Aspiration; SyndromeNCT06010771
The Effect of Listening to Stories and Watching Cartoon Film on Pain in the Aspiration Process in Children Receiving Palliative Care
A study testing Listening to fairy tales and Watching Cartoon Film in people with Aspiration; Syndrome, run by Gamze Akay at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of listening to fairy tales and watching cartoons on pain in the aspiration process in play-age children receiving palliative care. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Aspiration; Syndrome
- What is being tested?
- Listening to fairy tales and Watching Cartoon Film
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2023to 29 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being in the 1-3 age group
- Being in the palliative care service for at least 3 months
- Receiving inpatient treatment in the pediatric palliative care service
- Absence of visual and hearing anomalies
- No other chronic disease
- Having a tracheostomy
Who cannot join
- The family's desire to leave research.
- Deterioration of the child's condition
- The child's diagnosis of an additional chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Listening to Stories and Watching Cartoon Film on Pain in the Aspiration Process in Playing Age Children Receiving Palliative Care: A Randomized Controlled Trial
The aim of this study is to determine the effect of listening to fairy tales and watching cartoons on pain in the aspiration process in play-age children receiving palliative care.
Read the detailed description
15 voluntary children with receiving palliative care, aged between 1-3 years will be randomly divided into two groups: fairy tale group and cartoon group. Interventions will be applied for 3 weeks, 1 times a day (16 sessions). No intervention will be applied to both groups besides fairy tale or cartoon intervention. The children will be assessed before, during and after. PAIN DUE TO ASPIRATION PROCEDURE will be evaluated using the FLACC Pain Scale. In addition, the heart rate, respiration, blood pressure, tidal volume and fever values of the children will be measured with the help of a bedside monitor.
- Conditions
- Aspiration; Syndrome
- Being tested
- Listening to fairy tales, Watching Cartoon Film
- Keywords
- Palliative care, Children, Listening to Stories, Watching Cartoon Film, Pain
- Medical subject headings
- Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to fairy talesOther
Fairy tales by children will be chosen by child psychologists. Tales will be read to the children by the researcher. The researcher has a fairy tale therapy certificate. The tale reading will start 5 minutes before the aspiration process and will continue throughout the aspiration process. Tales will be read to children every other day. This process will continue for 3 weeks.
Watching Cartoon FilmOther
The cartoons that children will watch will be preferred by child psychologists. Children will be watched cartoons with the help of tablets. Watching cartoons will start 5 minutes before the aspiration process and will continue throughout the aspiration process. Children will be shown cartoons every other day. This process will continue for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Routine aspiration will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | During the aspiration process, the experimental group will listen to fairy tales and watch cartoons. Receives: Other: Listening to fairy tales; Other: Watching Cartoon Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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 4 weeks
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 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start3 Jul 2023
- Primary completion29 Jul 2023
- Study completion29 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aspiration; SyndromeStudies of the same condition, open and under way.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamze Akay
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor-investigator, Gamze Akay, Artvin Coruh University
- Investigators
- Gamze AKAY, 1, Principal investigator, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010771
- Sponsor's protocol ID
- Pediatric Nursing
- Status last verified
- Jul 2024
- First submitted
- 30 Jun 2023
- Last updated
- 1 Aug 2024
- 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 36735635Akay G, Guducu Tufekci F. Storytelling Intervention Relieved Pain During Tracheostomy Suction in Children Under Palliative Care: A Randomised Controlled Trial. Scand J Caring Sci. 2026 Mar;40(1):e70182. doi: 10.1111/scs.70182.
PubMed 41588469
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to Stories and Watching Cartoon Film on Pain in the Aspiration Process in Playing Age Children Receiving Palliative Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06010771
- Acronym / sponsor ID
- Pediatric Nursing
- Conditions
- Aspiration; Syndrome
- Keywords
- Palliative care, Children, Listening to Stories, Watching Cartoon Film, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Gamze AkayUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 29 Jul 2023 (actual)
- Study completion
- 29 Jul 2023 (actual)
- First posted
- 25 Aug 2023 (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.
The aim of this study is to determine the effect of listening to fairy tales and watching cartoons on pain in the aspiration process in play-age children receiving palliative care.
Detailed description
15 voluntary children with receiving palliative care, aged between 1-3 years will be randomly divided into two groups: fairy tale group and cartoon group. Interventions will be applied for 3 weeks, 1 times a day (16 sessions). No intervention will be applied to both groups besides fairy tale or cartoon intervention. The children will be assessed before, during and after. PAIN DUE TO ASPIRATION PROCEDURE will be evaluated using the FLACC Pain Scale. In addition, the heart rate, respiration, blood pressure, tidal volume and fever values of the children will be measured with the help of 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 aspiration will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Other: Listening to fairy tales, Other: Watching Cartoon FilmDuring the aspiration process, the experimental group will listen to fairy tales and watch cartoons. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Being in the 1-3 age group
- Being in the palliative care service for at least 3 months
- Receiving inpatient treatment in the pediatric palliative care service
- Absence of visual and hearing anomalies
- No other chronic disease
Key exclusion criteria (3 listed)
- The family's desire to leave research.
- Deterioration of the child's condition
- The child's diagnosis of an additional chronic disease
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 |
|---|---|---|
| Listening to fairy talesFairy tales by children will be chosen by child psychologists. Tales will be read to the children by the researcher. The researcher has a fairy tale therapy certificate. The tale reading will start 5 minutes before the aspiration process and will continue throughout the aspiration process. Tales will be read to children every other day. This process will continue for 3 weeks. | Other | Experimental Group |
| Watching Cartoon FilmThe cartoons that children will watch will be preferred by child psychologists. Children will be watched cartoons with the help of tablets. Watching cartoons will start 5 minutes before the aspiration process and will continue throughout the aspiration process. Children will be shown cartoons every other day. This process will continue for 3 weeks. | Other | Experimental Group |
Primary outcome
Patient Identification Form
Time frame: baseline
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
Time frame: baseline and up to 4 weeks
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
FLACC Pain Scale
Time frame: baseline and up to 4 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: 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.
- Derived from this study: PubMed 41588469Akay G, Guducu Tufekci F. Storytelling Intervention Relieved Pain During Tracheostomy Suction in Children Under Palliative Care: A Randomised Controlled Trial. Scand J Caring Sci. 2026 Mar;40(1):e70182. doi: 10.1111/scs.70182.
- A randomized controlled studyLink 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. This study is not recruiting at the moment.
Gamze AKAY, 1 principal investigator
Artvin Coruh 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 Listening to fairy tales and Watching Cartoon Film in people with Aspiration; Syndrome, run by Gamze Akay 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 1 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Identification Form (time frame: baseline). The study lists 3 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 NCT06010771, which also lists 2 linked publications.
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 1 Aug 2024.