- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07585448
Effectiveness of Audio-Tactile Performance Technique With Sing-Along Lyrics on Oral Hygiene Instruction to Visually Impaired Individuals
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Kathmandu
-
Ki̇̄rtipur, Kathmandu, Nepal, 44600
- Laboratory boarding Secondary school
-
-
Lagankhel
-
Lalitpur, Lagankhel, Nepal, 44600
- Namuna Macchindra secondary school
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
ATP with standard audio file
|
|
Experimentell: 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.
|
ATP with informational song used to provide guidance to the participants
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
tooth brushing task analysis
Tidsram: from baseline to intervention, reinforment (1 week) & Final data collection (end of 2 weeks)
|
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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient hygiene performance (PHP score)
Tidsram: 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)
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Oral Health Knowledge Questionnaire
Tidsram: from baseline, intervention, reinforcement (1 week) and final data collection (end of 2 week)
|
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)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: woranun Prapansilp, Masters pediatric dentistry, Mahidol university
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 61_2025
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .