PainNCT05689411
The Effect of The Musical Toy Used During Peripheral Vascular Access on Children's Pain, Fear And Parents' Satisfaction
A study testing Musical Toy in people with Pain and Child, Only, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Pain, Child, Only, Parents
- What is being tested?
- Musical Toy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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,
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pain, Child, Only, Parents
- Being tested
- Musical Toy
- Keywords
- Pain, Fear, Children, Parent
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical ToyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 5 minutes after the procedure.
Secondary outcomes (2)
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.
Measured: 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.
Measured: 5 minutes after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start10 Jan 2022
- Primary completion30 Dec 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled experimental
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Kucuk Alemdar, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689411
- Sponsor's protocol ID
- KAEK291
- Status last verified
- Jun 2023
- First submitted
- 29 Dec 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of The Musical Toy Used During Peripheral Vascular Access on Children's Pain, Fear And Parents' Satisfaction
- ClinicalTrials.gov ID
- NCT05689411
- Acronym / sponsor ID
- KAEK291
- Conditions
- Pain, Child, Only, Parents
- Keywords
- Pain, Fear, Children, Parent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled experimental
| Arm | Type | Receives |
|---|---|---|
| Musical Toy Group | Experimental | Device: Musical ToyThe 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. |
| 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (3 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musical ToyThe 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 Group |
Primary outcome
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.
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.
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.
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.
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".
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".
2 secondary outcomes
Nurse-Patient Cooperation and Patient Parent Satisfaction Form
Time frame: 5 minutes before the procedure.
Nurse-Patient Cooperation and Patient Parent Satisfaction Form
Time frame: 5 minutes after the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musical Toy in people with Pain and Child, Only, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Emotional Indicator Scale (time frame: 5 minutes before the procedure.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.