Comparison the effect of Distraction on two methods of virtual reality and guided visualization on pain caused by venous cannulation in hemodialysis patients
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General information
1
1
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Due to intervention and outcome evaluation, the researcher, investigator and analyst assistant does not know the type of intervention performed during the sessions.
Due to intervention and outcome evaluation, the researcher, investigator and analyst assistant does not know the type of intervention performed during the sessions.
empty
بدلیل انجام مداخله و ارزیابی پیامد توسط دستیار پژوهشگر، محقق و انالیزکننده داده ها از نوع مداخله انجام شده در جلسات مطلع نیستند.
بدلیل انجام مداخله و ارزیابی پیامد توسط دستیار پژوهشگر، محقق و انالیزکننده داده ها از نوع مداخله انجام شده در جلسات مطلع نیستند.
Due to the registration of pain score, the assistant researcher will blind blind
Due to the registration of pain score, the assistant researcher will blind blind
بدلیل ثبت نمره درد توسط دستیار پژوهشگر، پژوهشگر کور خواهد شد.
بدلیل ثبت نمره درد توسط دستیار پژوهشگر، پژوهشگر کور خواهد شد.
Intervention groups
#1
Intervention group number 1: After receiving informed consent from the patient, the demographic questionnaire is filled in half an hour before the intervention. Then, 25 minutes before hemodialysis, the patients are in supine position, then a few deep abdominal cavities and a diaphragm with closed eyes and comfortable in the best condition in which it relaxes. By providing a quiet, quiet environment and by minimizing environmental stimuli (such as low-light room, walking limits) into an audio file and focusing on the visualization of an illustration, a desirable scenario of listening to the stage-by-stage relaxation of the limbs will be listened without any muscle movement. Audio file The content of mental imagery is played back for 20 minutes, taking into account the sound level between 21 and 10 dB (calibrated by the audiometric expert) so that the person who narrates the text's speaker in the visualization state of the image is in the desired desirable landscape. Then the data will be collected by the researcher when the file passes for 15 minutes (5 minutes to complete the audio)
Intervention group number 1: After receiving informed consent from the patient, the demographic questionnaire is filled in half an hour before the intervention. Then, 25 minutes before hemodialysis, the patients are in supine position, then a few deep abdominal cavities and a diaphragm with closed eyes and comfortable in the best condition in which it relaxes. By providing a quiet, quiet environment and by minimizing environmental stimuli (such as low-light room, walking limits) into an audio file and focusing on the visualization of an illustration, a desirable scenario of listening to the stage-by-stage relaxation of the limbs will be listened without any muscle movement. Audio file The content of mental imagery is played back for 20 minutes, taking into account the sound level between 21 and 10 dB (calibrated by the audiometric expert) so that the person who narrates the text's speaker in the visualization state of the image is in the desired desirable landscape. Then the data will be collected by the researcher's assistant when the file passes for 15 minutes (5 minutes to complete the audio). During cannulation, the patient determines the intensity of his pain by marking a 10-cm line. The assistant researcher measures and records the distance between the zero point and the location of the sign.
Intervention group number 1: After receiving informed consent from the patient, the demographic questionnaire is filled in half an hour before the intervention. Then, 25 minutes before hemodialysis, the patients are in supine position, then a few deep abdominal cavities and a diaphragm with closed eyes and comfortable in the best condition in which it relaxes. By providing a quiet, quiet environment and by minimizing environmental stimuli (such as low-light room, walking limits) into an audio file and focusing on the visualization of an illustration, a desirable scenario of listening to the stage-by-stage relaxation of the limbs will be listened without any muscle movement. Audio file The content of mental imagery is played back for 20 minutes, taking into account the sound level between 21 and 10 dB (calibrated by the audiometric expert) so that the person who narrates the text's speaker in the visualization state of the image is in the desired desirable landscape. Then the data will be collected by the researcherresearcher's assistant when the file passes for 15 minutes (5 minutes to complete the audio). During cannulation, the patient determines the intensity of his pain by marking a 10-cm line. The assistant researcher measures and records the distance between the zero point and the location of the sign.
