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Protocol summary
The study will be done in the hemodialysis unit of Mashhad Hefdah Shahrivar Hospital. 15 hemodialysis patients whose vascular access is through arterial venous fistula are selected according to the inclusion criteria by simple random sampling method. Exact sample size estimate is done through pilot study.
The study will be done in the hemodialysis unit of Mashhad montaseriye and Hefdah Shahrivar Hospital. 30 hemodialysis patients whose vascular access is through arterial venous fistula are selected according to the inclusion criteria by simple random sampling method.
The study will be done in the hemodialysis unit of Mashhad montaseriye and Hefdah Shahrivar Hospital. 1530 hemodialysis patients whose vascular access is through arterial venous fistula are selected according to the inclusion criteria by simple random sampling method. Exact sample size estimate is done through pilot study.
در بخش همودیالیز بیمارستان 17 شهریور مشهد، تعداد 15 بیمار تحت همودیالیز که دسترسی عروقی آنها از طریق فیستول شریانی وریدی می باشد بر طبق معیارهای ورود به روش نمونه گیری غیر تصادفی ساده انتخاب می شوند. براورد حجم دقیق نمونه بصورت پایلوت انجام می پذیرد.
در بخش همودیالیز بیمارستان منتصریه و 17 شهریور مشهد، تعداد 30 بیمار تحت همودیالیز که دسترسی عروقی آنها از طریق فیستول شریانی وریدی می باشد بر طبق معیارهای ورود به روش نمونه گیری غیر تصادفی ساده انتخاب شدند.
در بخش همودیالیز بیمارستان منتصریه و 17 شهریور مشهد، تعداد 1530 بیمار تحت همودیالیز که دسترسی عروقی آنها از طریق فیستول شریانی وریدی می باشد بر طبق معیارهای ورود به روش نمونه گیری غیر تصادفی ساده انتخاب می شوندشدند. براورد حجم دقیق نمونه بصورت پایلوت انجام می پذیرد.
General information
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2018-06-05, 1397/03/15
2018-06-05 00:00:00
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2018-08-14, 1397/05/23
2018-08-14 00:00:00
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2018-08-14, 1397/05/23
2018-08-14 00:00:00
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Recruitment centers
#1
Name of recruitment center - English: 17 Shahrivar haspital
Name of recruitment center - Persian: بیمارستان 17 شهریور
Full name of responsible person - English: Malekzadeh Javad
Full name of responsible person - Persian: جواد ملک زاده
Street address - English: Koohsangi Street
Street address - Persian: خیابان کوهسنگی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 51 3343 2335
Fax:
Email: Malekzadehj@mums.ac.ir
Web page address:
Name of recruitment center - English: 17 Shahrivar haspital
Name of recruitment center - Persian: بیمارستان 17 شهریور
Full name of responsible person - English: Javad Malekzadeh
Full name of responsible person - Persian: جواد ملک زاده
Street address - English: Koohsangi Street
Street address - Persian: خیابان کوهسنگی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 51 3343 2335
Fax:
Email: Malekzadehj@mums.ac.ir
Web page address:
Name of recruitment center - English: 17 Shahrivar haspital Name of recruitment center - Persian: بیمارستان 17 شهریور Full name of responsible person - English: Javad Malekzadeh Javad Full name of responsible person - Persian: جواد ملک زاده Street address - English: Koohsangi Street Street address - Persian: خیابان کوهسنگی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 1111111111 Phone: +98 51 3343 2335 Fax: Email: Malekzadehj@mums.ac.ir Web page address:
#2
Name of recruitment center - English: montaserieh hospital
Name of recruitment center - Persian: بیمارستان منتصریه
Full name of responsible person - English: Javad Malekzadeh
Full name of responsible person - Persian: جواد ملک زاده
Street address - English: janat
Street address - Persian: جنت
City - English: mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 51 3343 2335
Fax:
Email: Malekzadehj@mums.ac.ir
Web page address:
Name of recruitment center - English: montaserieh hospital Name of recruitment center - Persian: بیمارستان منتصریه Full name of responsible person - English: Javad Malekzadeh Full name of responsible person - Persian: جواد ملک زاده Street address - English: janat Street address - Persian: جنت City - English: mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 1111111111 Phone: +98 51 3343 2335 Fax: Email: Malekzadehj@mums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Tafaghodi Mohsen
Full name of responsible person - Persian: محسن تفقدی
Street address - English: Quraishi Building, University Street
Street address - Persian: خیابان دانشگاه، ساختمان قریشی
City - English: Mashad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9919191778
Phone: +98 51 3841 3007
Fax:
Email: presidentoffice@mums.ac.ir
Web page address: http://v-research.mums.ac.ir/
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohsen Tafaghodi
Full name of responsible person - Persian: محسن تفقدی
Street address - English: Quraishi Building, Daneshgah Street
Street address - Persian: خیابان دانشگاه، ساختمان قریشی
City - English: Mashad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9919191778
Phone: +98 51 3841 3007
Fax:
Email: presidentoffice@mums.ac.ir
Web page address: http://v-research.mums.ac.ir/
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mohsen Tafaghodi Mohsen Full name of responsible person - Persian: محسن تفقدی Street address - English: Quraishi Building, UniversityDaneshgah Street Street address - Persian: خیابان دانشگاه، ساختمان قریشی City - English: Mashad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9919191778 Phone: +98 51 3841 3007 Fax: Email: presidentoffice@mums.ac.ir Web page address: http://v-research.mums.ac.ir/
Protocol summary
Study aim
Determination of the effect of reflection of mirrors (flat and convex) with and without adjustment phase on severity of pain due to needle insertion into the arterial fistula of the hemodialysis patients
Design
A Clinical trial with one group (before and after)
Settings and conduct
The study will be done in the hemodialysis unit of Mashhad montaseriye and Hefdah Shahrivar Hospital. 30 hemodialysis patients whose vascular access is through arterial venous fistula are selected according to the inclusion criteria by simple random sampling method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hemodialysis sessions three times a week; vascular access of arterial venous fistula; to be under hemodialysis through the current fistula for at least6 months; age range of 18-70; awareness of time, place and person; ability to speak and understand Persian
