- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07769788
The Effect of Multisensory Stimulation Administered Before Clinical Encounters at the Pediatric Surgery Outpatient Clinic on Children's Anxiety and Fear Levels and Parental Anxiety
The Effect of Multisensory Stimulation Administered Before Clinical Encounters at the Pediatric Surgery Outpatient Clinic on Children's Anxiety and Fear Levels and Parental Anxiety: A Randomized Controlled Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
In recent years, there has been an interest in non-pharmacological interventions to address anxiety and fear levels in pediatric healthcare. Methods such as distraction techniques, digital applications, game solutions, and multisensory stimulation have proven effective in children's health experiences. Multisensory stimulation, particularly with materials containing content targeting the senses of sight, hearing, smell, and touch, is a holistic, non-pharmacological approach that helps reduce developmental stage problems, behavioral issues, pain, fear, and anxiety in children. In its basic mechanism, multisensory stimulation activates tactile, thermal, and emotional systems, providing multiple stimuli and diverting children's attention away from the stressor through simultaneous auditory stimuli. The resulting sensory integration and attention redirection effect can contribute to the improvement of anxiety and fear levels. Among multisensory stimulation applications are: Mother-baby communication, skin-to-skin contact, breastfeeding which activates sensory receptors and taste in the skin, the use of amniotic fluid or aromatic scents are included. In addition, practices such as making eye contact with the baby, speaking in a soft tone of voice, massaging, coordinating and using parental credit are among the components of multisensory stimulation. However, it is noted that this is largely focused on childbirth and that the clinical limits are restricted.
There is limited scientific evidence in the literature that multisensory stimulation may be effective in reducing pain and fear, especially after surgical procedures, in the days of birth. It is observed that the current centers, with multiple voice alerts, are quite limited in addressing the anxiety and fear at home before clinical encounters in pediatric surgery outpatient clinics, where most neonatal or pre-operative processes are evaluated, and the situational anxiety of individuals is addressed together with outbreaks. However, the outpatient setting has critical relationships as the first point of contact with the modern health system, and the anxiety, fear, and parental anxiety experienced at this stage significantly affect the child's subsequent health experiences and compliance with health services. Therefore, the emergence of effective, short-term, and non-pharmacological interventions in the pre-clinical encounter period will be of great importance. In line with this, these randomized controlled trials are planned to examine the effect of multiple sensory stimuli on the situational anxiety of individuals in pediatric surgery outpatient clinics, prior to clinical encounters, and in terms of anxiety and fear. The study results will contribute to supporting a low-level, effective, and effective intervention in pediatric surgery outpatient clinics. Furthermore, it will lay the groundwork for demonstrable practices that will strengthen this developmental, child and family-centered care approach and contribute to the widespread use of psychosocial support practices in pediatric health services.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Fulya Merve FMK KOS, Assis Prof Dr
- Numéro de téléphone: 05300974816
- E-mail: fulya.kos@bilecik.edu.tr
Lieux d'étude
-
-
Turkey
-
Bilecik, Turkey, Turquie (Türkiye), 11230
- Bilecik Seyh Edebali University
-
Contact:
- Fulya KOS
- Numéro de téléphone: 05300974816
- E-mail: fulya.kos@bilecik.edu.tr
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- For the children to be sampled, the inclusion criteria plan to involve children who:
- Are aged between 5 and 10 years,
- Are undergoing their first outpatient pediatric surgery evaluation,
- Have no prior history of surgery, and Agree (along with their parents) to voluntarily participate in the study.
Exclusion Criteria:
- For the children to be sampled, the exclusion criteria plan to omit children who:
- Are in unstable general condition or require emergency medical intervention,
- Have intellectual disabilities, or Have visual or hearing impairments.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: The Effect of Multisensory Stimulation on Pain and Anxiety in Children with Pediatric Surgery
|
Stimulation multisensorielle
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Children's Pre-procedural Anxiety Level
Délai: (Baseline / Pre-encounter
|
Children's Anxiety Scale - State Scale The CAS-S resembles a thermometer featuring a bulb at the bottom and horizontal lines spaced at intervals as they rise upwards.
Designed for children aged four to ten, this scale instructs children to "Imagine that all your anxious or nervous feelings are in the bulb or lower part of the thermometer."
"If you feel a little anxious or tense, your feelings may rise a little higher on the thermometer.
"Put a line on the thermometer to show how anxious or nervous you are."
It was discovered during the researchers' data collection process that some children were familiar with the typical mercury thermometer represented on the scale, and when children did not understand this analogy, they used an alternative scenario that did not explicitly describe a thermometer.
Children are told, "Think of all the anxious or nervous feelings as being at the bottom here (point with your finger on the scale).
|
(Baseline / Pre-encounter
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Children's Fear Level
Délai: Baseline / Pre-encounter
|
The Child Fear Scale (CFS), validated and proven reliable by Gerçeker et al. (2018), is used to measure a child's anxiety level.
The CFS is a scale that evaluates children's anxiety levels using a 0-4 rating system, consisting of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety).
It can be used by families and researchers to assess pre-procedural and intra-procedural pain and anxiety in children and is aimed at children aged 5-10 years.
The CFS is based on the Faces Anxiety Scale developed by McKinley et al. (2003) to measure the fear or anxiety of adults in the intensive care unit.
It is a scale consisting of one item and five gender-neutral faces.
The facial muscle changes in the fearful expressions were drawn by a graphic artist based on photographs of frightened faces.
The scale will be administered to children as a pre-test and post-test.
|
Baseline / Pre-encounter
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Parental State Anxiety Level
Délai: Baseline / Pre-encounter
|
State-Trait Anxiety Inventory A 10-item short version of the 40-item State-Trait Anxiety Inventory (STAI) was developed by Zsido et al. In the process of shortening the STAI, Zsido et al. (2020) first removed the reverse-scored items from the scale and then reduced these inventories to their short 5-item forms (STAIS-5 and STAIT-5) by performing confirmatory factor analysis (CFA), item response theory analysis, and ROC analysis to preserve the best discriminating items. The 4-point Likert-type scales consist of 5 items. The emotions and behaviors indicated in STAIS-5 are marked according to their degree of severity as 1 = None, 2 = Somewhat, 3 = Moderately, 4 = Very much; and the STAIT-5 items are marked as 1 = None, 2 = Sometimes, 3 = Moderately, 4 = Very much. Individuals scoring 10 or higher on STAIS-5 and 14 or higher on STAIT-5 are considered clinically anxious. The Cronbach's alpha values for STAIS-5 and STAIT-5 were calculated as 0.86 and 0.91. |
Baseline / Pre-encounter
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- No publications resulting from this study are available at this time as the trial is currently ongoing.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Bilecik-BSEU3
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Individual Participant Data (IPD) will not be made publicly available or shared for this study due to ethical considerations regarding participant confidentiality and the explicit terms of the informed consent protocol.
Specifically:
Informed Consent Constraints: The informed consent forms approved by the Institutional Review Board (IRB) / Ethics Committee and signed by the parents/guardians do not include permissions for raw, individual-level data sharing with external third parties or public repositories.
Privacy and Vulnerability: Given that the study population consists of pediatric patients undergoing clinical evaluations, raw IPD contains sensitive demographic and clinical details that could potentially compromise participant anonymity.
De-identified aggregate statistical data, protocol details, and final study findings will be made available through published peer-reviewed journal articles and clinical trial registries upon study completion.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .