Efficiency of Three Different Methods in Reducing Pain in Children During Intravenous Cannulation
Comparison of the Efficiency of Three Different Methods in Reducing Pain and Fear in Children During Intravenous Cannulation: A Randomised Controlled Study
1 other identifier
interventional
120
1 country
1
Brief Summary
Purpose: This study investigates the effects of squeezing a soft ball, using a kaleidoscope, or blowing bubbles during intravenous cannulation on the pain and fear of children between the ages of 4 and 6. Design and Methods: This study is a randomised controlled study. In the study, there were 30 children in the soft ball group, 30 children in the kaleidoscope group, 30 children in the bubbles group, and 30 children in the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2022
CompletedFirst Submitted
Initial submission to the registry
July 25, 2022
CompletedFirst Posted
Study publicly available on registry
August 2, 2022
CompletedAugust 2, 2022
July 1, 2022
7 months
July 25, 2022
July 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
assessing fear during intravenous cannula
Children's Fear Scale: The scale was developed by McMurtry et al. to find out the anxiety levels of children between 4 and 10 years of age (McCarthy et al., 2010). There are five face pictures in the scale. Anxiety level is scored between "0 and 4". 0 indicates "no anxiety", while a scared face is scored 4 and indicates "too much anxiety". After the intravenous cannulation procedure ended, a researcher and parents filled Children's Fear Scale separately and independently to find out fear experienced by the child during the procedure.
3-5 minutes.
assessing pain during intravenous cannula
Faces Pain Scale-Revised: The scale developed by Bieri et al. is used to evaluate the pain levels of children between the ages of 4 and 17 (Bieri, Reeve, Champion, Addicoat, \& Ziegler, 1990). There are pictures of 6 faces in the scale. Level of pain is evaluated as "0,2,4,6,8,10". The face on the leftmost side is given a score of 0 and interpreted as "no pain", while the face on the rightmost side is given a score of 10 and interpreted as "a lot of pain". Pain severity increases as score increases. After the intravenous cannulation procedure ended, a researcher and parents filled Faces Pain Scale separately and independently to find out pain experienced by the child during the procedure.
3-5 minutes.
Study Arms (3)
Squeezing a ball during intravenous cannulation reduces the child's pain and fear.
EXPERIMENTALThe soft ball has a diameter of about 8-10 cm and can return to its old form when it is squeezed.
Using a kaleidoscope during intravenous cannulation reduces the child's pain and fear.
EXPERIMENTALKaleidoscope includes shapes of flowers and mirrors in the shape of triangle placed with an angle of 600. While rotating one of the cylinders, various shapes and colourful eyes are formed when viewed with one eye. When the kaleidoscope is rotated, the patterns look different all the time because the colourful parts are moving, attracting the child's attention.
Blowing bubbles during intravenous cannulation reduces the child's pain and fear.
EXPERIMENTALChildren in this group were shown bubble blower before intravenous cannulation and they were shown how bubbles formed and how to blow. Children blew bubbles during intravenous cannulation
Interventions
The children in the squeezing soft ball group were given the ball before the procedure. They were told to squeeze and loosen the ball with the hand that was not used for the procedure while intravenous cannula was being inserted.
The children in the blowing bubble group were shown the bubble blower before intravenous cannulation and they were told how bubbles were formed and how they would blow. During intravenous cannulation, the child blew the blower
Children in the Kaleidoscope group were given the kaleidoscope before intravenous cannulation and they were shown how to use it. The children were told to look at the kaleidoscope during the procedure until the procedure ended
Eligibility Criteria
You may qualify if:
- parents who agreed to participate in the study
You may not qualify if:
- visually impaired child
- mentally retarded child
- speech impaired children
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Firat Universitylead
Study Sites (1)
Didem Coşkun Şimşek
Elâzığ, Campus, 23000, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 25, 2022
First Posted
August 2, 2022
Study Start
July 3, 2021
Primary Completion
February 5, 2022
Study Completion
February 5, 2022
Last Updated
August 2, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share