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NCT Number: NCT06121440

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

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.

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Key information

Conditions

Tracheostomy Infection Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erzurum City Hospital

Erzurum, Central, 25090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Listening to audiobook

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

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.

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.

Secondary outcomes

  1. Wong Baker Facial Pain Scale

    Time frame: baseline

    Wong Baker Facial Pain Scale was developed by Donna Wong and Connie Moran Baker in 1981. The scale is suitable for children aged 3-18 years. On the scale, there are facial expressions that the child can enjoy and like. Therefore, it is reported to give more accurate results. On the scale, "0", "2", "4", "6", "8", and "10" scores are available. "0" refers to no pain, while "10" points refer to the highest pain level.

Other outcomes

  1. Child anxiety Scale-State

    Time frame: baseline

    "Child Anxiety Scale-State" scale developed by Ersig et al. in 2013 measures the state anxiety of children aged 4-10 years. In 2017, Gerceker et al. carried out Turkish validity study for the scale. CAS-S (State) is designed as a thermometer. At the bottom is the bulb chamber, and upward are horizontal lines. Each horizontal line represents a score, and the thermometer has 10 points. The bulb chamber at the bottom is 0 points and indicates that there is no anxiety. It is interpreted as the rise of anxiety as it rises upwards. The peak is worth 10 points and refers to the highest anxiety.

  2. Child Fear Scale

    Time frame: baseline

    This scale was developed by McMurtry et al. in 2011. In 2018, Gerceker et al. carried out a Turkish validity study for the scale. The scale is aimed at children aged 5-10 years. The facial muscle changes in fearful expressions are drawn by a graphic artist based on photos of frightened faces. In this scale, the child is shown a scale containing five facial expressions that are evaluated between 0 and 4 points. While 0 point refers to no fear; 4 points refers to the highest fear.

Sponsors and collaborators

Lead sponsor

Gamze Akay

Other

Collaborators

  • Ataturk University

Registry information

Official study title

The Effect of Musical-Animated Toys and Audio Books on Fear, and Pain in the Tracheostomy Care of Children in the Palliative Care

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2023
Registry last updated
Jul 31, 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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