Evidence map›Paper›PMID 36609355›Full record

ArticleTrials2023

The CALM trial protocol: a randomised controlled trial of a guided self-help cognitive behavioural therapy intervention to reduce dental anxiety in children.

Zoe Marshman, Helen Rodd, Caroline Fairhurst, Jenny Porritt, Bhupinder Dawett, Peter Day, Nicola Innes, Christopher Vernazza, Tim Newton, Sarah Ronaldson and 6 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Zoe MarshmanSchool of Clinical Dentistry, University of Sheffield, Sheffield, UK. z.marshman@sheffield.ac.uk.ORCID http://orcid.org/0000-0003-0943-9637
Helen RoddSchool of Clinical Dentistry, University of Sheffield, Sheffield, UK.
Caroline FairhurstYork Trials Unit, Department of Health Sciences, University of York, York, UK.
Jenny PorrittCentre for Behavioural Science and Applied Psychology, Sheffield Hallam University, Sheffield, UK.
Bhupinder DawettSchool of Clinical Dentistry, University of Sheffield, Sheffield, UK.
Peter DayLeeds Dental Institute, University of Leeds, Leeds, UK.
Nicola InnesSchool of Dentistry, Cardiff University, Cardiff, UK.
Christopher VernazzaSchool of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.
Tim NewtonFaculty of Dentistry, Oral & Craniofacial Sciences, King's College London, London, UK.
Sarah RonaldsonYork Trials Unit, Department of Health Sciences, University of York, York, UK.
Liz CrossSchool of Clinical Dentistry, University of Sheffield, Sheffield, UK.
Jennie RossRichmond Dental Care, 427-429 Richmond Road, Sheffield, UK.
Sarah R BakerSchool of Clinical Dentistry, University of Sheffield, Sheffield, UK.
Catherine HewittYork Trials Unit, Department of Health Sciences, University of York, York, UK.
David TorgersonYork Trials Unit, Department of Health Sciences, University of York, York, UK.
Hannah AinsworthYork Trials Unit, Department of Health Sciences, University of York, York, UK.

Funding

Health Technology Assessment Programme NIHR131805
6 · The paper itself

Abstract

backgroundGlobally, around 13% of children experience dental anxiety (DA). This group of patients frequently miss dental appointments, have greater reliance on treatment under general anaesthesia (GA) and have poorer oral health-related quality of life (OHRQoL) than their non-dentally anxious peers. Recently, a low-intensity cognitive behavioural therapy (CBT)-based, self-help approach has been recommended for management of childhood anxiety disorders. A feasibility study conducted in secondary care found this guided self-help CBT resource reduced DA and a randomised controlled trial was recommended. The present study aims to establish the clinical and cost-effectiveness of a guided self-help CBT intervention to reduce DA in children attending primary dental care sites compared to usual care.

methodsThis 4-year randomised controlled trial will involve 600 children (aged 9-16 years) and their parent/carers in 30 UK primary dental care sites. At least two dental professionals will participate in each site. They will be assigned, using random allocation, to receive the CBT training and deliver the intervention or to deliver usual care. Children with DA attending these sites, in need of treatment, will be randomly allocated to be treated either by the intervention (CBT) or control (usual care) dental professional. Children will complete questionnaires relating to DA, OHRQoL and HRQoL before treatment, immediately after treatment completion and 12 months post-randomisation. Attendance, need for sedation/GA and costs of the two different approaches will be compared. The primary outcome, DA, will be measured using the Modified Child Dental Anxiety Scale. Scores will be compared between groups using a linear mixed model. DISCUSSION: Treating dentally anxious patients can be challenging and costly. Consequently, these children are frequently referred to specialist services for pharmacological interventions. Longer waiting times and greater travel distances may then compound existing healthcare inequalities. This research will investigate whether the intervention has the potential to reduce DA and improve oral health outcomes in children over their life-course, as well as upskilling primary dental healthcare professionals to better manage this patient group.

trial registrationThis clinical trial has been registered with an international registry and has been allocated an International Standard Randomised Controlled Trial Number (ISRCTN27579420).

Indexed as

Cognitive Behavioral TherapyQuality of LifeAnxiety DisordersChildCost-Benefit AnalysisDental AnxietyHumansRandomized Controlled Trials as TopicSurveys and QuestionnairesTreatment OutcomeChild dental anxietyCognitive behavioural therapy intervention, Behaviour managementPrimary dental careRandomised clinical trial

Identifiers

PMID36609355
PMCPMC9817252

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.