NCT05483699

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

July 25, 2022

Last Update Submit

July 29, 2022

Conditions

Keywords

Blowing bubbleschildfearkaleidoscopepainsqueezing soft ball

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.

EXPERIMENTAL

The soft ball has a diameter of about 8-10 cm and can return to its old form when it is squeezed.

Other: Squeezing a ball

Using a kaleidoscope during intravenous cannulation reduces the child's pain and fear.

EXPERIMENTAL

Kaleidoscope 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.

Other: Kaleidoscope

Blowing bubbles during intravenous cannulation reduces the child's pain and fear.

EXPERIMENTAL

Children 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

Other: Blowing bubbles

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.

Squeezing a ball during intravenous cannulation reduces the child's pain and fear.

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

Blowing bubbles during intravenous cannulation reduces the child's pain and fear.

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

Using a kaleidoscope during intravenous cannulation reduces the child's pain and fear.

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

Didem Coşkun Şimşek

Elâzığ, Campus, 23000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations