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General information
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30
30
empty
2022-03-01, 1400/12/10
2022-03-01 00:00:00
empty
2022-08-10, 1401/05/19
2022-08-10 00:00:00
empty
2022-08-12, 1401/05/21
2022-08-12 00:00:00
empty
Termination of trial
Termination of trial
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خاتمه کارآزمایی
خاتمه کارآزمایی
Recruitment centers
#1
Name of recruitment center - English: Nohome day Hospital, Torbat Heydarieh University of Medical Sciences
Name of recruitment center - Persian: بیمارستان نهم دی دانشگاه علوم پزشکی تربت حیدریه
Full name of responsible person - English: mohammad namazi nia
Full name of responsible person - Persian: محمد نمازی نیا
Street address - English: Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
Street address - Persian: خیابان فردوسی شمالی, خیابان رازی, ساختمان دانشگاه علوم پزشکی تربت حیدریه
City - English: Torbat Heydariyeh
City - Persian: تربت حیدریه
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 95195481$6
Phone: +98 51 5222 6014
Fax:
Email: mnamazi99@gmail.com
Web page address:
Name of recruitment center - English: Nohome day Hospital, Torbat Heydarieh University of Medical Sciences
Name of recruitment center - Persian: بیمارستان نهم دی دانشگاه علوم پزشکی تربت حیدریه
Full name of responsible person - English: Mohammad Namazinia
Full name of responsible person - Persian: محمد نمازی نیا
Street address - English: Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
Street address - Persian: خیابان فردوسی شمالی, خیابان رازی, ساختمان دانشگاه علوم پزشکی تربت حیدریه
City - English: Torbat Heydariyeh
City - Persian: تربت حیدریه
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 95195481$6
Phone: +98 51 5222 6014
Fax:
Email: mnamazi99@gmail.com
Web page address:
Name of recruitment center - English: Nohome day Hospital, Torbat Heydarieh University of Medical Sciences Name of recruitment center - Persian: بیمارستان نهم دی دانشگاه علوم پزشکی تربت حیدریه Full name of responsible person - English: mohammad namazi niaMohammad Namazinia Full name of responsible person - Persian: محمد نمازی نیا Street address - English: Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St. Street address - Persian: خیابان فردوسی شمالی, خیابان رازی, ساختمان دانشگاه علوم پزشکی تربت حیدریه City - English: Torbat Heydariyeh City - Persian: تربت حیدریه Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 95195481$6 Phone: +98 51 5222 6014 Fax: Email: mnamazi99@gmail.com Web page address:
Protocol summary
Study aim
The effect of virtual reality on pain caused by needle insertion into venous arterial fistula in hemodialysis patients
Design
Clinical trial with control group, with parallel groups,Two blind, randomized, with a sample size of 30
Settings and conduct
In the intervention group, after selecting the desired video, the smartphone is placed inside the headset and the selected video is played through the virtual reality application.
Participants/Inclusion and exclusion criteria
Inclusion criteria: with chronic renal failure. Conditions of non-entry: do not want to continue participating in the research.
Intervention groups
In the intervention group, the patient is first explained how to perform the intervention. After selecting the desired video, the smartphone is placed inside the headset and the selected video is played through the virtual reality application. In the control group, without the patient realizing that routine care was performed and no other intervention was performed, the pain intensity and quality of pain will be measured at the same time intervals as the intervention group using the mentioned scales.
Main outcome variables
pain
General information
Reason for update
Termination of trial
Acronym
IRCT registration information
IRCT registration number:IRCT20180429039463N3
Registration date:2022-03-28, 1401/01/08
Registration timing:registered_while_recruiting
Last update:2023-01-03, 1401/10/13
Update count:1
Registration date
2022-03-28, 1401/01/08
Registrant information
Name
mohammad namazinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5222 5280
Email address
namazinm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
2022-03-01, 1400/12/10
Actual recruitment end date
2022-08-10, 1401/05/19
Trial completion date
2022-08-12, 1401/05/21
Scientific title
The effect of virtual reality on pain caused by needle insertion into venous arterial fistula in hemodialysis patients
Public title
The effect of virtual reality on pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have informed consent to participate in all study sessions.
Hemodialysis sessions should be three times a week.
Have vascular access to venous arterial fistulas.
