The Effect of Listening to Stories and Watching Cartoon Film on Pain in the Aspiration Process in Children Receiving Palliative Care

Not Applicable

Completed

• Conditions: Aspiration; Syndrome
• Interventions: Other: Listening to fairy tales; Other: Watching Cartoon Film

• Registration Number: NCT06010771
• Lead Sponsor: Gamze Akay

Brief Summary

The aim of this study is to determine the effect of listening to fairy tales and watching cartoons on pain in the aspiration process in play-age children receiving palliative care.

Detailed Description

15 voluntary children with receiving palliative care, aged between 1-3 years will be randomly divided into two groups: fairy tale group and cartoon group. Interventions will be applied for 3 weeks, 1 times a day (16 sessions). No intervention will be applied to both groups besides fairy tale or cartoon intervention. The children will be assessed before, during and after. PAIN DUE TO ASPIRATION PROCEDURE will be evaluated using the FLACC Pain Scale. In addition, the heart rate, respiration, blood pressure, tidal volume and fever values of the children will be measured with the help of a bedside monitor.

Study Timeline

• Study First Submitted: 2023-06-30
• Study Start: 2023-07-03
• Primary Completion: 2023-07-29
• Study Completion: 2023-07-29
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Being in the 1-3 age group
• Being in the palliative care service for at least 3 months
• Receiving inpatient treatment in the pediatric palliative care service
• Absence of visual and hearing anomalies
• No other chronic disease
• Having a tracheostomy

Exclusion Criteria

• The family's desire to leave research.
• Deterioration of the child's condition
• The child's diagnosis of an additional chronic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental Group	Listening to fairy tales	During the aspiration process, the experimental group will listen to fairy tales and watch cartoons.
Experimental Group	Watching Cartoon Film	During the aspiration process, the experimental group will listen to fairy tales and watch cartoons.

Primary Outcome Measures

Name	Time	Method
FLACC Pain Scale	baseline and up to 4 weeks	FLACC has reliability and validity to determine observational pain of children aged between 3 and 18 years during the medical procedures. This scale is preferred due to its implicity of application among children. It has five categories of behavior to rate pain, namely, facial expression, leg movement, activity, cry, and consolability. The scores of each category are between 0 and 2. The total scores can range from 0 to 10, defined as mild (1-3), moderate (4-6), and severe (7-10). The higher the score, the greater the pain.
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.
Physiological Parameter Record Form	baseline and up to 4 weeks	In this form, there are records of all physiological parameters including pulse and respiratory rate, body temperature, blood pressure, SpO2, tidal volume, and peak heart rate. If the value of each parameter is higher than the normal values, it indicates the presence of abnormal condition.; Pulse normal value range: 80-130/ Minute Blood pressure normal value range:92-44 mmHg Respiratory rate normal value range: 16-22/ Minute Body temperature normal value range: 36,4-38 degree SpO2 normal value range: %96-98 Tidal volume normal value range: 6-10 ml/kg

Trial Locations

Locations (1)

Erzurum City Hospital; 🇹🇷 Erzurum, Central, Turkey