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Prevalance of Intraoral Injection Fear

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04335500
Recruitment Status : Not yet recruiting
First Posted : April 6, 2020
Last Update Posted : May 4, 2020
Information provided by (Responsible Party):
Nora Mohamed Mosaad Hussien, Cairo University

Brief Summary:

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.

Condition or disease
Injection Fear, Fear, Avoidance, Dental

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)

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Study Type : Observational
Estimated Enrollment : 184 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: 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
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Prevalence of dental fear [ Time Frame: immediate ]
    children fear survey subscale

Other Outcome Measures:
  1. Dental avoidance [ Time Frame: immediate ]
    single question

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children from 8 to 10 years with or without previous dental experience

Inclusion Criteria:

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

Exclusion Criteria:

  • Medically compromised children. Refusal of participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04335500

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Contact: Nora Mosaad, Bachelor degree 01000921189

Sponsors and Collaborators
Cairo University
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Study Chair: Pediatric dentistry department Faculty of oral and dental medicine
Publications of Results:
Other Publications:
Marshman, Z., Noble, F., Rodd, H., 2018. 'Your teeth you are in control.' Dental Nursing 14, 292-293. doi:10.12968/denn.2018.14.6.292
Mednick, L.M., Claar, R.L., 2012. Treatment of severe blood-injection-injury phobia with the applied-tension method: Two adolescent case examples. Clinical Case Studies. doi:10.1177/1534650112437405

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Responsible Party: Nora Mohamed Mosaad Hussien, Principle investigator, Resident at pediatric dentistry department Nora Mohamed Mosaad, Cairo University Identifier: NCT04335500    
Other Study ID Numbers: Inraoral injection fear
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No