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Starting soon Not applicable

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

NCT07210346 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-11-01
Last updated
2025-10-07

Condition(s) studied

TracheostomyCare

Investigational drug(s) / intervention(s)

fairy talesmother's voiceCartoons

fairy tales: The children's stories will be selected by child psychologists. The stories will be read by a story therapist and recorded on a voice recorder. The story playback will begin five minutes before the request begins and continue throughout the request process. The stories will be played for five days. Afterward, there will be a one-week detoxification period before moving on to the next intervention.

mother's voice: Children's stories will be selected by child psychologists. The stories will be read by the children's mothers and recorded on a voice recorder. Story repetition will begin five minutes before the request begins and continue throughout the request period. The stories will be listened to for five days. Following this, there will be a one-week detoxification period before moving on to the next intervention.

Cartoons: The cartoons children will watch will be selected by child psychologists. Children will be shown cartoons on tablets. Watching will begin five minutes before the request period and continue throughout the request period. Children will be shown cartoons for five days.

Study 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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
7 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Erzurum City Hospital Erzurum Center
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07210346 on ClinicalTrials.gov ↗ ← All trials in Turkey