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NCT Number: NCT06668311

Play Dough and Picture Books: Reducing Anxiety and Fear in 3-6-Year-Olds During Nebulizer Treatment

This randomized controlled trial aims to evaluate the effects of play dough and picture books on physiological parameters, anxiety, and fear levels in children aged 3-6 undergoing nebulizer treatment. The trial will involve two groups: an intervention group engaging with play dough and picture books during treatment and a control group receiving standard care. Physiological data, including heart rate and oxygen saturation, will be monitored alongside behavioral assessments of anxiety and fear. This study seeks to determine whether these non-pharmacological interventions can alleviate distress in young children, contributing to more child-friendly treatment approaches in pediatric healthcare.

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Key information

Conditions

Nebulizer Therapy

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başkent University

Ankara, Beşevler, 60300, Turkey (Türkiye)

Location contact

Ayşe Ay, Asisst Prof

CONTACT

Nebahat Ayten, RN

CONTACT

İlçim Ercan Koyuncu, RN, MSc

CONTACT

[email protected]

05534700629

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being in the 3-6 age group
  • Follow-up in the emergency department with upper or lower respiratory tract disease
  • Application of nebuliser therapy
  • Staying with the parent during the research
  • To be able to speak and understand Turkish
  • Parents' consent to participate in the study

Exclusion criteria

  • Having a disease that causes maladaptive behaviours (ADHD, Autism, etc.)
  • Having a chronic disease affecting the respiratory tract
  • Chronic diseases or serious infections affecting vital signs
  • Implementation of droplet or contact isolation
  • Having a physical disability that will prevent him/her from playing with playdough
  • Having a cognitive disability that prevents reading books

Treatment and study plan

Play dough

Other
  • Children and families will be informed about the purpose of the study and their verbal and written consent will be obtained.
  • The first part of the Patient Information Form will be completed for children who accept the study.
  • The second part of the Patient Information Form will be completed five minutes before nebulizer treatment.
  • Five minutes before nebulizer treatment, play dough will be given to the child.
  • The child will be allowed to play with the play dough during the nebulizer treatment.
  • The second part of the Patient Information Form will be filled in at the 5th minute of the treatment and after the treatment is over.
  • The application will take approximately 15 minutes.

picture book reading

Other
  • Children and families will be informed about the purpose of the study and their verbal and written consent will be obtained.
  • The first part of the Patient Information Form will be completed for children who accept the study.
  • The second part of the Patient Information Form will be completed five minutes before nebulizer treatment.
  • Five minutes before nebulizer treatment, the child will be given a picture book.
  • Picture book will be read to the child during the treatment.
  • The second part of the Patient Information Form will be filled in at the 5th minute of the treatment and after the treatment is over.
  • The application will take approximately 15 minutes.

Primary outcomes

  1. Fear

    Time frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment

    The scale was developed for the age group of 4-10 years and is used in studies up to 3 years of age. It consists of five facial expressions ranging from neutral (0 points: no anxiety) to frightened face (4 points: severe anxiety). The child is asked to mark the degree of fear by choosing the most appropriate facial expression. As the score obtained from the scale increases, the child's level of fear increases.

  2. Anxiety

    Time frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment

    The scale is in the form of a thermometer. The bottom part of the thermometer is labelled as 'Calm: Not tense or anxious (0 points)', and the top part is rated as "Very tense or anxious (10 points)". To assess the child's state of anxiety, the child is asked to mark how he/she feels 'right now' on the thermometer. As the score obtained from the scale increases, the anxiety level of the child increases.

Secondary outcomes

  1. Pulse Rate

    Time frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment

    Maintaining and normalizing pulse rate within normal range (75-115 per minute)

  2. Respiratory Rate

    Time frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment

    Maintaining and normalizing respiratory rate within normal range (20-25 per minute)

  3. Saturation rate

    Time frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment

    Maintaining and normalizing saturation rate within normal range (95-100%)

Study contacts

Contact information is provided by the study sponsor or research team.

İlçim Ercan Koyuncu, RN, MSc

CONTACT

[email protected]

+905534700629

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

The Impact of Play Dough and Picture Books on Physiological Parameters, Anxiety, and Fear in 3-6-Year-Old Children During Nebulizer Treatment: a Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 31, 2024
Registry last updated
Nov 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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