NCT06010771

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 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

June 30, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

July 3, 2023

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

26 days

First QC Date

June 30, 2023

Last Update Submit

July 30, 2024

Conditions

Aspiration; Syndrome

Keywords

Palliative careChildrenListening to StoriesWatching Cartoon FilmPain

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

    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.

    baseline and up to 4 weeks

Study Arms (2)

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.

Other: Listening to fairy talesOther: Watching Cartoon Film

Interventions

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.

Experimental Group
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.

Experimental Group

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • The family's desire to leave research.
  • Deterioration of the child's condition
  • The child's diagnosis of an additional chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum City Hospital

Erzurum, Central, 25090, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 36735635BACKGROUND

Related Links

MeSH Terms

Conditions

SyndromePain

Condition Hierarchy (Ancestors)

DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Gamze AKAY, 1

    Artvin Coruh University

    PRINCIPAL INVESTIGATOR

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

June 30, 2023

First Posted

August 25, 2023

Study Start

July 3, 2023

Primary Completion

July 29, 2023

Study Completion

July 29, 2023

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)