Musical-animated Toys and Audio Books in Pediatric Palliative Care.

Not Applicable

Completed

• Conditions: Tracheostomy Infection
• Interventions: Other: Listening to audiobook; Other: Playing musical-moving toy

• Registration Number: NCT06121440
• Lead Sponsor: Gamze Akay

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-08
• Study Start: 2023-11-13
• Primary Completion: 2023-11-20
• Study Completion: 2023-12-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Between the ages of 6 months and 18 years
2. Receiving inpatient treatment in paediatric palliative care service
3. No visual and hearing abnormalities

Exclusion Criteria

1. The family's desire to leave research.
2. Deterioration of the child's condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental Group	Playing musical-moving toy	During the tracheostomy care process, the experimental group will listen to audiobook and play with musical-moving toy.
Experimental Group	Listening to audiobook	During the tracheostomy care process, the experimental group will listen to audiobook and play with musical-moving toy.

Primary Outcome Measures

Name	Time	Method
Patient Identification Form	baseline	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.

Secondary Outcome Measures

Name	Time	Method
Wong Baker Facial Pain Scale	baseline	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.

Trial Locations

Locations (1)

Erzurum City Hospital; 🇹🇷 Erzurum, Central, Turkey