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 | Not Yet Recruiting

• 1 other identifier: Pediatric Nursing
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheostomy; Care

Keywords

Palliative care; Children; Listening to stories; Watching Cartoons; Pain; Comfort

Outcome Measures

Primary Outcomes (2)

• FLACC Pain Scale

  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.

  baseline and up to 1 weeks

• Comfort Scale

  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.

  baseline and up to 1 weeks

Secondary Outcomes (2)

• Patient Identification Form

  Baseline Characteristics

• Physiological Parameter Record Form

  Baseline and up to 1 week

Study Arms (2)

Control Group

NO INTERVENTION

Routine tracheostomy care will be applied to the control group. No action will be taken.

Experimental Group

EXPERIMENTAL

During the tracheostomy care process, the experimental group will listen to fairy tales and watch cartoons.

Other: fairy tales; Other: mother's voice; Other: Cartoons

Interventions

fairy tales OTHER

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.

Experimental Group

mother's voice OTHER

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.

Experimental Group

Cartoons OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Erzurum City Hospital

Erzurum, Center, Turkey (Türkiye)

Location

Related Publications (1)

• Sarialioglu A, Kurudirek F, Oluc T. The effect of storybook reading on children's preoperative fear and anxiety levels: A randomized controlled study. Child Care Health Dev. 2023 Sep;49(5):906-913. doi: 10.1111/cch.13100. Epub 2023 Feb 8.

  PMID: 36735635 BACKGROUND

Related Links

• Randomized Controlled Trial

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatma GÜDÜCÜ TÜFEKCİ, 1

  Ataturk University

  STUDY CHAIR

Central Study Contacts

Fatma GÜDÜCÜ TÜFEKCİ, 1

CONTACT

+90 505 215 76 72; fatma.guducutufekci@atauni.edu.tr

Fatma GÜDÜCÜ TÜFEKCİ, 2

CONTACT

+90 505 215 76 72; fatma.guducutufekci@atauni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: October 7, 2025
• Study Start: November 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)