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

Not Applicable

Completed

• Conditions: Children with special needs while receiving dental treatment; Oral Health

• Registration Number: ISRCTN57204958
• Lead Sponsor: niversiti Teknologi MARA

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36291461/ (added 19/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-27
• Study Completion: 2022-06-09
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 chairPre-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 minutesTreatment: chosen treatment, either prophylaxis or caries removal (using slow-speed handpiece inside the oral cavity for 1-2 minutesPost Treatment: child remains lying on the dental chair without Exposure A or Exposure B which lasts 1-2 minutes