The Effect of an Audiobook and a Music-Movement Toy on Fear, Anxiety and Pain in Tracheostomy Care for Children in the Palliative Clinic

Study Overview
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Brief Summary
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The aim of this study was to determine the effect of audio book and musical-moving toy on fear, anxiety and pain in tracheostomy care of children in palliative clinic.

Detailed Description
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In children with receiving palliative care will be randomly divided into two groups: audiobook group and musical-moving toy. Interventions will be applied for 2 days, 1 times a day (2 sessions). No intervention will be applied to both groups besides audiobook or musical-moving toy intervention. The children will be assessed before, during and after. Pain, fear and anxiety due to tracheostomy care procedure will be evaluated using the Wong Baker Facial Pain Scale, Child Anxiety Scale-Stateness and Children's Fear Scale . In addition, the heart rate, respiration, blood pressure and SPO2 values of the children will be measured with the help of a bedside monitor.

Official Title
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The Effect of an Audiobook and a Music-Movement Toy on Fear, Anxiety and Pain in Tracheostomy Care for Children in the Palliative Clinic: A Randomized Controlled Trial

Conditions
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Tracheostomy Infection

Intervention / Treatment
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* Other: Listening to audiobook
* Other: Playing musical-moving toy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 6 months and 18 years Receiving inpatient treatment in paediatric palliative care service No visual and hearing abnormalities Exclusion Criteria: The family's desire to leave research. Deterioration of the child's condition

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Routine tracheostomy care will be applied to the control group. No action will be taken. | |
| Experimental: Experimental Group<br>During the tracheostomy care process, the experimental group will listen to audiobook and play with musical-moving toy. | Other: Listening to audiobook<br>* Audiobook by children will be chosen by child psychologists. The books will be played to children via tablet computers. The researcher has a fairy tale therapy certificate. The audiobook listening will start 5 minutes before the tracheostomy care process and will continue throughout the tracheostomy care process. Audiobook will be listen to children only one day.<br>Other: Playing musical-moving toy<br>* Musical-moving toy by children will be chosen by child psychologists. The toy will be played to children by the researcher. Playing musical-moving toy will start 5 minutes before the tracheostomy care process and will continue throughout the tracheostomy care process. The toy will be played to children only one day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Identification Form | In this form, there are questions about the child's age, gender, diagnosis of the disease, length of stay, and how long ago she received the current diagnosis. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wong Baker Facial Pain Scale | Wong Baker Facial Pain Scale was developed by Donna Wong and Connie Moran Baker in 1981. The scale is suitable for children aged 3-18 years. On the scale, there are facial expressions that the child can enjoy and like. Therefore, it is reported to give more accurate results. On the scale, 0, 2, 4, 6, 8, and 10 scores are available. 0 refers to no pain, while 10 points refer to the highest pain level. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative care, Children, Audiobook, Musical-moving toy, Pain, Fear, Anxiety