Comparison of the effect of whistling and using vibrating bees during blood sampling on pain and fear of children in the emergency department
Design
A musical doll in the shape of a bee with an approximate size of 15 cm with the ability to create vibration at the rate of 95-90 Hz was made, which is a portable cold bag with a linen cover in the form of a bracelet attached to it. When the child is with the parents, the nurse performing the blood sampling procedure, this musical bee doll, with the bag attached to it, is closed for 5 minutes, at a distance of about 5-10 cm above the blood sampling site, and in one minute The vibration end will be applied, then the child will enter the blood collection room with one of the parents and blood collection will be done immediately. In the second group, a bee-shaped balloon whistle with a long straw at the end will be given to the child and the child will be taught to die inside the straw 5 minutes before entering the room and whistle. Fill the air and the toy will be in the child's hand until the end of the blood collection and will continue to whistle during the blood collection process. Finally, the whistle will be given as a gift to the intervention group. The third group of the control group routine blood sampling.
Settings and conduct
The pediatric emergency department
Najaf health centers
Participants/Inclusion and exclusion criteria
Participants are children who need to be sampled during hospitalization, and if they are placed in two experimental groups, the fear and pain caused by the blood sampling process will probably be reduced.
Intervention groups
In the first intervention group, vibrating bees with a cold pack is used. The second group is the use of whistling during blood sampling. The third control group that blood sampling will be done with a routine program
Main outcome variables
Pain and fear caused by blood sampling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211211053351N1
Registration date:2022-01-02, 1400/10/12
Registration timing:registered_while_recruiting
Last update:2022-01-02, 1400/10/12
Update count:0
Registration date
2022-01-02, 1400/10/12
Registrant information
Name
sadeghi tahereh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 7313
Email address
sadeghit@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-28, 1400/10/07
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of whistling compared with Buzzy device during blood sampling on pain and fear in children’s emergency department
Public title
Effects of whistling compared with Buzzy device during blood sampling on pain and fear in children’s
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The child needs blood sampling.
At least one parent is present during blood sampling.
Be the first child injection experience at this reception.
The injection site of the inner crease of the elbow or forearm should be selected and there should be no scar or skin problem.
The child does not have sensory-neurological, vascular, hematological, verbal and cognitive disorders and chronic diseases.
• The child is awake before the intervention and has not received sedatives, sedatives or narcotics.
Before the intervention, the child's pain level should be below three with the Wong-Baker FACES tool.
The child and parents have informed consent to participate in the intervention.
Exclusion criteria:
Dissatisfaction of parents and children with research
Failure to draw blood for the first time
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The method used to generate a random allocation sequence is blocked. Block randomization ensures that there are no groups between the groups at any time interval during the randomization of a significant imbalance, and at each point the number of participants in each group is equal. Sampling in this research will be that sampling initially will be conducted in a "non-random" way for the purpose of children entering the research and assigning them to 3 groups (group: vibrating bee / whistling / control) will be random; In this way, the assignment of samples to intervention groups (vibrating bee / whistling / control) will be done by random assignment (lottery by blocking). In this intervention, we have three groups; first by assigning the code to the groups, the groups will be determined(Group A: vibration bee B: whistling C: control). 6 blocks with 3 pieces Characterized [(ABC(1)- ACB (2)-CAB (3)-BCA (4)- CBA (5)- BAC(6)]. Then, random numbers are selected between one to six (eg, 1, 4, 5, ...), and finally the list of treatment allocations based on random numbers will be determined.
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 Mashhad University of Medical Sciences
Street address
IbnSina 2St., School of Nursing and Midwifery, Khorasan Razavi, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-07-27, 1400/05/05
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.039
Health conditions studied
1
Description of health condition studied
Fear and pain caused by blood sampling
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain caused by blood sampling
Timepoint
Before, during and after blood sampling
Method of measurement
Children's pain will be assessed using the Wong Baker Smile Scale.
2
Description
Fear caused by blood sampling
Timepoint
Before, during and after blood sampling
Method of measurement
Fear of blood sampling will be measured by the CMFS Children's Fear Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use vibrating bees with cold packs In this study, a musical doll in the shape of a bee with an approximate size of 15 cm with the ability to create vibration at the rate of 95-90 Hz was made, which is a portable cold bag with a linen cover in the form of a bracelet attached to it. When the child is with the parents, the nurse performing the blood sampling procedure, this musical bee doll, with the bag attached to it, is closed for 5 minutes, at a distance of about 5-10 cm above the blood sampling site, and in one minute The vibration end will be applied, then the child will enter the blood collection room with one of the parents and blood collection will be done immediately.
Category
Treatment - Other
2
Description
Intervention group: Use a bee-shaped whistle when drawing bloodو before entering the blood collection room, a bee-shaped balloon whistle with a long straw at the end will be given to the child and the child will be taught to die inside the straw 5 minutes before entering the room and whistle. Fill the air and the toy will be in the child's hand until the end of the blood collection and will continue to whistle during the blood collection process. Finally, the whistle will be given as a gift to the intervention group.
Category
Treatment - Other
3
Description
The third group of the control group will enter the blood collection room with one of their parents according to the routine blood sampling process in the emergency department of the child and sampling will be done.
Research Vice Chancellor of Mashhad University of Medical Science
Full name of responsible person
Dr Majed Ghayour
Street address
Third floor, Vice Chancellor for Research and Technology, University of Medical Sciences, next to Hoveyzeh Cinema, Daneshgah St., Mashhad, Khorasan Razavi, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
GhayourM@mums.ac.ir
Web page address
https://www.mums.ac.ir
Grant name
4000366
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellor of Mashhad University of Medical Science
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
Tahereh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St., Daneshgah St., Daneshgah St., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 2081
Email
sadeghit@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St., Daneshgah St., Daneshgah St., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
13944 91388
Phone
+98 51 3841 2081
Email
sadeghit@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St., Daneshgah St., Daneshgah St., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
sadeghit@mums.ac.ir
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available