The Effects of Listening to Fairy Tales, Listening to Fairy Tales in Their Mothers' Voices, and Watching Cartoons on Pain, Comfort Levels, and Physiological Parameters During Tracheostomy Care in a Palliative Care Clinic

Not Applicable

Not yet recruiting

• Conditions: Tracheostomy; Care

• Registration Number: NCT07210346
• Lead Sponsor: Ataturk University

Brief Summary

This study aimed to determine the effects of listening to fairy tales, listening to fairy tales from the mother's voice, and watching cartoons on pain, comfort, and physiological parameters during tracheostomy care of children receiving palliative care.

Detailed Description

Seventeen volunteer children between the ages of 1 and 7 receiving palliative care will be randomly assigned to three groups: a storytelling group, a mother's voice storytelling group, and a cartoon group. Each intervention will be administered once a day for one week. There will be a one-week washout period between interventions, during which time the children will receive routine nursing care. No intervention other than the storytelling or cartoon intervention will be administered to all three groups. Children will be assessed before, during, and after the procedure. PAIN RELATED TO THE TRACEOSTOMY PROCEDURE will be assessed using the FLACC Pain Scale, and comfort will be assessed using the Child Comfort Scale. Additionally, the children's heart rate, respiration, blood pressure, tidal volume, and temperature will be measured using a bedside monitor.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Study Start: 2025-11-01
• Primary Completion: 2025-12-30
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Being in the 1-7 year old age group,
• Being inpatient in a pediatric palliative care unit,
• Having no visual or hearing abnormalities,
• Having a tracheostomy.

Exclusion Criteria

• The family's desire to withdraw from the study,
• The child's health condition deteriorates.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
FLACC Pain Scale	baseline and up to 1 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.
Comfort Scale	baseline and up to 1 weeks	It is a sedation and comfort scoring system that includes two physiological and six emotional stress criteria. While it assesses sedation patterns in ventilated children, the parameters assessed can also be considered indicators of pain. The patient child is assessed on six behavioral parameters (alertness, calmness-agitation, respiratory response, physical movement, muscle tone, and facial tension) and two physical parameters (blood pressure and heart rate) within two minutes. Each criterion is scored on a Likert-type scale from one to five. The assessment result is: 27-40 indicates light sedation, 17-26 indicates moderate sedation, and 8-16 indicates deep sedation. The comfort scale assesses the child's level of sedation and also influences pain and comfort levels.

Secondary Outcome Measures

Name	Time	Method
Patient Identification Form	Baseline Characteristics	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 1 week	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, Center, Turkey (Türkiye)