- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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
|
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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.
|
ATP with informational song used to provide guidance to the participants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tooth brushing task analysis
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient hygiene performance (PHP score)
Time Frame: 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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral Health Knowledge Questionnaire
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: woranun Prapansilp, Masters pediatric dentistry, Mahidol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 61_2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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