The Ventriloquist Puppet Method for Children Under The Inhaler Treatment

March 5, 2024 updated by: Tuba Arpacı, Karamanoğlu Mehmetbey University

The Effect of Preparation With The Ventriloquist Puppet Method Before Inhaler Treatment on Anxiety and Fear Level of Children Aged 4-6

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Although treatment methods appropriate to the disease are applied in respiratory system diseases, healthcare professionals must cooperate with the child and family regarding compliance with the treatment (oral, nebulizer, inhaler) and management of the disease. Children may experience anxiety and fear from the moment they enter the hospital. They may react to being in the hospital and medical procedures such as crying, running away, or withdrawing. Age, previous negative hospitalization experiences, and fear of getting sick are factors that shape children's medical fears. The majority of children have 'a little' or 'a lot' of fear about medical procedures. Children have adaptation problems to the inhaler treatment and often reject it. To provide effective treatment, compliance of the child and family with the treatment and suitable application techniques are crucial. In this process, it is important to minimize the anxiety and fear of children and ensure that they receive the treatment in the best possible way. Therapeutic approaches such as distraction cards, musical toys, and puppets during the preparation of the child for the procedure before the treatment can increase the child's compliance with the treatment and reduce the level of anxiety. In a study, puppet shows were useful in reducing the fears of children with 'a lot' fear. In another study, finger puppets as a play enhanced communication with children with cancer and were suitable for use in the hospital environment. It has been concluded that the use of puppets is beneficial because it gives children the opportunity to express themselves freely. An effort should be made to reduce the child's anxiety and fear by taking a therapeutic approach not only for invasive procedures but also for non-invasive procedures. Therapeutic approaches can be applied to the child and family before, during, and after treatment. This study aimed to determine the effect of preparation with the ventriloquist puppet method before inhaler treatment on the anxiety and fear levels of children aged 4-6.

Study Type

Interventional

Enrollment (Estimated)

80

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 Contact

Study Contact Backup

Study Locations

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:

  • 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,

Exclusion Criteria:

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

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
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.
Experimental: Ventriloquist Puppet group
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
one day preparation intervention applied by researcher for children under the inhaler treatment. Preparation will be 30 minutes long

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear
Time Frame: one day
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
Anxiety
Time Frame: one day
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

Collaborators and Investigators

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

Sponsor

Karamanoğlu Mehmetbey University

Investigators

  • Principal Investigator: Tuba ARPACI, PhD, Karamanoglu Mehmetbey University

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)

August 12, 2023

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

July 15, 2024

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KMU-SBF-TA-02

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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