Musical-animated Toys and Audio Books in Pediatric Palliative Care.

NCT ID: NCT06121440

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-13

Study Completion Date

2023-12-08

Brief Summary

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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

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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

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Tracheostomy Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental Group

During the tracheostomy care process, the experimental group will listen to audiobook and play with musical-moving toy.

Group Type EXPERIMENTAL

Listening to audiobook

Intervention Type OTHER

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 toy

Intervention Type OTHER

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.

Interventions

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Listening to audiobook

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.

Intervention Type OTHER

Playing musical-moving toy

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Between the ages of 6 months and 18 years
2. Receiving inpatient treatment in paediatric palliative care service
3. No visual and hearing abnormalities

Exclusion Criteria

1. The family's desire to leave research.
2. Deterioration of the child's condition
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role collaborator

Gamze Akay

OTHER

Sponsor Role lead

Responsible Party

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Gamze Akay

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Türkan KADİROĞLU, 3

Role: STUDY_CHAIR

Ataturk University

Aysun ÖNCER, 4

Role: STUDY_CHAIR

Erzurum City Hospital

Döne KILIÇ BULUT, 5

Role: STUDY_CHAIR

Erzurum City Hospital

Locations

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Erzurum City Hospital

Erzurum, Central, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 35436209 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/35436209/

A randomized controlled study

Other Identifiers

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Pediatric Palliative Care

Identifier Type: -

Identifier Source: org_study_id

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