Efficiency of Three Different Methods in Reducing Pain in Children During Intravenous Cannulation

Child, Only Clinical Trial

Official title:

Comparison of the Efficiency of Three Different Methods in Reducing Pain and Fear in Children During Intravenous Cannulation: A Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05483699
• Other study ID #: intravenous cannulation
• Status: Completed
• Phase: N/A
• Start date: July 3, 2021
• Est. completion date: February 5, 2022

Study information

• Verified date: July 2022
• Source: Firat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 5, 2022
• Est. primary completion date: February 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

• parents who agreed to participate in the study

Exclusion Criteria:

• visually impaired child

• mentally retarded child

• speech impaired children

Related Conditions & MeSH terms

• Child, Only

Intervention

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.
• 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
• 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

Locations

Country	Name	City	State
Turkey	Didem Coskun Simsek	Elazig	Campus

Sponsors (1)

Lead Sponsor	Collaborator
Firat University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.