Comparison of the Effect of Two Methods of Distraction and Acupressure on Pain and Anxiety of Peripheral Intravenous Cannulation in School-age Pediatric Cancer
Comparison of the effect of two methods of distraction and acupressure on pain and anxiety due to intravenous line insertion in school-age children with cancer.
Design
Cross-over clinical trial with control group،
Randomized with Randlist software، single blind ,
With 30 samples
Settings and conduct
Oncology ward of Tabriz and Urmia Children Hospitals
Entry of samples according to the inclusion criteria
Obtaining written consent
Intravenous surgery will be performed by a nurse according to the place of intervention in a fixed room.
The grade of pain and anxiety of the child before and after each child will be determined by the child and will be recorded by the researcher .
One-sided blind: The statistician will not know the study groups and what the patient has done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Children 6 to 12 years old admitted to oncology ward 2) Full vigilance to place, time and person 3) Ability to communicate verbally 4) Having previous experience of venipuncture 5) Obtain informed consent from the child and parents 6) Health of sight and hearing .Exclusion criteria: 1) Use pain-relieving medication within 8 hours before venereal 2) Enter the catheter more than once into the skin 3) The location of Hugo's point has previous injury and scarring and pain.
Intervention groups
Group A (cartoon): Cartoon playback with VR camera
Group B (Acupuncture): Hugo massage (five minutes before the start of the vein until the end of the intravenous massage line insertion for 1 minute massage and 10 seconds rest).
In group C (control), children are routinely given venipuncture.
Main outcome variables
Pain and anxiety score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100823004617N14
Registration date:2019-10-18, 1398/07/26
Registration timing:retrospective
Last update:2019-10-18, 1398/07/26
Update count:0
Registration date
2019-10-18, 1398/07/26
Registrant information
Name
Mahnaz Jabraeili
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
jabraeilim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-30, 1398/02/10
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Two Methods of Distraction and Acupressure on Pain and Anxiety of Peripheral Intravenous Cannulation in School-age Pediatric Cancer
Public title
"The Effect of Two Methods of Distraction and Acupressure on Pain and Anxiety"
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 12-6 admitted in the oncology department
Full conscious to place, time and person
The ability to communicate verbally
Having a previous experience of peripheral intravenous cannulation
Acquiring informed consent of the child and parents
The health of the eyes and the hearing
Exclusion criteria:
Use of pain relief medications 8 hours prior to peripheral intravenous cannulation
More than one catheter entry into the skin
The location of the Hugo Point has a previous injury and pain.
Perform a painful procedure on the baby within 8 hours of the baby's stroke
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
This is an experimental study that is a cross-over clinical trial, in which all the specimens are randomly assigned three times under the intravenous insertion procedure with randomized, routine, deviation, and acupressure. Among these three methods, the washout period is considered to be 24 to 72 hours. To conceal allocation, the child is asked to choose one of the opaque envelopes. Each envelope contains a triple block (watch a cartoon movie = A and a Hugo point massage = B) and a control (C) that shows the order of the intervention on the child. These envelopes are already being prepared by a research collaborator using the Randlist software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer does not know how to assign the samples to the study groups.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics committee
Street address
Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Approval date
2019-05-06, 1398/02/16
Ethics committee reference number
IR.TBZMED.REC.1398.115
Health conditions studied
1
Description of health condition studied
.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain caused by peripheral intravenous cannulation
Timepoint
Before the intervention and after the intervention
Method of measurement
VAS tool
2
Description
Anxiety caused by peripheral intravenous cannulation
Timepoint
Before the intervention and after the intervention
Method of measurement
FAS tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the intervention method a minute before the onset of intravenous line insertion , the child pain score was determined using the vas scale and the child anxiety score using the fas scale . the child will then be directed to an intravenous line . the sponge bob sponge is placed on the throne of the patient from the time the child is placed on the couch through the virtual space cameras that is placed on the retina of the patient and has the ability to transmit sound and the image . one minute after finishing the insertion , the child 's pain score and anxiety score will be recorded .
Category
Other
2
Description
Intervention group: in method of B , acupressure was determined before informing the child , child pain score using vas scale and child anxiety score using the fas scale . then the child is directed to the insertion of the intravenous line and the child is placed on the vein and then hugo 's point is determined . to determine the point of hugo in the intervention group , the finger of the child 's thumb is referred to the finger and in this case the peak muscle is produced . about five minutes before the procedure and by placing the child on the bed , the point will be massage in a rotating and relaxed position while the child is placed on the sofa by the researcher , so that the maximum pressure time per time is 1 minute and then the massage is discontinued for one minute . the procedure will continue until the procedure is completed . it should be noted that the insertion of the intravenous line in the hands of hugo is performed . one minute after finishing the insertion , the child 's pain score and anxiety score will be recorded .
Category
Other
3
Description
Control group: In the routine procedure, intravenous infusion will be performed as per routine procedure and the child will receive no additional intervention before or during intravenous infusion. Before announcing the baby's intravenous replacement, the child's pain and anxiety score will be determined using one of two scales. The child will then be directed to the IV line room and placed on the IV line bed. Then the child's vein embedding is performed by the researcher. The child's pain and anxiety scores will be recorded again one minute after the intravenous embolization is completed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
children 's hospital in Tabriz University of Medical Sciences
Full name of responsible person
mohammed saeidi
Street address
Sheshgelan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Email
kodakanhospital@tbzmed.ac.ir
2
Recruitment center
Name of recruitment center
Motahari Hospital of Urmia
Full name of responsible person
mohammed saeidi
Street address
Ayatollah Kashani st
City
urmia
Province
West Azarbaijan
Postal code
---
Phone
+98 44 3223 7077
Fax
Email
motaharihospital@umsu.ac.ir
Web page address
https://motahari.umsu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Rashidi
Street address
Researchِ Department - Central Building- Golgasht-Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
----------
Phone
+98 41 3335 5921
Email
info@medfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
mohammad saeidi
Position
Nursing Master of Science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shariati South St, Faculty of Nursing and Midwifery,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 44 3223 7816
Email
mohamadsaeidi670624@gmail.cim
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz jabraeli
Position
Phd.Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Shariati South St, Faculty of Nursing and Midwifery,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
Jabraelim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
mohammad saeidi
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shariati South St, Faculty of Nursing and Midwifery,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mohamadsaeidi670624@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
---
When the data will become available and for how long
---
To whom data/document is available
---
Under which criteria data/document could be used
---
From where data/document is obtainable
---
What processes are involved for a request to access data/document