
Intervention group 2: The intervention is performed using Xyla-p cream (first intervention) and angiocatheter at room temperature (routine method).
Category
Treatment - Devices

3

Description
Intervention group 3: This includes performing the intervention using moisturizing cream (placebo) and cold angiocatheter (intervention).
Category
Treatment - Devices

4

Description
Control group: In this group, moisturizing cream (placebo) and angiocatheter are used at room temperature (routine method).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Sheikh Hospital of Mashhad
Full name of responsible person
fateme borzoee
Street address
Dr. Sheikh Hospital,Tohid Square, Motahari Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1000
Email
borzoee75026@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Alireza Javadinia
Street address
Shohadaye Hasteii Boulevard
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1000
Email
javadinia@gmail.com
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
Fateme Borzoee
Position
Faculty member of Sabzevar University
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Shohadaye Hasteii Boulevard, Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1000
Email
borzoee75026@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fateme Borzoee
Position
Faculty member of Sabzevar University
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Shohadaye Hasteii Boulevard, Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1000
Email
borzoee75026@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fateme Borzoee
Position
Faculty member of Sabzevar University
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Shohadaye Hasteii Boulevard, Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1000
Email
borzoee75026@yahoo.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
Not applicable
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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