The Effect of Listening to Stories and Watching Cartoon Film on Pain in the Aspiration Process in Children Receiving Palliative Care

July 30, 2024 updated by: Gamze Akay

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Central
      • Erzurum, Central, Turkey, 25090
        • Erzurum City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Routine aspiration will be applied to the control group. No action will be taken.
Experimental: Experimental Group
During the aspiration process, the experimental group will listen to fairy tales and watch cartoons.
Other: Listening to fairy tales
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.
Other: Watching Cartoon Film
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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
baseline and up to 4 weeks
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.
baseline and up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gamze Akay

Collaborators

Ataturk University

Investigators

  • Principal Investigator: Gamze AKAY, 1, Artvin Çoruh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Actual)

July 29, 2023

Study Completion (Actual)

July 29, 2023

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pediatric Nursing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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