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- Essai clinique NCT04775771
The Effect of Animal-assisted Practice Applied to Hospitalised Children on Children's Anxiety, Fear, Psychological and Emotional Well-being
29 mars 2022 mis à jour par: Abdullah Sarman, Inonu University
The Effect of Animal-assisted Practice Applied to Hospitalised Children on Children's
In the normal development stage, children become ill for various reasons and maybe hospitalised.
Illnesses and hospitalization are major sources of stress for any growing child.
In addition to being admitted to the hospital, unknown environment, unknown people in this environment, unknown equipment, scary voices, thought of physical harm, fears such as separation from the family, etc. Different degrees of stress occur for reasons.
In addition to these, children face many problems related to physical limitations caused by hospitalization due to illness, and they experience negative emotions such as anxiety, fear, and anxiety.
On the day the child is admitted to the hospital, the child and his family experience high levels of anxiety.
Children's anxiety and fear may negatively affect their ability to understand the explanations to be made correctly, to interpret events realistically, to make appropriate decisions, and to participate in care.
Various treatment methods such as therapeutic games, art therapy, drawing, occupational therapy, animal-assisted practices/activities (HDU) are applied in the hospital environment to improve the child's coping skills and to reduce negative emotions such as pain, anxiety, stress, and fear.
The animal-assisted practice is activities that offer various opportunities to improve the quality of life and provide entertainment and therapeutic benefits.
Although the use of animal-assisted applications is widespread abroad, its use in our country and the rate of reflection on the results of the study is quite limited.
In the researches, interaction with such animals; has been determined to be psychologically, emotionally, socially, and physically supportive in children.
It is planned to use goldfish in this study.
Aquarium fish is one of the ornamental fish sold in more than 125 countries and more than 2500 species globally.
No study has been conducted on the effects of aquarium fish, which are reported to have positive effects and provide calming when applied with adult age groups within the scope of animal-assisted practices, on anxiety, fear, psychological and emotional well-being in children treated in a clinical setting.
This study will be conducted to examine the effects of animal-assisted practice on anxiety, fear, the psychological and emotional well-being of children hospitalised.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
112
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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Bingöl, Turquie, 12000
- Bingöl Obstetrics and Pediatrics Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
8 ans à 10 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Being 8 years old and over, 10 years old or younger,
- Hospitalization due to an acute illness,
- Not afraid of aquarium fish to be used in practice,
- Not being allergic to fish and fish food,
- Not having physical, auditory, visual, and cognitive disabilities that would prevent the aquarium fish from feeding twice daily and in the aquarium within the scope of HDU,
- Staying in the pediatric clinic for three days,
- Not having a speech disorder that will prevent them from communicating.
Exclusion Criteria:
- Having a physical, auditory, visual, and cognitive disability that prevents the aquarium fish from feeding twice daily,
- Afraid of goldfish,
- Being allergic to fish and eating.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Animal Assisted Practice (Experimental) Group
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The children, who were planned to be hospitalized for at least three days and were randomized to the experimental and control groups, were asked by the researcher using the face-to-face interview technique, and the questions in the patient information form were filled in on the form.
Then, pre-test data were recorded by determining their anxiety levels with the State Anxiety Scale for Children, levels of fear with the Child Fear Scale, emotional and psychological well-being with the Stirling Children's Emotional and Psychological Well-being Scale.
Unlike the other scales, the anxiety levels were assessed twice with one-hour intervals on the first day with the Children's State Anxiety Scale.
On the third day, the anxiety levels were evaluated twice with one-hour intervals on the first day using the State Anxiety Scale for Children.
The second group, the children in the control group, had the same procedure except for the intervention; but no intervention was made.
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Aucune intervention: Groupe de contrôle
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The mean of STAI-1
Délai: Ten months
|
The State Anxiety Inventory for Children (STAI-1): It consists of 20 items scored from 1 to 3 according to the severity and the scores to be obtained from the scale data range between 20 and 60.
The Cronbach-Alpha value of the scale was found to be 0.82.
Although the validity and reliability study of the scale has been conducted on children aged 9-12, it is also used in children between the ages of 7-17.
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Ten months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The mean of CFS
Délai: Ten months
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The Child Fear Scale (CFS): It is a scale consisting of showing five drawn facial expressions ranging from neutral expression (0 points) to "no fear", to a frightened face (4 points) "severe fear".
The scale is intended for children aged 5-10 years.
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Ten months
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The mean of SCWBS
Délai: Ten months
|
Stirling Children's Emotional and Psychological Well-being Scale (SCWBS): It is a scale developed to measure the emotional and psychological well-being levels of children between the ages of 8-15 and is graded between "never" (1 point) and "always" (5 points), consisting of 12 question items, in accordance with the 5-point Likert model.
There is no reverse item on the scale.
High scores from the scale indicate a high level of emotional and psychological well-being for children.
Item-total correlation coefficients of the scale were ranked between 0.57-0.73; the Cronbach-Alpha internal consistency coefficient was calculated as 0.90.
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Ten months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 novembre 2020
Achèvement primaire (Réel)
31 août 2021
Achèvement de l'étude (Réel)
31 août 2021
Dates d'inscription aux études
Première soumission
25 février 2021
Première soumission répondant aux critères de contrôle qualité
25 février 2021
Première publication (Réel)
1 mars 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 mars 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 mars 2022
Dernière vérification
1 mars 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2020/1166
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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