گروه مداخله 1: پس از اخذ رضایت آگاهانه از بیمار ابتدا نیم ساعت قبل از مداخله پرسشنامه اطلاعات دموگرافیک پر میشود. سپس 25دقیقه قبل از زمان همودیالیز، بیماران در حالت طاقباز، پس چند نفس عمیق شکمی و دیافراگمی با چشمان بسته و راحت در بهترین وضعیتی که در آن احساس آرامش میکند قرار میگیرد. با فراهم ساختن محیطی کاملاً آرام، ساکت و با به حداقل رساندن تحریکات محیطی (مثل نور کم اتاق، محدودیت رفتوآمد) به فایل صوتی و با تمرکز بر تجسم تصویرسازی یک منظره مطلوب دلخواه آرامیدگی مرحله به مرحله اندامها بدون وجود حرکت عضلانی گوش فرا خواهند داد. سیدی فایل صوتی مطالب اجرای تصویرسازی ذهنی به مدت 20 دقیقه با در نظر گرفتن میزان صدای بین 21 تا 10 دسیبل (کالیبره کردن توسط متخصص شنوایی سنجی) پخش میشود تا فرد باراهنمایی گوینده متن در وضعیت تجسم تصویرسازی یک منظره مطلوب دلخواه قرار میگیرد. سپس هنگامیکه 15 دقیقه از زمان پخش فایل بگذرد (5 دقیقه به اتمام صوت) جمع آوری دادهها توسط پژوهشگر انجام خواهد گرفت
گروه مداخله 1: پس از اخذ رضایت آگاهانه از بیمار ابتدا نیم ساعت قبل از مداخله پرسشنامه اطلاعات دموگرافیک پر میشود. سپس 25دقیقه قبل از زمان همودیالیز، بیماران در حالت طاقباز، پس چند نفس عمیق شکمی و دیافراگمی با چشمان بسته و راحت در بهترین وضعیتی که در آن احساس آرامش میکند قرار میگیرد. با فراهم ساختن محیطی کاملاً آرام، ساکت و با به حداقل رساندن تحریکات محیطی (مثل نور کم اتاق، محدودیت رفتوآمد) به فایل صوتی و با تمرکز بر تجسم تصویرسازی یک منظره مطلوب دلخواه آرامیدگی مرحله به مرحله اندامها بدون وجود حرکت عضلانی گوش فرا خواهند داد. سیدی فایل صوتی مطالب اجرای تصویرسازی ذهنی به مدت 20 دقیقه با در نظر گرفتن میزان صدای بین 21 تا 10 دسیبل (کالیبره کردن توسط متخصص شنوایی سنجی) پخش میشود تا فرد باراهنمایی گوینده متن در وضعیت تجسم تصویرسازی یک منظره مطلوب دلخواه قرار میگیرد. سپس هنگامیکه 15 دقیقه از زمان پخش فایل بگذرد (5 دقیقه به اتمام صوت) جمع آوری دادهها توسط دستیار پژوهشگر انجام خواهد گرفت. در هنگام رگ گیری، بیمار شدت درد خود را با علامت گذاری برروی یک خط 10 سانتیمتری تعیین میکند. دستیار پژوهشگر فاصله بین نقطه صفر تا محل علامت را اندازه گیری و ثبت میکند.
