Comparison the effect of stress ball squeezing and pinwheel blowing on the average score of pain and anxiety caused by intravenous catheter insertion in hospitalized school-aged children
Comparison the effect of stress ball squeezing and pinwheel blowing on the average score of pain and anxiety caused by intravenous catheter insertion in hospitalized school-aged children.
Design
Clinical trial with control group, with parallel groups, randomized, on 90 patients. It is used for randomization based on the 3-digit replacement block method.
Settings and conduct
The research environment is the children's internal departments of Namazi Hospital, Shiraz. The study is carried out as an intervention with two intervention and control groups, each group consisting of 30 people. The child's pain and anxiety are measured before and after the intervention.
Participants/Inclusion and exclusion criteria
Entry: consent and presence of parents, age 6-12 years, absence of pain and emergency conditions and neuropathy, no use of sedatives, alertness of the child. Failure to enter: failure in the first attempt to establish an intravenous line
Intervention groups
This study has two intervention groups and one control group.The stress ball squeezing group who squeeze the stress ball five minutes before and during the intravenous line insertion. The pinwheel blowing group who blow in the pinwheel for five minutes before and during the intravenous line insertion.children of the control group receive usual ward care.
Main outcome variables
Average score of pain and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240408061451N1
Registration date:2024-04-25, 1403/02/06
Registration timing:prospective
Last update:2024-04-25, 1403/02/06
Update count:0
Registration date
2024-04-25, 1403/02/06
Registrant information
Name
Reyhaneh Dehghan Dehnavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3828 4502
Email address
dehghan.reyhanehh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-05, 1403/03/16
Expected recruitment end date
2024-10-07, 1403/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of stress ball squeezing and pinwheel blowing on the average score of pain and anxiety caused by intravenous catheter insertion in hospitalized school-aged children
Public title
Comparison the effect of stress ball squeezing and pinwheel blowing on the average score of pain and anxiety caused by intravenous catheter insertion in hospitalized school-aged children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness of the child and his guardian to participate in the study
Age 6-12 years of both sexes
Not having any pain other than the pain of establishing an intravenous line
Absence of mental retardation or not being able to communicate and have full consciousness
Not having an urgent need to establish an intravenous line
Not having a seizure or any life-threatening emergency (cardiac or acute respiratory disease, etc.)
Not using narcotics, painkillers, non-steroidal anti-inflammatory drugs, sedatives, local anesthesia, general anesthesia, and anticonvulsant drugs in the last 24 hours
Not having neuropathy diseases
The presence of parents during the establishment of an intravenous line
At least 24 hours have passed since the child was hospitalized
Exclusion criteria:
Failure of the first attempt to establish an IV line
Non-continuing cooperation of the child in the intervention group to squeeze the stress ball or blow the pinwheel
Parents' unwillingness to continue the intervention
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of children is based on the 3-digit replacement block method, and the randomization list is based on random allocation and is prepared by the software for three groups A, B, and C, as follows.
ABC
ACB
B.C.A
BAC
CBA
CAB
C: Children in the control group A: Children in the stress ball squeezing group B: Children in the pinwheel blowing group
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
Faculties of Nursing and Midwifery, Management and Medical Information - Shiraz University of Medica
Street address
School of Nursing and Midwifery, Shiraz University of Medical Sciences, Namazi Square, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2024-02-26, 1402/12/07
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.153
Health conditions studied
1
Description of health condition studied
Pain caused by intravenous line insertion
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Anxiety caused by intravenous line insertion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
School-age child pain is measured using Oucher tool. The vertical table includes the numbers 0-100 on the left side of the photos. A score of 0 is no pain, a score of 1 to 29 is mild pain, a score of 30 to 69 is moderate pain, a score of 70 to 99 is severe pain, and a score of 100 is very severe pain.
Timepoint
Before and after the intravenous catheter insertion
Method of measurement
Oucher pain self-report instrument
2
Description
Wenham Picture Test is a self-report tool to determine anxiety. Total scores will be between 0 and 8. If the child's score is 4 or higher, he will be considered as an anxious child.
Timepoint
Before and after the intravenous catheter insertion
Method of measurement
Venham anxiety self-report instrument
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The stress ball squeezing group, 30 children who squeeze the stress ball five minutes before and during the intravenous line insertion. In this study, in order to have the same conditions in the study period for all three groups, an intravenous line is established by a nurse who is authorized to do this work and the intravenous line is established with only one attempt. First, after giving the necessary explanations and obtaining permission from the parent and the school-age child, the questionnaire containing demographic information will be completed by the researcher. The child will be taken to the intravenous line insertion room with the parent, and in order to measure the level of anxiety and pain, the anxiety and pain self-measurement scale will be completed before the intravenous line is inserted. Then, for five minutes prior to insertion of the IV catheter, distraction will begin using stress ball compression with the hand opposite to the IV line insertion hand. Then the catheter insertion will start and the diversion will continue until the end of the intravenous line. The duration of the venous line establishment will be calculated from the moment of needle insertion to the stage of fixing the angiocath. Immediately after the end of the intravenous line, pain and anxiety scores will be determined using Oucher Pain Scale, Venham Picture Test, respectively.
Category
Treatment - Other
2
Description
Intervention group: The pinwheel blowing group, 30 children who blow in a pinwheel for five minutes before and during the intravenous line insertion. In this study, in order to have the same conditions in the study period for all three groups, an intravenous line is established by a nurse who is authorized to do this work and the intravenous line is established with only one attempt. First, after giving the necessary explanations and obtaining permission from the parent and the school-age child, the questionnaire containing demographic information will be completed by the researcher. The child will be taken to the intravenous line insertion room with the parent, and in order to measure the level of anxiety and pain, the anxiety and pain self-measurement scale will be completed before the intravenous line is inserted. Then, for five minutes prior to insertion of the IV catheter, distraction will begin using blowing into the pinwheel with the hand opposite to the IV line insertion hand. Then the catheter insertion will start and the diversion will continue until the end of the intravenous line. The duration of the venous line establishment will be calculated from the moment of needle insertion to the stage of fixing the angiocath. Immediately after the end of the intravenous line, pain and anxiety scores will be determined using Oucher Pain Scale, Venham Picture Test, respectively.
Category
Treatment - Other
3
Description
Control group: 30 children in the control group receive the usual ward care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Ahmad Hosseinzadeh
Street address
Namazi Hospital,Namazi Square,Zand Street
City
Shiraz
Province
Fars
Postal code
13311-71936
Phone
+98 71 3647 4332
Email
nemazee_inf@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Qasemi
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Hadian Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shiraz University of Medical Sciences, Namazi Square, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
zhadian@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Hadian Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shiraz University of Medical Sciences, Namazi Square, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
zhadian@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reyhaneh Dehghan Dehnavi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shiraz University of Medical Sciences, Namazi Square, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
dehghan.reyhanehh@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not 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 data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The data access period starts 6 months after the publication of the results
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Conditions and analyzes that do not change the data.
From where data/document is obtainable
You can send messages to the mentioned emails(zhadian@sums.ac.ir ,dehghan.reyhanehh@gmail.com).
What processes are involved for a request to access data/document
The requester can send a message and introduce himself or herself and can access our data 6 months after the publication of our article.