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Physiological changes of children with special needs in the application of a papoose board during dental treatment and their caregiver's acceptance

Physiological changes of children with special needs in the application of a papoose board during dental treatment and their caregiver's acceptance: a non-blinded randomized crossover trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57204958
Enrollment
90
Registered
2020-08-27
Start date
2020-10-01
Completion date
Unknown
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with special needs while receiving dental treatment Oral Health

Interventions

Participants will receive two treatments (exposures) sequentially over two periods and the order in which treatments received is randomised (known as the 2×2 or AB/BA design). Exposure A is basic beha

Sponsors

Universiti Teknologi MARA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Child: 1. All children with special needs aged 16 years old and below who are willing to sit in the dental chair without excessive physical persuasion 2. Children with special needs who will be subjected to either prophylaxis treatment (using a bristle brush with a slow speed handpiece) or simple composite restorative treatment (class I) (using a round burr with a slow handpiece for anterior/posterior teeth) 3. No previous history of Papoose board experience 4. No previous trauma to the fingers of the hand (to enable electrode use in that hand) Caregiver: Caregiver can read and understand the language of conduct (Bahasa Malaysia/English)

Exclusion criteria

Exclusion criteria: Child: 1. Medically compromised child with any kind of underlying heart disease that may affect the heart rate variability measurement 2. Child who requires any prophylaxis or restorative treatment in conjunction with the usage of local anaesthesia or inhalation sedation 3. Child who are taken any medication or caffeinated drink on the day of the treatment/intervention 4. Child with episode of asthma and seizure attack, or restrictions in circulation over the past 3 months Caregiver: 1. Caregiver cannot read and understand the language of conduct (Bahasa Malaysia/English) 2. Caregiver refuses to give consent for their child and themselves to participate in this study

Design outcomes

Primary

MeasureTime frame
Caregiver's acceptance, concern and consent measured using 5-point Likert's Scale questionnaire before and after the intervention

Secondary

MeasureTime frame
Physiological changes recorded by a designated Dental Surgery Assistant (DSA): child’s blood pressure, heart rate and SpO2 will be measured by using a Welch Allyn Connex® Vital Signs Monitor in four different phases: Baseline: child in the waiting room/surgery room sitting on a chair Pre-Treatment: child lying down on the dental chair and proposed BGT (Exposure A) or wrap in PB (Exposure B) will be applied for 1-2 minutes Treatment: chosen treatment, either prophylaxis or caries removal (using slow-speed handpiece inside the oral cavity for 1-2 minutes Post Treatment: child remains lying on the dental chair without Exposure A or Exposure B which lasts 1-2 minutes

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026