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

June 18, 2023 updated by: Dilek Kucuk Alemdar, T.C. ORDU ÜNİVERSİTESİ
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Ordu, Turkey, 52000
        • Dilek alemdar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 minutes before the procedure.
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.
5 minutes after the procedure.
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.
5 minutes before and after the procedure.
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 minutes before the procedure.
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".
5 minutes before the procedure.
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".
5 minutes after the procedure.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
5 minutes before the procedure.
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.
5 minutes after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
T.C. ORDU ÜNİVERSİTESİ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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