The minimum time for hemodialysis through a fistula is 6 months.
Be 18-70 years old.
Be aware of time, place and person.
Fluency in verbal communication in Persian.
Absence of underlying disease (neuropathy, Guillain-Barre, MS, etc.) that affects pain and pain perception.
No fever more than 37.5 degrees oral
Do not take oral or topical analgesics or sedatives less than 6 hours before hemodialysis
Do not take psychotropic drugs in the 24 hours before hemodialysis
Absence of skin disorders at the injection site
Absence of vision problems and impaired myopia (30 cm or less)
Exclusion criteria:
Reluctance to continue cooperation
Take painkillers or sedatives in more than two consecutive sessions
Taking psychotropic drugs in the previous 24 hours
Try to get a vein or needle more than twice in each vascular pathway
Fistula failure
Absence of the patient in two or more consecutive sessions
Existence of hearing problems
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Dividing people into two groups randomly will be used by the random permutation block method. In this way, using blocks with two treatments and a table of random numbers, individuals were assigned to two groups of control and intervention. Then, the personal information questionnaire in both intervention and control groups is completed through interviews. This questionnaire includes information about personal characteristics and medical records (age, sex, type of disease, etc.).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants and outcome assessors did not know whether participants were in the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Torbat Heydariyeh University of Medical Sciences
Street address
Torbat Heydariyeh University of Medical Sciences, Razi St., Torbat Heydariyeh, Iran
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9519633787
Approval date
2021-12-27, 1400/10/06
Ethics committee reference number
IR.THUMS.REC.1400.041
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N18
ICD-10 code description
chronic renal failure
Primary outcomes
1
Description
pain
Timepoint
Pain intensity is measured and recorded immediately, 15 minutes after the needle is inserted into the fistula, and pain quality is recorded and recorded 15 minutes after the needle is inserted into the fistula.
Method of measurement
Pain intensity scale (VAS) and pain quality will be measured and recorded with a short, modified form of the McGill Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the pain measurement will be measured with virtual reality in such a way that the pain measurement questionnaire is filled by the patient and then the distraction technique will be used once by the Shineken 4 virtual reality headset. First, the patient will be explained about the intervention method, then a list of 5 360-degree videos with nature content and at least 5 minutes will be provided to the patient to be selected to play a video. After selecting the desired video, the smartphone is placed inside the headset and the selected video is played through the virtual reality application. Prior to headset placement, VAS pain intensity and pain quality will be measured and recorded in a short, modified form of the McGill Questionnaire. From 5 minutes before the needle enters the venous arterial fistula, the headset is placed for the patient and the video will be played. At the end of the fifth minute, the nurse inserted the needle into the venous arterial fistula according to the standard method, and after the needle was fixed to the fistula, the video player stopped and the glasses were removed from the patient's eye. The severity of pain is measured and recorded immediately and 15 minutes after insertion of the needle into the fistula and the quality of pain 15 minutes after insertion of the needle into the fistula.
Category
N/A
2
Description
Control group: In the control group, without the patient realizing that routine care was performed and no other intervention was performed, the pain intensity and quality of pain will be measured at the same time intervals as the intervention group using the mentioned scales.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Nohome day Hospital, Torbat Heydarieh University of Medical Sciences
Full name of responsible person
Mohammad Namazinia
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95195481$6
Phone
+98 51 5222 6014
Email
mnamazi99@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rezaei Manesh
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95196-33787
Phone
+98 51 5222 8023
Email
mnamazi99@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Torbate-Heidaria 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
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Mohammad Namazinia
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95169-33787
Phone
+98 51 5222 6013
Email
mnamazi99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Mohammad Namazinia
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95169-33787
Phone
+98 51 5222 6013
Email
mnamazi99@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Mohammad Namazinia
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95169-33787
Phone
+98 51 5222 6013
Email
mnamazi99@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main consequence after being unidentified will be shared
When the data will become available and for how long
Start the access period 6 months after Publish results
To whom data/document is available
Everyone
Under which criteria data/document could be used
The results obtained in this study can be used without restriction by researchers.
From where data/document is obtainable
Referring to Torbat Heidarieh Nursing and Midwifery Faculty
What processes are involved for a request to access data/document
After sending the email to the person responsible for the response process begins.