TracheostomyNCT07210346
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
A study testing fairy tales, mother's voice and Cartoons in people with Tracheostomy and Care, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Tracheostomy, Care
- What is being tested?
- fairy tales, mother's voice and Cartoons
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- The family's desire to withdraw from the study,
- The child's health condition deteriorates.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erzurum City Hospital
Erzurum, Center
Aysun ÖNCER, +90 544 839 84 16, hamitoncer@gmail.com
About this study
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.
Read the 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.
- Conditions
- Tracheostomy, Care
- Being tested
- fairy tales, mother's voice, Cartoons
- Keywords
- Palliative care, Children, Listening to stories, Watching Cartoons, Pain, Comfort
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fairy talesOther
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 voiceOther
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.
CartoonsOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: fairy tales; Other: mother's voice; Other: Cartoons |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline and up to 1 weeks
Secondary outcomes (2)
Patient Identification Form
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.
Measured: Baseline Characteristics
Physiological Parameter Record Form
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
Measured: Baseline and up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Güdücü Tüfekci, Ataturk University
- Investigators
- Fatma GÜDÜCÜ TÜFEKCİ, 1, Study chair, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210346
- Sponsor's protocol ID
- Pediatric Nursing
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36735635
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07210346
- Acronym / sponsor ID
- Pediatric Nursing
- Conditions
- Tracheostomy, Care
- Keywords
- Palliative care, Children, Listening to stories, Watching Cartoons, Pain, Comfort
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Routine tracheostomy care will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Other: fairy tales, Other: mother's voice, Other: CartoonsDuring the tracheostomy care process, the experimental group will listen to fairy tales and watch cartoons. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- The family's desire to withdraw from the study,
- The child's health condition deteriorates.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fairy talesThe 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. | Other | Experimental Group |
| mother's voiceChildren'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. | Other | Experimental Group |
| CartoonsThe 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. | Other | Experimental Group |
Primary outcome
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.
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.
2 secondary outcomes
Patient Identification Form
Time frame: Baseline Characteristics
Physiological Parameter Record Form
Time frame: Baseline and up to 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Results publication: PubMed 36735635Sarialioglu 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.
- Randomized Controlled TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatma GÜDÜCÜ TÜFEKCİ, 1 study chair
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fairy tales, mother's voice and Cartoons in people with Tracheostomy and Care, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma GÜDÜCÜ TÜFEKCİ, 1 (+90 505 215 76 72, fatma.guducutufekci@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC Pain Scale (time frame: baseline and up to 1 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07210346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.