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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07585448
Effectiveness of Audio-Tactile Performance Technique With Sing-Along Lyrics on Oral Hygiene Instruction to Visually Impaired Individuals: A Matched-Pair Randomized Study
The goal of this match-pair randomized study is to compare the effectiveness of the standard Audio-Tactile Performance (ATP) technique with a song-based adaptation (ATP/S) in teaching oral hygiene in visually impaired individuals aged 6 to 20 years in Kathmandu, Nepal.
- Can the ATP/S approach achieve a greater improvement in plaque control, as measured by the Patient Hygiene Performance (PHP) index, compared to standard ATP instruction over a two-week period?
- Does the rhythmic structure of a song lead to a more continuous improvement in toothbrushing task performance and theoretical oral health knowledge?
Researchers will compare a control group receiving standard ATP with an audio information file to an intervention group receiving ATP with a sing-along song to see if rhythmic auditory stimuli help regulate sequencing and reduce working-memory demands during complex motor tasks.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is divided in to 2 groups where visually impaired individuals are allocated after inclusion and exlusion criteria.
In this matched-pair randomized study, 40 VI participants aged 6-20 years were allocated to ATP or ATP/S groups. Outcomes were assessed at baseline, immediately post-intervention, and at two-week follow-up using the Patient Hygiene Performance (PHP) index, a 16-step toothbrushing task analysis, and an eight-item oral health knowledge questionnaire. Intra-group changes were analyzed using the Friedman test; inter-group comparisons used the Mann-Whitney U test (p < 0.05).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kathmandu
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Ki̇̄rtipur, Kathmandu, Nepal, 44600
- Laboratory boarding Secondary school
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Lagankhel
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Lalitpur, Lagankhel, Nepal, 44600
- Namuna Macchindra secondary school
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Bilateral visually impaired in age 6-20yrs. (as verified in school medical record)
Exclusion Criteria:
- Visual impairment associated with any disabilities that affected arm motor skill/loss of upper dexterous extremity/abnormal mental development/deaf.
- Using any chemical plaque control agent.
- Individuals with calculus on examining teeth
- On medications that could affect the gingival status.
- Inability to brush due to pain from severe caries/oro-mucosal conditions.
- Have less than 4 teeth in each quadrant.
- Presented with orthodontic or prosthodontic appliance.
- Subject with good oral hygiene ; plaque score = 0
- Un co-operative children.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: ATP with audio information file
Participants in this arm receive Oral Hygiene Instruction (OHI) using the standard Audio-Tactile Performance (ATP) technique.
This involves hands-on training with a tooth model (dentoform) paired with a pre-recorded audio information file that provides verbal instructions on brushing techniques.
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ATP with standard audio file
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Experimental: ATP with informational song
Group B (Intervention Group): Participants in this arm receive OHI using the ATP technique enhanced with a sing-along song.
This method utilizes the same hands-on training with a tooth model but replaces the standard audio file with a culturally adapted song containing the brushing instructions, leveraging rhythmic entrainment to aid memory and coordination.
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ATP with informational song used to provide guidance to the participants
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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tooth brushing task analysis
Periodo de tiempo: from baseline to intervention, reinforment (1 week) & Final data collection (end of 2 weeks)
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The oral cavity is divided into 16 surface areas. Scoring Criteria: For each area, participants are scored on four specific criteria:
Calculation: Each correctly executed criterion earns 1 point, and the total skill level is determined by the percentage of points achieved out of the total possible points. |
from baseline to intervention, reinforment (1 week) & Final data collection (end of 2 weeks)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient hygiene performance (PHP score)
Periodo de tiempo: from baseline to intervention, reinforment (1 week) & Final data collection (end of 2 weeks)
|
The secondary outcome evaluates the objective effectiveness of the brushing by measuring the amount of dental plaque (debris) left on the teeth. The Process: Teeth are stained with erythrosin dye, which highlights plaque. Scoring Method: Six specific index teeth are examined, with each tooth surface divided into five sections. Binary System: A section receives a 1 if debris is present and a 0 if it is absent. Calculation: The final PHP score is the sum of these points divided by the number of surfaces examined; a lower score indicates better oral hygiene. |
from baseline to intervention, reinforment (1 week) & Final data collection (end of 2 weeks)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Oral Health Knowledge Questionnaire
Periodo de tiempo: from baseline, intervention, reinforcement (1 week) and final data collection (end of 2 week)
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A pre-test and post-test consisting of 8 questions are administered verbally to accommodate visual impairment. 8 questions are asked based on the audio information and song file Correct answers are recorded to track how well the instructional formats (standard audio vs. song) reinforce theoretical knowledge over time |
from baseline, intervention, reinforcement (1 week) and final data collection (end of 2 week)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: woranun Prapansilp, Masters pediatric dentistry, Mahidol University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 61_2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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