Exclusion criteria: fever of more than 37.5 degrees; oral or local intake of painkiller or sedation less than 6 hours before hemodialysis; use of psychoactive drugs 24 hours before hemodialysis; skin disorders at the injection site (ulcer, sensitivity, redness, secretion); problems with vision and myopia disturbances (30 cm or less)
Intervention groups
Each patient will be studied during 5 sessions. In the first session, as the control session, there is no intervention. During the next four sessions, one of two types of mirrors (flat and convex) will be used. Each mirror is used in 2 sessions.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180412039277N1
Registration date:2018-06-07, 1397/03/17
Registration timing:registered_while_recruiting
Last update:2018-12-31, 1397/10/10
Update count:1
Registration date
2018-06-07, 1397/03/17
Registrant information
Name
Zahra Rajabzadeh Malayjerdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3623 7295
Email address
rajabzadehmz1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-28, 1397/02/08
Expected recruitment end date
2018-06-19, 1397/03/29
Actual recruitment start date
2018-06-05, 1397/03/15
Actual recruitment end date
2018-08-14, 1397/05/23
Trial completion date
2018-08-14, 1397/05/23
Scientific title
The Effect of Various Mirror Reflection Visual Illusion on Pain Intensity due to Needle Insertion in Arterio-Venous Fistula Hemodialysis Patient's
Public title
The Effect of Mirror Reflection Visual Illusion on Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed Consent to Participate in all Study Sessions
Hemodialysis Sessions should be three times a Week
Vascular Access to the Arterial Venous Fistula
Passing at least 6 Months from Hemodialysis via current Fistula
Being able to Speak and Understand Persian
Orientation to time, place and person
Exclusion criteria:
Visual Impairment and Disturbed Close Vision (30 cm or less)
Skin Disorders at the Injection Site (Wound, Sensitivity, Redness, Secretion)
using oral, topical or sedative drugs during 6 hours before Hemodialysis
using Psychoactive Drugs 24 hours before Hemodialysis
Fever Greater than 37.5 Celsius Degrees
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Actual sample size reached:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Quraishi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-04-07, 1397/01/18
Ethics committee reference number
IR.MUMS.REC.1397,9
Health conditions studied
1
Description of health condition studied
The pain caused by the insertion of fistula needles in hemodialysis patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity
Timepoint
During the 5 sessions of hemodialysis (control and intervention sessions) immediately after the needle is inserted into the fistula
Method of measurement
Pain Visual Analogue Scale
Secondary outcomes
1
Description
The amount of visual illusion
Timepoint
During the 4 sessions of hemodialysis (intervention sessions), immediately after the needle is inserted into the fistula
Method of measurement
Longo Questionnaire
Intervention groups
1
Description
Control session (first sampling session): Needle entry to the fistula is performed by the nurse of the hemodialysis unit without any intervention. Intervention sessions (second and third sampling sessions): The hospital bed's nightstand will be placed in front of the patient. We ask the patient to put his both hands on the table. The mirror of that session, which has been randomly selected for that session in advance, will be placed between the patient's hands at a distance of 30 cm from the forefinger of each hand, so that the healthy hand will be in front of the mirror and the hand with the fistula will be behind the mirror. We ask the patient to look at the picture of his healthy hand in the mirror. Immediately, the needle is inserted into the fistula of the hand behind the mirror by the nurse of the hemodialysis unit. Intervention sessions (fourth and fifth sampling sessions): The hospital bed's nightstand will be placed in front of the patient. We ask the patient to put both hands on the table. The mirror of that session, which has been randomly selected for that session in advance, is placed between the patient's hands at a distance of 30 cm from the forefinger of each hand, so that the healthy hand is in front of the mirror and the hand with the fistula is behind the mirror. We ask the patient to look at the picture of his healthy hand in the mirror for ten minutes. After ten minutes, the needle is inserted into the fistula of the hand behind the mirror by the nurse of the hemodialysis unit.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar haspital
Full name of responsible person
Javad Malekzadeh
Street address
Koohsangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
1111111111
Phone
+98 51 3343 2335
Email
Malekzadehj@mums.ac.ir
2
Recruitment center
Name of recruitment center
montaserieh hospital
Full name of responsible person
Javad Malekzadeh
Street address
janat
City
mashhad
Province
Razavi Khorasan
Postal code
1111111111
Phone
+98 51 3343 2335
Email
Malekzadehj@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Quraishi Building, Daneshgah Street
City
Mashad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3841 3007
Email
presidentoffice@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Rajabzadeh Malayjerdi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ebne Sina Street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
rajabzadehmz1@mums.ac.ir
Web page address
http://nurse.mums.ac.ir/index.php
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Rajabzadeh Malayjerdi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ebne Sina Street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
rajabzadehmz1@mums.ac.ir
Web page address
http://nurse.mums.ac.ir/index.php
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Rajabzadeh Malayjerdi
Position
masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
rajabzadehmz1@mums.ac.ir
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