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Completed

NCT Number: NCT06010771

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

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.

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Key information

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erzurum City Hospital

Erzurum, Central, 25090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Listening to fairy tales

Other

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.

Watching Cartoon Film

Other

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Gamze Akay

Other

Collaborators

  • Ataturk University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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