The acceptability and effectiveness of a computer-based oral health intervention for children undergoing caries treatment under general anaesthesia

• Register: ISRCTN
• Last refreshed on: 6 April 2020
• Main ID: ISRCTN94617251
• Date of registration: 05/08/2014
• Prospective Registration: No
• Primary sponsor: King?s College London (UK)
• Public title: The acceptability and effectiveness of a computer-based oral health intervention for children undergoing caries treatment under general anaesthesia
• Scientific title: The acceptability and effectiveness of a computer-based oral health intervention for children undergoing caries treatment under general anaesthesia: A randomized controlled trial
• Date of first enrolment: 01/10/2013
• Target sample size: 128
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN94617251
• Study type: Interventional
• Study design: Single-centre randomized single-blind controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Marie Therese Hosey

Key inclusion & exclusion criteria

Inclusion criteria:
1. Scheduled for treatment of dental caries under general anaesthesia
2. Four to ten years old
3. Doesn't suffer from any learning difficulties or medical conditions complicating oral health status
4. An English speaker
5. Accompanied by a parent/guardian able to provide consent

Exclusion criteria:
1. Referred for treatment of other dental conditions.
2. Younger the four years or older than ten years.
3. Has a medical condition affecting oral health, or those with learning difficulties.
4. Doesn't speak English.
5. Accompanied by an adult that cannot give consent.
6. Parents/children that refuse to participate in the study.


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Prevention of dental caries
Oral Health

Intervention(s)

1. Intervention group (video game): receives oral health advice via a video game (delivered on an iPad), also receives fluoride varnish application.
2. Control group (verbal advice): receives oral health advice verbally from a trained dental nurse, also receives fluoride varnish application.

Both interventions (video game, verbal advice) will be applied only once, at the medical pre-assessment clinic prior to the child's general anaesthesia. A follow up appointment will be arranged for participants from both groups approximately three months after the surgery.

Primary Outcome(s)

1. Acceptability of intervention: Parent and child satisfaction with the intervention as indicated using a Visual Analogue Scale (VAS), where 0 is not satisfied at all and 10 is very satisfied.
2. Child dietary knowledge: Measured by a Child picture Food Quiz at three points: Baseline Immediately post-intervention, and 3 months later.
3. Child dietary practices reported by parents: using the 'children dietary questionnaire' (CDQ) at baseline and after 3 months.
4. Child reported snack selection: measured by snack diaries given after intervention and returned on the day of general anaesthesia procedure.
5. Child reported Tooth brushing frequency: measured by tooth brushing diaries given after intervention and returned on the day of general anaesthesia procedure.

Secondary Outcome(s)

Childs acceptability of fluoride varnish: indicated using a Visual Analogue Scale (VAS). where 0 is not satisfied at all and 10 is very satisfied.

Secondary ID(s)

N/A

Source(s) of Monetary Support

King's College London (UK)

Ethics review

Status:
Approval date:
Contact:

NRES Committee London - Dulwich; 05/08/2013; ref. 11/LO/0220

Results

• Results available: Yes
• Date Completed: 31/12/2014