Tracheostomy InfectionNCT06121440
Musical-animated Toys and Audio Books in Pediatric Palliative Care.
A study testing Listening to audiobook and Playing musical-moving toy in people with Tracheostomy Infection, run by Gamze Akay at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of audio book and musical-moving toy on fear, anxiety and pain in tracheostomy care of children in palliative clinic. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Tracheostomy Infection
- What is being tested?
- Listening to audiobook and Playing musical-moving toy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2023to 8 Dec 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between the ages of 6 months and 18 years
- Receiving inpatient treatment in paediatric palliative care service
- No visual and hearing abnormalities
Who cannot join
- The family's desire to leave research.
- Deterioration of the child's condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Musical-Animated Toys and Audio Books on Fear, and Pain in the Tracheostomy Care of Children in the Palliative Care
The aim of this study was to determine the effect of audio book and musical-moving toy on fear, anxiety and pain in tracheostomy care of children in palliative clinic.
Read the detailed description
In children with receiving palliative care will be randomly divided into two groups: audiobook group and musical-moving toy. Interventions will be applied for 2 days, 1 times a day (2 sessions). No intervention will be applied to both groups besides audiobook or musical-moving toy intervention. The children will be assessed before, during and after. Pain, fear and anxiety due to tracheostomy care procedure will be evaluated using the Wong Baker Facial Pain Scale, Child Anxiety Scale-Stateness and Children's Fear Scale . In addition, the heart rate, respiration, blood pressure and SPO2 values of the children will be measured with the help of a bedside monitor.
- Conditions
- Tracheostomy Infection
- Being tested
- Listening to audiobook, Playing musical-moving toy
- Keywords
- Palliative care, Children, Audiobook, Musical-moving toy, Pain, Fear, Anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to audiobookOther
Audiobook by children will be chosen by child psychologists. The books will be played to children via tablet computers. The researcher has a fairy tale therapy certificate. The audiobook listening will start 5 minutes before the tracheostomy care process and will continue throughout the tracheostomy care process. Audiobook will be listen to children only one day.
Playing musical-moving toyOther
Musical-moving toy by children will be chosen by child psychologists. The toy will be played to children by the researcher. Playing musical-moving toy will start 5 minutes before the tracheostomy care process and will continue throughout the tracheostomy care process. The toy will be played to children only one day.
| 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 audiobook and play with musical-moving toy. Receives: Other: Listening to audiobook; Other: Playing musical-moving toy |
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
Secondary outcomes (1)
Wong Baker Facial Pain Scale
Wong Baker Facial Pain Scale was developed by Donna Wong and Connie Moran Baker in 1981. The scale is suitable for children aged 3-18 years. On the scale, there are facial expressions that the child can enjoy and like. Therefore, it is reported to give more accurate results. On the scale, "0", "2", "4", "6", "8", and "10" scores are available. "0" refers to no pain, while "10" points refer to the highest pain level.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start13 Nov 2023
- Primary completion20 Nov 2023
- Study completion8 Dec 2023
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 Tracheostomy InfectionStudies 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
- 16 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
- Türkan KADİROĞLU, 3, Study chair, Ataturk UniversityAysun ÖNCER, 4, Study chair, Erzurum City HospitalDöne KILIÇ BULUT, 5, Study chair, Erzurum City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121440
- Sponsor's protocol ID
- Pediatric Palliative Care
- Status last verified
- Jul 2024
- First submitted
- 2 Nov 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoag JA, Karst J, Bingen K, Palou-Torres A, Yan K. Distracting Through Procedural Pain and Distress Using Virtual Reality and Guided Imagery in Pediatric, Adolescent, and Young Adult Patients: Randomized Controlled Trial. J Med Internet Res. 2022 Apr 18;24(4):e30260. doi: 10.2196/30260.
PubMed 35436209
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Musical-Animated Toys and Audio Books on Fear, and Pain in the Tracheostomy Care of Children in the Palliative Care
- ClinicalTrials.gov ID
- NCT06121440
- Acronym / sponsor ID
- Pediatric Palliative Care
- Conditions
- Tracheostomy Infection
- Keywords
- Palliative care, Children, Audiobook, Musical-moving toy, Pain, Fear, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gamze AkayUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 8 Nov 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 was to determine the effect of audio book and musical-moving toy on fear, anxiety and pain in tracheostomy care of children in palliative clinic.
Detailed description
In children with receiving palliative care will be randomly divided into two groups: audiobook group and musical-moving toy. Interventions will be applied for 2 days, 1 times a day (2 sessions). No intervention will be applied to both groups besides audiobook or musical-moving toy intervention. The children will be assessed before, during and after. Pain, fear and anxiety due to tracheostomy care procedure will be evaluated using the Wong Baker Facial Pain Scale, Child Anxiety Scale-Stateness and Children's Fear Scale . In addition, the heart rate, respiration, blood pressure and SPO2 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 tracheostomy care will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Other: Listening to audiobook, Other: Playing musical-moving toyDuring the tracheostomy care process, the experimental group will listen to audiobook and play with musical-moving toy. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Between the ages of 6 months and 18 years
- Receiving inpatient treatment in paediatric palliative care service
- No visual and hearing abnormalities
Key exclusion criteria (2 listed)
- The family's desire to leave research.
- Deterioration of the child's condition
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 audiobookAudiobook by children will be chosen by child psychologists. The books will be played to children via tablet computers. The researcher has a fairy tale therapy certificate. The audiobook listening will start 5 minutes before the tracheostomy care process and will continue throughout the tracheostomy care process. Audiobook will be listen to children only one day. | Other | Experimental Group |
| Playing musical-moving toyMusical-moving toy by children will be chosen by child psychologists. The toy will be played to children by the researcher. Playing musical-moving toy will start 5 minutes before the tracheostomy care process and will continue throughout the tracheostomy care process. The toy will be played to children only one day. | 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.
1 secondary outcome
Wong Baker Facial Pain Scale
Time frame: baseline
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 31 Jul 2024.
- Results publication: PubMed 35436209Hoag JA, Karst J, Bingen K, Palou-Torres A, Yan K. Distracting Through Procedural Pain and Distress Using Virtual Reality and Guided Imagery in Pediatric, Adolescent, and Young Adult Patients: Randomized Controlled Trial. J Med Internet Res. 2022 Apr 18;24(4):e30260. doi: 10.2196/30260.
- A randomized controlled studyLink provided by the sponsor.
Related trials for Tracheostomy Infection
RecruitingObservational study
Early vs. Late Tracheostomy in Patients With Guillain -Barre Syndrome
Guillain Barre Syndrome, Mechanical Ventilation
Enrolling by invitation
Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children
Trachea Diseases, Tracheal Stenosis
Recruiting
PUSH-IT Continuing Enteral Feeds for Tracheostomy
Tracheostomy Complication, Critical Illness
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.
Türkan KADİROĞLU, 3 study chair
Ataturk University
Aysun ÖNCER, 4 study chair
Erzurum City Hospital
Döne KILIÇ BULUT, 5 study chair
Erzurum City Hospital
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 audiobook and Playing musical-moving toy in people with Tracheostomy Infection, 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 3 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: finished, as of the sponsor's last update on 31 Jul 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). 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 NCT06121440, 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 31 Jul 2024.