The Effect of The Musical Toy Used During Peripheral Vascular Access on Children's Pain, Fear And Parents' Satisfaction

The research was carried out as a randomized controlled experimental study in order to examine the effects of the child's pain, fear and parent's satisfaction before and after vascular access with a musical toy-xylophone, which is used as a distraction technique for the preparation of the 3-6 year old child hospitalized in the pediatric clinic.

Study Overview

• Status: Completed
• Conditions: Pain; Parents; Child, Only
• Intervention / Treatment: Device: Musical Toy

Detailed Description

The population of the study consists of children aged 3-6 years who applied to Durağan Şehit Hakan Tanrıkulu State Hospital Pediatric Service between January 2022 and December 2022 and needed vascular access. The sample of the study consisted of 70 children (control: 35, experiment: 35) who met the case selection criteria. Child and Parent Descriptive Information Form, Child Fear Scale (CFS), Children's Emotional Indicator Scale (CEIS), QUCHER Photographic and Numerical Rating Form (QUCHER), and Nurse-Patient Collaboration Level and Parent Satisfaction Form were used. While the children in the experimental group were playing with a musical toy with their parents, peripheral vascular access was performed.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ordu, Turkey, 52000
    • Dilek alemdar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The child is between 3-6 years old,
• Volunteering of parents and children to participate in the research,
• The child does not come to the hospital with acute pain,

Exclusion Criteria:

• The child has a hearing, vision and mental problem,
• The child and the parent do not understand and speak Turkish easily,
• Absence of a primary caregiver,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Musical Toy Group; The child and his parents in the experimental group were distracted by playing with the xylophone, a musical toy, 5 minutes before the peripheral vascular access procedure. The xylophone is a percussion wooden toy. There are two wooden bars on the xylophone that make melodious sounds when the metal plates are struck. The xylophone toy was introduced to the child and the parent, and they were given the opportunity to examine it. Before the procedure, one of the wooden sticks of the toy was given to the child and the other to the parent. Before, during and after the procedure, the child and his parents played together by making a melodic sound from the musical toy xylophone. While the child and his parents were playing with the toy, the researcher attached a tourniquet to the appropriate extremity of the child and determined the vein to which the vascular access would be performed.	Device: Musical Toy; The child and his parents in the experimental group were distracted by playing with the xylophone, a musical toy, 5 minutes before the peripheral vascular access procedure. The xylophone is a percussion wooden toy. There are two wooden bars on the xylophone that make melodious sounds when the metal plates are struck. The xylophone toy was introduced to the child and the parent, and they were given the opportunity to examine it. Before the procedure, one of the wooden sticks of the toy was given to the child and the other to the parent. Before, during and after the procedure, the child and his parents played together by making a melodic sound from the musical toy xylophone. While the child and his parents were playing with the toy, the researcher attached a tourniquet to the appropriate extremity of the child and determined the vein to which the vascular access would be performed.
No Intervention: Control Group; No distraction technique was applied to the children in the control group before the vascular access procedure. After the procedure was explained according to the child's developmental level, the researcher applied the procedure to open a vascular access in accordance with the institutional policies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Emotional Indicator Scale	children's emotional behaviors during stressful medical procedures.It takes a value between 1 and 5 for each category. The total score that can be obtained from the scale varies between 5-25. As the scores obtained from the scale increase, negative emotional indicators increase.	5 minutes before the procedure.
Children's Emotional Indicator Scale	children's emotional behaviors during stressful medical procedures.It takes a value between 1 and 5 for each category. The total score that can be obtained from the scale varies between 5-25. As the scores obtained from the scale increase, negative emotional indicators increase.	5 minutes after the procedure.
Child Fear Scale	The CFS consists of five drawn facial expressions ranging from a neutral expressioanxiety level of children.The mean score of the CFS is 1.9 ± 0.1 (min=0, max=4). The CLS can also be scored by the parent and the researcher.	5 minutes before and after the procedure.
Child Fear Scale	The CFS consists of five drawn facial expressions ranging from a neutral expressioanxiety level of children.The mean score of the CFS is 1.9 ± 0.1 (min=0, max=4). The CLS can also be scored by the parent and the researcher. anxiety level of children.	5 minutes before the procedure.
Qucher-Photographic and Numerical Rating Scale	The Qucher scale can be used in children aged 3-12 years.Pain intensity is evaluated from 0 as "pain-no pain" and up to 10 as "the greatest pain-pain you can have".	5 minutes before the procedure.
Qucher-Photographic and Numerical Rating Scale	The Qucher scale can be used in children aged 3-12 years.Pain intensity is evaluated from 0 as "pain-no pain" and up to 10 as "the greatest pain-pain you can have".	5 minutes after the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nurse-Patient Cooperation and Patient Parent Satisfaction Form	The Nurse-Patient Collaboration section consists. The patient is asked to rate how his or her compliance with the procedure is between 0 and 10 points. 0 represents the worst fit and 10 the best fit.questions directed to the nurse performing the procedure.	5 minutes before the procedure.
Nurse-Patient Cooperation and Patient Parent Satisfaction Form	The Nurse-Patient Collaboration section consists. The patient is asked to rate how his or her compliance with the procedure is between 0 and 10 points. 0 represents the worst fit and 10 the best fit.questions directed to the nurse performing the procedure.	5 minutes after the procedure.

Collaborators and Investigators

• Sponsor: T.C. ORDU ÜNİVERSİTESİ

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Children; Fear; Parent
• Other Study ID Numbers: KAEK291

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