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

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.

Study Overview

• Status: Completed
• Conditions: Child, Only
• Intervention / Treatment: Other: Squeezing a ball; Other: Kaleidoscope; Other: Blowing bubbles

Detailed Description

15 minutes before the intravenous cannulation procedure, the second researcher interviewed the parents and the children in squeezing soft ball, kaleidoscope, blowing bubbles and control groups separately and filled in descriptive information form and Children's Fear Scale. After randomization, the second researcher, the child and the parent went to the blood collection room for the procedure. 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. 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. Routine procedures were applied on the children in the control group without any interventions. Inserting the intravenous cannula took 3-5 minutes. The procedure was carried out in the same room by the same nurse for four of the groups. After the intravenous cannulation procedure ended, a researcher and parents filled in Faces Pain Scale-Revised and Children's Fear Scale separately and independently to find out the level of pain and fear experienced by the child during the procedure.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Campus
    • Elazığ, Campus, Turkey, 23000
      • Didem Coşkun Şimşek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• parents who agreed to participate in the study

Exclusion Criteria:

• visually impaired child
• mentally retarded child
• speech impaired children

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Squeezing a ball during intravenous cannulation reduces the child's pain and fear.; 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; 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.
Experimental: Using a kaleidoscope during intravenous cannulation reduces the child's pain and fear.; 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; 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
Experimental: Blowing bubbles during intravenous cannulation reduces the child's pain and fear.; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Firat University

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2021
• Primary Completion (Actual): February 5, 2022
• Study Completion (Actual): February 5, 2022

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: pain; child; fear; Blowing bubbles; kaleidoscope; squeezing soft ball
• Other Study ID Numbers: intravenous cannulation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No