گروه مداخله 1: پس از اخذ رضایت آگاهانه از بیمار ابتدا نیم ساعت قبل از مداخله پرسشنامه اطلاعات دموگرافیک پر میشود. سپس 25دقیقه قبل از زمان همودیالیز، بیماران در حالت طاقباز، پس چند نفس عمیق شکمی و دیافراگمی با چشمان بسته و راحت در بهترین وضعیتی که در آن احساس آرامش میکند قرار میگیرد. با فراهم ساختن محیطی کاملاً آرام، ساکت و با به حداقل رساندن تحریکات محیطی (مثل نور کم اتاق، محدودیت رفتوآمد) به فایل صوتی و با تمرکز بر تجسم تصویرسازی یک منظره مطلوب دلخواه آرامیدگی مرحله به مرحله اندامها بدون وجود حرکت عضلانی گوش فرا خواهند داد. سیدی فایل صوتی مطالب اجرای تصویرسازی ذهنی به مدت 20 دقیقه با در نظر گرفتن میزان صدای بین 21 تا 10 دسیبل (کالیبره کردن توسط متخصص شنوایی سنجی) پخش میشود تا فرد باراهنمایی گوینده متن در وضعیت تجسم تصویرسازی یک منظره مطلوب دلخواه قرار میگیرد. سپس هنگامیکه 15 دقیقه از زمان پخش فایل بگذرد (5 دقیقه به اتمام صوت) جمع آوری دادهها توسط دستیار پژوهشگر انجام خواهد گرفت. در هنگام رگ گیری، بیمار شدت درد خود را با علامت گذاری برروی یک خط 10 سانتیمتری تعیین میکند. دستیار پژوهشگر فاصله بین نقطه صفر تا محل علامت را اندازه گیری و ثبت میکند.
#2
Intervention group number 2: In the virtual reality group, 10 minutes before the dialysis, special glasses are placed on the head of the patient and they spend 20 minutes spelling pictures designed to reduce pain. After 15 minutes of playing the file, during the watch, the fistula placement and the pain score will be measured by the researcher.
Intervention group number 2: In the virtual reality group, 10 minutes before the dialysis, special glasses are placed on the head of the patient and they spend 20 minutes spelling pictures designed to reduce pain. After 15 minutes of playing the file, during the watch, the fistula placement and the pain score will be measured by the researcher's assistant. During cannulation, the patient determines the intensity of his pain by marking a 10-cm line. The assistant researcher measures and records the distance between the zero point and the location of the sign.
Intervention group number 2: In the virtual reality group, 10 minutes before the dialysis, special glasses are placed on the head of the patient and they spend 20 minutes spelling pictures designed to reduce pain. After 15 minutes of playing the file, during the watch, the fistula placement and the pain score will be measured by the researcher's assistant. During cannulation, the patient determines the intensity of his pain by marking a 10-cm line. The assistant researcher measures and records the distance between the zero point and the location of the sign.
گروه مداخله 2: در گروه واقعیت مجازی،10 دقیقه قبل از دیالیز عینک های مخصوص برروی سر بیمار گذاشته میشود و بمدت 20 دقیقه به پخش تصاویری که برای کاهش درد طراحی شده اند میپردازد. بعد از گذشت 15 دقیقه از پخش فایل و در حین تماشا عمل جایگذاری فیستول و اندازه گیری نمره درد توسط پژوهشگر انجام خواهد شد.
گروه مداخله 2: در گروه واقعیت مجازی،10 دقیقه قبل از دیالیز عینک های مخصوص برروی سر بیمار گذاشته میشود و بمدت 20 دقیقه به پخش تصاویری که برای کاهش درد طراحی شده اند میپردازد. بعد از گذشت 15 دقیقه از پخش فایل و در حین تماشا عمل جایگذاری فیستول و اندازه گیری نمره درد توسط دستیار پژوهشگر انجام خواهد شد. در هنگام رگ گیری، بیمار شدت درد خود را با علامت گذاری برروی یک خط 10 سانتیمتری تعیین میکند. دستیار پژوهشگر فاصله بین نقطه صفر تا محل علامت را اندازه گیری و ثبت میکند.
گروه مداخله 2: در گروه واقعیت مجازی،10 دقیقه قبل از دیالیز عینک های مخصوص برروی سر بیمار گذاشته میشود و بمدت 20 دقیقه به پخش تصاویری که برای کاهش درد طراحی شده اند میپردازد. بعد از گذشت 15 دقیقه از پخش فایل و در حین تماشا عمل جایگذاری فیستول و اندازه گیری نمره درد توسط دستیار پژوهشگر انجام خواهد شد. در هنگام رگ گیری، بیمار شدت درد خود را با علامت گذاری برروی یک خط 10 سانتیمتری تعیین میکند. دستیار پژوهشگر فاصله بین نقطه صفر تا محل علامت را اندازه گیری و ثبت میکند.
