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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06162598
Other study ID # KMU-SBF-TA-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 12, 2023
Est. completion date July 15, 2024

Study information

Verified date November 2023
Source Karamanoglu Mehmetbey University
Contact Tuba ARPACI, PhD
Phone +905306401928
Email tubaarpaci25@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date July 15, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers No
Gender All
Age group 4 Years to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Tuba ARPACI Karaman

Sponsors (1)

Lead Sponsor Collaborator
Karamanoglu Mehmetbey University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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