Skip to main content
OpenTrials
Completed

NCT Number: NCT05689411

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Child, Only Neurologic Manifestations Parents Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dilek alemdar

Ordu, 52000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Musical Toy

Device

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.

Primary outcomes

  1. Children's Emotional Indicator Scale

    Time frame: 5 minutes before the procedure.

    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.

  2. Children's Emotional Indicator Scale

    Time frame: 5 minutes after the procedure.

    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.

  3. Child Fear Scale

    Time frame: 5 minutes before and after the procedure.

    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.

  4. Child Fear Scale

    Time frame: 5 minutes before the procedure.

    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. Qucher-Photographic and Numerical Rating Scale

    Time frame: 5 minutes before the procedure.

    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".

  6. Qucher-Photographic and Numerical Rating Scale

    Time frame: 5 minutes after the procedure.

    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".

Secondary outcomes

  1. Nurse-Patient Cooperation and Patient Parent Satisfaction Form

    Time frame: 5 minutes before the procedure.

    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.

  2. Nurse-Patient Cooperation and Patient Parent Satisfaction Form

    Time frame: 5 minutes after the procedure.

    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.

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 19, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.