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NCT Number: NCT07210346

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

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.

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Key information

Conditions

Tracheostomy Care Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. FLACC Pain Scale

    Time frame: 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.

  2. Comfort Scale

    Time frame: 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 outcomes

  1. Patient Identification Form

    Time frame: 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.

  2. Physiological Parameter Record Form

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma GÜDÜCÜ TÜFEKCİ, 1

CONTACT

[email protected]

+90 505 215 76 72

Fatma GÜDÜCÜ TÜFEKCİ, 2

CONTACT

[email protected]

+90 505 215 76 72

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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