- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04636580
Parental Affect in Dental Procedures
The Effect of Parents' Presence and Their Anxieties on Children's Dental Anxiety During Dental Procedures: Controlled Clinical Trial
Background: To evaluate the effect of the anxiety of a parent accompanying a child on the child's anxiety during treatment.
Methods: Parents of 160 patients (4-8 years old) were divided into two groups anxious and non-anxious. Each groups had separated two randomized subgroups that with/without parents accompanied their children. At the first visit, participating children were examined while the behavior of the child during the examination was evaluated by a single pediatric dentist according to their heart rates measured by a portable pulse oximeter and the data were recorded (objective data).Forty-two children with a score of 1 and 4 on the Frankel Scale were excluded. After the parents were divided into two groups, anxious and non-anxious, the groups were equally divided randomly and the parents accompanied their children during the treatment.
Patients were recalled after one week for the treatment visit. Both groups were evaluated using the basic behavior technique. Compomer fillings were performed on children with infiltration anesthesia. The children's heart rates were measured by a portable pulse oximeter during treatment. Finally, the children were asked to express how they felt about the treatment by pointing out one of the faces on the Wong-Baker Faces Scale (subjective data). The children also rated the experience on the Frankel scale administered by the same operator.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Usak, Tacchino, 64200
- Tuğba YIGIT
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- mentally and physically healthy children with caries requiring anesthesia and no previous dental experience were selected for the study
Exclusion Criteria:
- children with a score of 1 and 4 on the Frankel Scale were excluded.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: anxious parent
Parents were divided into two groups anxious and non-anxious.
|
After the parents were divided into two groups, anxious and non-anxious, the groups were equally divided randomly and the parents accompanied their children during the treatment
|
|
Sperimentale: non-anxious parent
Parents were divided into two groups anxious and non-anxious.
|
After the parents were divided into two groups, anxious and non-anxious, the groups were equally divided randomly and the parents accompanied their children during the treatment
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
change in anxiety during the treatment according to the accompaniment of the anxious parent of the child
Lasso di tempo: An average of 6 months
|
The child's anxiety during examination was evaluated with a pulse oximeter.
The child's anxiety during examination was evaluated with a pulse oximeter.
|
An average of 6 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Esra OZGOCMEN, Dr., Uşak University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UsakU5
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .