Prevalance of Intraoral Injection Fear

May 1, 2020 updated by: Nora Mohamed Mosaad Hussien, Cairo University

Self-reported Fear of Intraoral Injections and Its Relationship to Dental Fear and Subsequent Avoidance of Dental Treatment Among 8 to 10 Years Children: Across Sectional Study

Aim of the study

  1. Estimate the prevalence of intraoral injection fear and its relationship to dental fear among 8-10 years children.
  2. Explore the possible consequences of such problems in terms of avoidance of dental and medical care.

Study Overview

Status

Unknown

Conditions

Detailed Description

Statement of the problem Despite all the technological advancements in the dental profession, fear toward dentistry remains a major concern and potentially distressing problem in daily practice (Oliveira et al. 2014).

Dental fear is a normal emotional reaction to one or more specific threatening stimuli within the dental situation and Intra oral injection is considered one of the most fear-provoking stimuli in the dental setting. Excessive or unreasonable fear or anxiety can influence daily living and result in prolonged avoidance of dental treatment leading to a public health dilemma (Shim et al. 2015).

People with high dental fear, children and adults, may prove difficult to treat, require more time, and present with behavioral problems which can result in a stressful and unpleasant experience for both the patient and treating dental practitioner (Armfield & Heaton 2013).

Rationale Intra-oral injections have been shown to be among the most fear-provoking stimuli in the dental setting.(Berge et al. 2016) Dental patients with fear and anxiety may also become dependent on pharmacological approaches for the management of their care, particularly if they do not receive treatment for their anxiety (MCGoldrick et al. 2001).

Assessment of high intra-oral injection fear is of paramount impact in offering the affected patients appropriate treatment , such as cognitive behavioral therapy and applied tension. (Berge et al. 2016) Cognitive Behavioral Therapy (CBT) is a goal-orientated talking therapy which aims to help people manage their problems by changing how they think and behave in relation to their problems. CBT incorporates a variety of different cognitive and behavioral strategies which aim to help the patient modify the unhelpful behaviors or thoughts maintaining their anxiety. (Marshman et al. 2018) Applied tension is a treatment method that is used with patients with blood-injection-injury phobia to alter their physiological response to the feared stimulus. The method includes repeated muscle tensing when in the presence of feared stimuli to counteract the drop in blood pressure and prevent vasovagal syncope.(Mednick et al. 2012) During Dental Procedures Some children may experience vasovagal syncope, proper history taking from those patients will help the dentist get prepared for such a probability.(Vika et al. 2008) Some adjusted behavior management techniques are used in order to prevent fainting, for example, applied tension (Vika et al. 2008)

Study Type

Observational

Enrollment (Anticipated)

184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 10 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children from 8 to 10 years with or without previous dental experience

Description

Inclusion Criteria:

  • : school aged children (8 to10) years old. With or without previous dental experience

Exclusion Criteria:

  • Medically compromised children. Refusal of participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of intraoral injection fear
Time Frame: immediate
self reported fear of intraoral injection through filling of a 12 questions of Intraoral Injection Fear scale, the scale has scores from 12 to 60 and the cut off score is 38, Below 38 is better as it means the child is not fearful from intraoral injections.
immediate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of dental fear
Time Frame: immediate
children fear survey subscale
immediate

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental avoidance
Time Frame: immediate
single question
immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Pediatric dentistry department, Faculty of Oral and Dental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (ACTUAL)

April 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2020

Last Update Submitted That Met QC Criteria

May 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Inraoral injection fear

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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