The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety in children
Design
In this study, samples will be randomly divided into three groups using online software(https://www.randomizer.org/).
A quasi-experimental clinical trial study with a control, single-blind and randomized design.
Settings and conduct
The study will be conducted in one of the selected clinics under the supervision of Qom University of Medical Sciences. In this study, all 6-year-old children referred for vaccination will be randomly assigned to one of three control, intervention and placebo groups.
In this study, the researcher will be unaware of the type of intervention in the placebo and intervention groups.
Participants/Inclusion and exclusion criteria
inclusion
1. The child should be conscious and not have any identified problem in mental, hearing, sight, and verbal abilities.
2. No presence of scar, wound or damage in the point the device is put.
3. No usage of painkillers or anxiety-reducing medications in the past 8 hours.
4. No presence of cold sensitive diseases like Reynolds and local neural anesthesia.
exclusion:
No toleration the device by the child during the procedure
Intervention groups
1. in control group, vaccination procedure will be as the clinic’s normal routine.
2. in intervention group, vaccination procedure will be as the clinic’s normal routine with ice bag and switch on device.
3. in placebo group, vaccination procedure will be as the clinic’s normal routine with switch off device.
Main outcome variables
1. The score of pain in Wong-Baker Faces Pain Rating Scale
2. The score of anxiety in The Children Emotional Manifestation Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190603043812N1
Registration date:2019-09-08, 1398/06/17
Registration timing:prospective
Last update:2019-09-08, 1398/06/17
Update count:0
Registration date
2019-09-08, 1398/06/17
Registrant information
Name
Maryam khoshqadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3291 3346
Email address
mary_khoshqadam@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-13, 1398/06/22
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety in children
Public title
The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The child should be conscious and not have any identified problem in mental, hearing, sight, and verbal abilities.
No presence of scar, wound or damage in the point the device is put
No usage of painkillers or anxiety-reducing medications in the past 8 hours
No presence of cold sensitive diseases like Reynolds and local neural anesthesia.
6-year-old children who were clients of selected clinic which is under supervision of Qom University of Medical Sciences for vaccination and were qualified and eager to take part in the research.
Exclusion criteria:
No toleration the device by the child during the procedure
Age
From 6 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, samples are put in three groups randomly by the online application (https://www.randomizer.org/). 105 closed envelopes are offered to each child. There is a number between 1 and 105 in each envelope. Children are put in one of the three groups based on the numbers they chose.
Blinding (investigator's opinion)
Single blinded
Blinding description
Researcher is not informed about type of intervention and placebo group in this way: the vaccinator is told to inform the researcher to enter the room and fill in the survey if the child is in control group; if the child is in placebo or intervention group, the device (buzzy) is put on the child’s arm, then the researcher is asked to enter the room but does not know if the device is switched on or off.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.IUMS.REC.1397.248
Health conditions studied
1
Description of health condition studied
The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety in children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The score of pain in Wong-Baker Faces Pain Rating Scale
Timepoint
After vaccination, the child is asked to choose the smiley which corresponds to the severity of the pain they experienced. Supervising nurse also chooses the smiley corresponding to severity of child’s pain with a certain tool.
Method of measurement
Questioner
2
Description
The score of anxiety in The Children Emotional Manifestation Scale
Timepoint
This scale is completed in two steps by the supervising nurse (researcher). After choosing the group randomly and before entering the vaccination room, child’s anxiety is measured and recorded based on their emotional demonstration scale. Then the anxiety is measured and recorded immediately after disinfecting the injection point and during injection of the vaccine.
Method of measurement
Questioner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1.Preparing Buzzy device, ice bag, and other necessary tools for vaccination. 2.Placing the ice bag under the device. 3.Selecting injection point. 4.Placing the Buzzy device near the injection point where the needle penetrates (5 cm above the penetration point). 5.The wider end of the device is put parallel to penetration point. 6.The device is fixed by the vaccinator. 7.15 seconds before vaccination, the “switch on” button on the device is pushed. 8.Vaccine injection according to the clinic’s protocol. 9.Switching off the device after injection. 10.Disinfecting the device and ice bag (if it is not disposable) using cotton and 70% alcohol.
Category
N/A
2
Description
placebo group: 1. Preparing buzzy device and other necessary tools for vaccination.2. Selecting injection point.3. Placing the buzzy device near the injection point where the needle penetrates (5 cm above the penetration point).4. The wider end of the device is put parallel to penetration point.5. The device is fixed by the vaccinator. 6. Vaccine injection according to the clinic’s protocol. 7. Disinfecting the device and ice bag (if it is not disposable) using cotton and 70% alcohol.
Category
N/A
3
Description
Control group:1. The vaccinator washes their hand with soap before injection2. Injection point must be disinfected using cotton and 70% alcohol in circle shapes and from the center outward. The vaccination should be done after complete evaporation of the alcohol.3. Previously prepared alcohol-stained cottons must not be used.4. DPT vaccine (triple vaccine) is injected in left Deltoid muscle and is done as deep tissue injection. 5. To inject the DPT vaccine, syringe size G23 is used. ** in control group, vaccination procedure will be as the clinic’s normal routine.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Abdollahi health center
Full name of responsible person
Marayam Khoshqadam
Street address
Abdollahi health center, Tohid Ave
City
Qom
Province
Ghoum
Postal code
3718614497
Phone
+98 25 3882 4635
Email
mary_khoshqadam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Hemmat Highway, Next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6655 0200
Email
amotevalian@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Khoshqadam
Position
MS.pediatric nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 47, Hafez Ave., Saduqi Blvd
City
Qom
Province
Ghoum
Postal code
3716664867
Phone
+98 25 3291 3346
Email
mary_khoshqadam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sedigheh Khanjari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Care Research Center., School of Nursing and Midwifery and Medical Management and Information.,Rashid Yasimi Ave( across from Khatam Al-Anbia Hospital).,Vali Asr St (after Vanak Square),
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
0098 21 8867613
Email
sed.khanjari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Khoshqadam
Position
MS.pediatric nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 47, Hafez Ave., Saduqi Blvd
City
Qom
Province
Ghoum
Postal code
3716664867
Phone
+98 25 3291 3346
Email
mary_khoshqadam@yahoo.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