The present study is a single blind randomized clinical trial study in which 6 to 15 year old children referred to outpatient chemotherapy ward of Dr. Sheikh Hospital who meet the inclusion criteria and meet the inclusion criteria. And after obtaining consent based on the permutation block they will be divided into two groups.
Settings and conduct
The present study is a single blind clinical trial study in which the study units were selected from 6-15 year old children referred to outpatient chemotherapy ward of Dr. Sheikh Hospital and met the inclusion criteria. Obtaining consent based on the permutation block will fall into two groups.
Participants/Inclusion and exclusion criteria
Informed consent to participate in the research
Children aged 6 to 15 years
Children with cancer with a history of venous puncture in the maintenance phase
The child should be fully alert.
The patient is inclined to use virtual glasses.
Use of distal organs vessels
Intervention groups
Intervention group of children aged 6-15 years referred to chemotherapy ward
Patients with a history of intravenous puncture in the maintenance phase who will receive virtual reality glasses in the intervention group to reduce anxiety during venipuncture.
People in the control group are the same as those in the intervention group, which will have a routine procedure of venipuncture.
Main outcome variables
Reduce Anxiety and Stress in Children during the Venous Disease; More Pediatric Co-operation and Adherence in the Disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190815044536N1
Registration date:2020-03-06, 1398/12/16
Registration timing:prospective
Last update:2020-03-06, 1398/12/16
Update count:0
Registration date
2020-03-06, 1398/12/16
Registrant information
Name
Mohammadreza Mosaddegh hesari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3760 6514
Email address
mosaddeghmr1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of virtual reality distraction on anxiety from intravenous catheter placement and adherence to treatment in children 6 to 15 years with cancer
Public title
The effect of virtual reality on catheter insertion anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the research ..
Children aged 6 to 15 years
Children with cancer with a history of venous puncture in the maintenance phase
The child should be fully alert
The patient is inclined to use virtual glasses
Use of distal organs vessels
Exclusion criteria:
"Use of proximal child vessels for angiectomy"
"Children over 15 years or under 6 years"
"Children with cancer before entering the maintenance phase of treatment"
Age
From 6 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Research units from the research community that meet the research criteria will first be selected as accessible and purpose-based, and then randomly assigned to a 4-block permutation method in two virtual reality and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Anxiety in children with cancer during the process of obtaining an angiocut
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score in the observation tool(OSBD-R )
Timepoint
Measuring and observing anxious behavior 5 minutes before and immediately after the intervention
Method of measurement
Anxiety Assessment Tool (OSBD-R) A researcher-made treatment adherence assessment tool
Secondary outcomes
1
Description
heart beat
Timepoint
Before the intervention, during the intervention, immediately after the intervention
Method of measurement
Pulse Oximeter Device
2
Description
Arterial Blood Oxygen Level
Timepoint
Before the intervention, during the intervention, immediately after the intervention
Method of measurement
Pulse Oximeter Device
Intervention groups
1
Description
Evaluation of venous placement and venous placement will be undertaken as the glasses are put on and the child calming clip begins to air. Anxiety levels will be measured and recorded by standard instruments before and immediately after the venous process is completed.To assess treatment adherence at the next follow-up (one month later) in the intervention and control group, the self-adherence questionnaire of treatment adherence will be completed by the researcher by interviewing parents or children.
Category
Behavior
2
Description
Anxiety tool will be completed before and after the vein is completed. To assess treatment adherence at the next follow-up (one month later) in the intervention and control group, the self-administered adherence questionnaire will be completed by the researcher by interviewing parents or children.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Sheikh Mashhad Pediatric Hospital
Full name of responsible person
Mohammad Reza Mosadegh Hesari
Street address
Dr. Sheikh Pediatric Hospital, Shahid Gharani 1, Shahid Gharani Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9188766956
Phone
+98 51 3726 9021
Email
MosaddeghMR1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences، Imam Khomeini street, Gonabad,
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3028
Fax
+98 51 8722 3814
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
20
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Reza Mossadegh Hesari
Position
Head of Chemistry Department of Sheikh Mashhad Pediatric Hospital
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Sheikh Pediatric Hospital، Martyr Gharani 6، Shahid Gharani Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9188766956
Phone
+98 51 3726 9021
Email
MosaddeghMR1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Mossadegh Hesari
Position
Head of Chemistry Department of Sheikh Mashhad Pediatric Hospital
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Sheikh Pediatric Hospital، Shahid Gharani 6، Shahid Gharani Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9188766956
Phone
+98 51 3604 6516
Email
MosaddeghMR1@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Mossadegh Hesari
Position
Head of Chemistry Nursing and Pediatric Hospital of Dr. Sheikh Mashhad
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Sheikh Pediatric Hospital،Shahid Gharani 6، Shahid Gharani Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9188766956
Phone
+98 51 3604 6516
Email
MosaddeghMR1@mums.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All potential data can be shared after unidentifiable people.
When the data will become available and for how long
Start of access period from 1399
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
To guide and design the type of study and way of working for researchers working in academic and scientific institutions
From where data/document is obtainable
1.Email address:MosaddeghMR1@mums.ac.ir
2.2. Contact with phone number:09151179193
What processes are involved for a request to access data/document
Request an Email Address and Submit a Request for Voice and No Replies Contact Cell Phone: 09151179193