The Ventriloquist Puppet Method for Children Under The Inhaler Treatment

NCT06162598 | Unknown

• 1 other identifier: KMU-SBF-TA-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to determine the effect of preparation with the ventriloquist puppet method before inhaler treatment on anxiety and fear level of children aged 4-6

Conditions

Hospitalism in Children

Keywords

Children; Nursing; Puppet; Ventriloquist; Inhaler treatment; Therapeutic approach

Outcome Measures

Primary Outcomes (2)

• Anxiety

  Children's State Anxiety Scale: Validated scale used for evaluation of 4-10 aged children's anxiety level. Scale score ranges between 0-10

  one day

• Fear

  Children's Fear Scale: Validated scale used for evaluation of 5-10 aged children's fear level. Scale score ranges between 0-4.

  one day

Study Arms (2)

Control Group

NO INTERVENTION

Children in the control group will undergo the routine preparation procedure applied in the emergency department. Before and after inhaler treatment, the child, parent, and nurse will be asked to fill out data collection forms to assess the child's anxiety and fear levels.

Ventriloquist Puppet group

EXPERIMENTAL

The preparation for the procedure will be accompanied by a puppet before the treatment. The child will be told about the features of the puppet and will be introduced to it. The inhaler treatment application will be explained to the intervention group through the ventriloquist puppet method. By making the puppet talk using the ventriloquism technique, the child will be able to understand the procedure. The application of the inhaler will be shown to the child with the help of a nebulizer mask on the puppet. Before the application and after the inhaler treatment, the child, parent, and nurse will be asked to fill out the children's state anxiety scale and children's fear scale to evaluate the child's anxiety and fear levels.

Other: Ventriloquist Puppet

Interventions

Ventriloquist Puppet OTHER

one day preparation intervention applied by researcher for children under the inhaler treatment. Preparation will be 30 minutes long

Ventriloquist Puppet group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 4-6,
• Children receiving inhaler therapy,
• Children and families who can speak Turkish,
• Children and families who volunteer to participate in the research,

You may not qualify if:

• Children with cognitive or mental problems,
• Children with life-threatening conditions,
• Children with hearing, vision and/or speech impairments

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (1)

Tuba ARPACI

Karaman, 70200, Turkey (Türkiye)

RECRUITING

Study Officials

• Tuba ARPACI, PhD

  Karamanoğlu Mehmetbey University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuba ARPACI, PhD

CONTACT

+905306401928; tubaarpaci25@gmail.com

Merve Akar

CONTACT

+905372945961; merveakar555@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant Professor

Model Details: Two group with conventional therapy control group

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: August 12, 2023
• Primary Completion: May 15, 2024
• Study Completion: July 15, 2024
• Last Updated: March 6, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)