- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07913191
Effect of Nurse-Directed Therapeutic Positioning in Children With Pneumonia
Effectiveness of Nurse- Directed Therapeutic Positioning on Vital Signs, Oxygen Saturation, and Respiratory Distress Severity Among Children With Pneumonia: A Comparative Study
Pneumonia is a common respiratory infection in children that may cause respiratory distress and impaired oxygenation. This quasi-experimental study aims to evaluate the effectiveness of nurse-directed therapeutic positioning on vital signs, oxygen saturation, and respiratory distress severity among children aged 3-5 years diagnosed with pneumonia. The study will compare two therapeutic positioning interventions, side-lying position and semi-Fowler's position, with a control group receiving routine nursing care. The outcomes will be assessed to determine the effects of these positioning interventions on the respiratory status of children with pneumonia.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nidaa H Mardan
- Numéro de téléphone: +9647807779284
- E-mail: nedaa.hazem2504m@conursing.uobaghdad.edu.iq
Sauvegarde des contacts de l'étude
- Nom: Adraa H Shawq, Phd
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Children aged 3-5 years.
- Children diagnosed with pneumonia.
- Children admitted to the selected pediatric hospitals.
- Children whose parents/guardians provide informed consent.
Exclusion Criteria:
- Children with chronic respiratory diseases.
- Children with congenital heart disease.
- Children with neuromuscular disorders.
- Children requiring mechanical ventilation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Side - Lying position Group
Children aged 3-5 years diagnosed with pneumonia will receive nurse-directed therapeutic positioning in the side-lying position. Vital signs, oxygen saturation, and respiratory distress severity will be assessed according to the study protocol. |
Nurse-directed therapeutic positioning will be implemented for children aged 3-5 years diagnosed with pneumonia. Children assigned to this group will be placed in the side-lying position under nursing supervision, with attention to comfort, safety, and clinical tolerance. The selected side, duration of each positioning session, frequency of application, and total intervention period will be specified in the study protocol. Vital signs, oxygen saturation, and respiratory distress severity will be assessed according to the study's measurement schedule to evaluate changes following the intervention. |
|
Expérimental: Semi - Fowler's Position Group
Children aged 3-5 years diagnosed with pneumonia will receive nurse-directed therapeutic positioning in the semi-Fowler's position. Vital signs, oxygen saturation, and respiratory distress severity will be assessed according to the study protocol. |
Nurse-directed therapeutic positioning will be implemented for children aged 3-5 years diagnosed with pneumonia. Children assigned to this group will be positioned in the semi-Fowler's position, with the head and upper body elevated according to the study protocol. Nursing supervision will be provided to maintain the child's comfort and safety and to monitor clinical tolerance. The elevation angle, duration of each positioning session, frequency of application, and total intervention period will be specified in the study protocol. Vital signs, oxygen saturation, and respiratory distress severity will be assessed according to the study's measurement schedule to evaluate changes following the intervention. |
|
Aucune intervention: Control Group
Children aged 3-5 years diagnosed with pneumonia will receive routine nursing care according to the hospital's standard practice. Vital signs, oxygen saturation, and respiratory distress severity will be assessed according to the study protocol. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Respiratory Rate
Délai: At baseline (before the application of the assigned therapeutic positioning method); and immediately after completion of the intervention.
|
Respiratory rate will be measured in breaths per minute and compared among the semi-Fowler, side-lying, and control groups. |
At baseline (before the application of the assigned therapeutic positioning method); and immediately after completion of the intervention.
|
|
Change in Respiratory Distress Severity
Délai: At baseline (before the application of the assigned therapeutic positioning method); and immediately after completion of the intervention.
|
Respiratory distress severity will be assessed using the Clinical Respiratory Score (CRS), which consists of six parameters: respiratory rate, auscultation, use of accessory muscles, mental status, room air oxygen saturation, and skin color. Each parameter is scored from 0 to 2, yielding a total score ranging from 0 to 12. Higher scores indicate greater respiratory distress. Change in respiratory distress severity will be compared among the semi-Fowler, side-lying, and control groups. |
At baseline (before the application of the assigned therapeutic positioning method); and immediately after completion of the intervention.
|
|
Change in Peripheral Oxygen Saturation (SpO₂)
Délai: At baseline (before the application of the assigned therapeutic positioning method); and immediately after completion of the intervention.
|
Peripheral oxygen saturation will be measured using a pulse oximeter and compared among the semi-Fowler, side-lying, and control groups. |
At baseline (before the application of the assigned therapeutic positioning method); and immediately after completion of the intervention.
|
|
Change in Heart Rate
Délai: At baseline (before the application of the assigned therapeutic positioning method); and immediately after completion of the intervention.
|
Heart rate will be measured in beats per minute and compared among the semi-Fowler, side-lying, and control groups. |
At baseline (before the application of the assigned therapeutic positioning method); and immediately after completion of the intervention.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Adraa H Shawq, Phd, University of Baghdad, College of Nursing
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
- NUR-TP-PNEU
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 will not be shared with other researchers. Data confidentiality will be maintained, and study findings will be reported in aggregate form without identifying individual participants.
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 .