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NCT Number: NCT07585448

Effectiveness of Audio-Tactile Performance Technique With Sing-Along Lyrics on Oral Hygiene Instruction to Visually Impaired Individuals

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.

1. 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? 2. 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.

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Key information

Conditions

Oral Hygiene Visually Impaired Persons

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory boarding Secondary school, Ki̇̄rtipur, Kathmandu, Nepal

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATP

Procedure

ATP with standard audio file

ATP with song

Behavioral

ATP with informational song used to provide guidance to the participants

Primary outcomes

  1. 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:

    • Maintaining a 45-degree angle of the bristles.
    • Using an appropriate back-and-forth vibrating motion.
    • Ensuring adequate surface coverage.
    • Brushing for at least 5 seconds per surface.

    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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Effectiveness of Audio-Tactile Performance Technique With Sing-Along Lyrics on Oral Hygiene Instruction to Visually Impaired Individuals: A Matched-Pair Randomized Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 13, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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