Anxiety Clinical Trial
Official title:
The Effect of Therapeutic Play Applied by Using Toy Nebulizer and Toy Mask on Child's Fear and Anxiety Level
NCT number | NCT05415566 |
Other study ID # | 21116 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 8, 2021 |
Est. completion date | June 3, 2022 |
Verified date | June 2022 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, it was aimed to examine the effect of therapeutic play applied with a toy nebulizer and toy mask before inhaler treatment on children's fear and anxiety. It is the hypothesis of the study that the therapeutic play applied by using a toy mask and a toy nebulizer before inhaler treatment in children will reduce the child's fear and anxiety.
Status | Completed |
Enrollment | 84 |
Est. completion date | June 3, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 8 Years |
Eligibility | Inclusion Criteria: 1. Parent and child volunteering to participate in the study, 2. The child is between the ages of 3-8, 3. Being admitted due to respiratory system disease, 4. Inhaler treatment with a nebulizer will be applied. Exclusion Criteria: 1. Parent and child not voluntarily participating in the study, 2. Intravenous, intramuscular or any other treatment request, 3. The child has any genetic, congenital, chronic or metabolic disease, 4. The child has vision, hearing and speech problems, 5. The child's vital signs are unstable (no fever, tachypnea, etc.) and the need for any emergency intervention. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ege University | Izmir | Bornova |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reducing the child's fear | Reducing the child's fear during inhaler treatment | during inhaler treatment | |
Primary | Reducing the child's anxiety | Reducing the child's anxiety during inhaler treatment | during inhaler treatment | |
Secondary | Reducing the "Child Fear Scale" score | The Child Fear Scale (CFS) used. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. Scores range from 0 to 4. | shortly after inhaler treatment | |
Secondary | Reducing the "Child Anxiety Scale-Stateness" score | The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety. Scores range from 0 to 10. | shortly after inhaler treatment |
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