Protocol summary
Study aim
Determining the Effect of Virtual Reality and Guided Imaging Technique on the Pain Caused by the Injection of Catheter in Hemodialysis Patients
Design
The clinical trial includes a group that initially receives intervention 1 (guided visualization technique) and then intervention 2 (virtual reality). The sample size is 60 people without randomization. The trial phase does not apply to this study.
Settings and conduct
This study will be carried out at Bhlul Hospital in Gonabad. The diversion of thought is guided by the technique of visualization and virtual reality technology, and its effect on the pain caused by cannulation will be measured.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age of 18-60; Awareness of time, place and persons at the time of data collection; Minimal reading and writing skills
No entry Criteria: Lack of Diabetic neuropathy; history of mental illness; continues use of analgesics 24 hours before hemodialysis; damaged skin in the intended position; ; use of alcohol and drugs
Intervention groups
Intervention 1: Distraction with the guided visualization technique in two intermittent dialysis sessions
Intervention 2: Deviation of thought with virtual reality technology in two intermittent dialysis sessions
Main outcome variables
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171219037966N3
Registration date:2018-06-13, 1397/03/23
Registration timing:retrospective
Last update:2018-08-24, 1397/06/02
Update count:2
Registration date
2018-06-13, 1397/03/23
Registrant information
Name
Amirreza Nasirzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
nasirzadeh@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-13, 1396/12/22
Expected recruitment end date
2018-06-10, 1397/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Distraction on two methods of virtual reality and guided visualization on pain caused by venous cannulation in hemodialysis patients
Public title
Comparison of the effect of two virtual reality methods and guided visualization on intravenous cannulation pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 60 years
Awareness of time, place and persons at the time of data collection
Minimal the reading and writing skills
Exclusion criteria:
history of mental illness
diabetic neuropathy
patient unwillingness to continue the study
continues use of analgesics 24 hours before hemodialysis
usevof alcohol and drugs
damaged skin in the intended position
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Due to intervention and outcome evaluation, the researcher, investigator and analyst assistant does not know the type of intervention performed during the sessions.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Asian Roadside Border
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.GMU.REC.1396.163
Health conditions studied
1
Description of health condition studied
chronic renal failure
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
pain
Timepoint
The beginning of the study; the first intervention session and 2, 9 and 11 days after the first intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group number 1: After receiving informed consent from the patient, the demographic questionnaire is filled in half an hour before the intervention. Then, 25 minutes before hemodialysis, the patients are in supine position, then a few deep abdominal cavities and a diaphragm with closed eyes and comfortable in the best condition in which it relaxes. By providing a quiet, quiet environment and by minimizing environmental stimuli (such as low-light room, walking limits) into an audio file and focusing on the visualization of an illustration, a desirable scenario of listening to the stage-by-stage relaxation of the limbs will be listened without any muscle movement. Audio file The content of mental imagery is played back for 20 minutes, taking into account the sound level between 21 and 10 dB (calibrated by the audiometric expert) so that the person who narrates the text's speaker in the visualization state of the image is in the desired desirable landscape. Then the data will be collected by the researcher's assistant when the file passes for 15 minutes (5 minutes to complete the audio). During cannulation, the patient determines the intensity of his pain by marking a 10-cm line. The assistant researcher measures and records the distance between the zero point and the location of the sign.
Category
Other
2
Description
Intervention group number 2: In the virtual reality group, 10 minutes before the dialysis, special glasses are placed on the head of the patient and they spend 20 minutes spelling pictures designed to reduce pain. After 15 minutes of playing the file, during the watch, the fistula placement and the pain score will be measured by the researcher's assistant. During cannulation, the patient determines the intensity of his pain by marking a 10-cm line. The assistant researcher measures and records the distance between the zero point and the location of the sign.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bohloul Hospital
Full name of responsible person
Amir Rafie
Street address
Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
nasirzadeharnz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Sajjadi
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
moallef@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
30
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
Gonabad University of Medical Sciences
Full name of responsible person
Amirreza Nasirzadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
Email
nasirzadeh@gmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Seyyed Farzin Mircheraghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
Mircheraghi.sf@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Habib Shareinia
Position
MSc
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
shareinia.msn@gmail.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