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

Tracheostomy Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06121440
• Other study ID #: Pediatric Palliative Care
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: December 8, 2024

Study information

• Verified date: November 2023
• Source: Artvin Coruh University
• Contact: Gamze AKAY, 1
• Phone: 05314536661
• Email: gamzeakay_25[@]artvin.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 17
• Est. completion date: December 8, 2024
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Tracheostomy Infection

Intervention

Other:
• Listening to audiobook
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.
• Playing musical-moving toy
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.

Locations

Country	Name	City	State
Turkey	Erzurum City Hospital	Erzurum	Central

Sponsors (2)

Lead Sponsor	Collaborator
Gamze Akay	Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Hoag JA, Karst J, Bingen K, Palou-Torres A, Yan K. Distracting Through Procedural Pain and Distress Using Virtual Reality and Guided Imagery in Pediatric, Adolescent, and Young Adult Patients: Randomized Controlled Trial. J Med Internet Res. 2022 Apr 18;2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child anxiety Scale-State	"Child Anxiety Scale-State" scale developed by Ersig et al. in 2013 measures the state anxiety of children aged 4-10 years. In 2017, Gerceker et al. carried out Turkish validity study for the scale. CAS-S (State) is designed as a thermometer. At the bottom is the bulb chamber, and upward are horizontal lines. Each horizontal line represents a score, and the thermometer has 10 points. The bulb chamber at the bottom is 0 points and indicates that there is no anxiety. It is interpreted as the rise of anxiety as it rises upwards. The peak is worth 10 points and refers to the highest anxiety.	baseline
Other	Child Fear Scale	This scale was developed by McMurtry et al. in 2011. In 2018, Gerceker et al. carried out a Turkish validity study for the scale. The scale is aimed at children aged 5-10 years. The facial muscle changes in fearful expressions are drawn by a graphic artist based on photos of frightened faces. In this scale, the child is shown a scale containing five facial expressions that are evaluated between 0 and 4 points. While 0 point refers to no fear; 4 points refers to the highest fear.	baseline
Primary	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	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

External Links

•   A randomized controlled study