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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Play Dough Group | Experimental | The child will be provided with play dough five minutes before the commencement of nebulizer treatment and will be allowed to continue playing with it throughout the treatment. |
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| Picture Book Reading group | Experimental | Five minutes before the commencement of nebulizer treatment, the child will be provided with a picture book and will be allowed to continue reading it throughout the treatment. |
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| Control Group | No Intervention | Nebulizer treatment of the child will be performed by the routine protocols currently applied in the emergency department. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| play dough | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Fear | 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. | 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment |
| Anxiety | 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. | 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Rate | Maintaining and normalizing pulse rate within normal range (75-115 per minute) | 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment |
| Respiratory Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| İlçim Ercan Koyuncu, RN, MSc | Contact | +905534700629 | ilcimercan@baskent.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Başkent University | Ankara | Beşevler | 60300 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25012949 | Background | Goralski JL, Davis SD. Breathing easier: addressing the challenges of aerosolizing medications to infants and preschoolers. Respir Med. 2014 Aug;108(8):1069-74. doi: 10.1016/j.rmed.2014.06.004. Epub 2014 Jun 25. | |
| 16899849 | Background | Esposito-Festen J, Ijsselstijn H, Hop W, van Vliet F, de Jongste J, Tiddens H. Aerosol therapy by pressured metered-dose inhaler-spacer in sleeping young children: to do or not to do? Chest. 2006 Aug;130(2):487-92. doi: 10.1378/chest.130.2.487. |
| Label | URL |
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| Related Info | View source |
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| picture book reading | Other |
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Maintaining and normalizing respiratory rate within normal range (20-25 per minute)
| 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment |
| Saturation rate | Maintaining and normalizing saturation rate within normal range (95-100%) | 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment |
| 17411409 | Background | Erzinger S, Schueepp KG, Brooks-Wildhaber J, Devadason SG, Wildhaber JH. Facemasks and aerosol delivery in vivo. J Aerosol Med. 2007;20 Suppl 1:S78-83; discussion S83-4. doi: 10.1089/jam.2007.0572. |
| 26070582 | Background | DiBlasi RM. Clinical Controversies in Aerosol Therapy for Infants and Children. Respir Care. 2015 Jun;60(6):894-914; discussion 914-6. doi: 10.4187/respcare.04137. |
| 30651182 | Background | Supat B, Brennan JJ, Vilke GM, Ishimine P, Hsia RY, Castillo EM. Characterizing pediatric high frequency users of California emergency departments. Am J Emerg Med. 2019 Sep;37(9):1699-1704. doi: 10.1016/j.ajem.2018.12.015. Epub 2018 Dec 12. |
| 33742204 | Background | Durak H, Uysal G. The Effect of Cartoon Watching and Distraction Card on Physiologic Parameters and Fear Levels During Inhalation Therapy in Children: A Randomized Controlled Study. J Trop Pediatr. 2021 Jan 29;67(1):fmab018. doi: 10.1093/tropej/fmab018. |
| Related Info | View source |
| Related Info | View source |