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

NCT05689411 | Completed

• 1 other identifier: KAEK291
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Child, Only; Parents

Keywords

Pain; Fear; Children; Parent

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Nurse-Patient Cooperation and Patient Parent Satisfaction Form

  5 minutes before the procedure.

• Nurse-Patient Cooperation and Patient Parent Satisfaction Form

  5 minutes after the procedure.

Study Arms (2)

Musical Toy Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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.

Musical Toy Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Dilek alemdar

Ordu, 52000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the database of the research will be created by a university graduate statistician working in a statistical center independent of the research, apart from the researcher.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: randomized controlled experimental

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 19, 2023
• Study Start: January 10, 2022
• Primary Completion: December 30, 2022
• Study Completion: February 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)