NCT06121440

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

November 13, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2023

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

7 days

First QC Date

November 2, 2023

Last Update Submit

July 30, 2024

Conditions

Keywords

Palliative careChildrenAudiobookMusical-moving toyPainFearAnxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Secondary Outcomes (1)

  • Wong Baker Facial Pain Scale

    baseline

Other Outcomes (2)

  • Child anxiety Scale-State

    baseline

  • Child Fear Scale

    baseline

Study Arms (2)

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.

Other: Listening to audiobookOther: Playing musical-moving toy

Interventions

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.

Experimental Group

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.

Experimental Group

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • The family's desire to leave research.
  • Deterioration of the child's condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum City Hospital

Erzurum, Central, 25090, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Türkan KADİROĞLU, 3

    Ataturk University

    STUDY CHAIR
  • Aysun ÖNCER, 4

    Erzurum City Hospital

    STUDY CHAIR
  • Döne KILIÇ BULUT, 5

    Erzurum City Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 8, 2023

Study Start

November 13, 2023

Primary Completion

November 20, 2023

Study Completion

December 8, 2023

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations