Prevalance of Intraoral Injection Fear

Injection Fear, Fear, Avoidance, Dental Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04335500
• Other study ID #: Inraoral injection fear
• Status: Not yet recruiting
• Start date: September 2020
• Est. completion date: October 2021

Study information

• Verified date: April 2020
• Source: Cairo University
• Contact: Nora Mosaad, Bachelor degree
• Phone: 01000921189
• Email: Nora.mosaad[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 184
• Est. completion date: October 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Medically compromised children. Refusal of participation.

Related Conditions & MeSH terms

• Injection Fear, Fear, Avoidance, Dental

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (9)

Armfield JM, Heaton LJ. Management of fear and anxiety in the dental clinic: a review. Aust Dent J. 2013 Dec;58(4):390-407; quiz 531. doi: 10.1111/adj.12118. Review. — View Citation

Berge KG, Agdal ML, Vika M, Skeie MS. High fear of intra-oral injections: prevalence and relationship to dental fear and dental avoidance among 10- to 16-yr-old children. Eur J Oral Sci. 2016 Dec;124(6):572-579. doi: 10.1111/eos.12305. Epub 2016 Sep 30. — View Citation

El-Housseiny AA, Alsadat FA, Alamoudi NM, El Derwi DA, Farsi NM, Attar MH, Andijani BM. Reliability and validity of the Children's Fear Survey Schedule-Dental Subscale for Arabic-speaking children: a cross-sectional study. BMC Oral Health. 2016 Apr 14;16:49. doi: 10.1186/s12903-016-0205-0. — View Citation

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

McGoldrick P, Levitt J, de Jongh A, Mason A, Evans D. Referrals to a secondary care dental clinic for anxious adult patients: implications for treatment. Br Dent J. 2001 Dec 22;191(12):686-8. — View Citation

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

Oliveira MA, Vale MP, Bendo CB, Paiva SM, Serra-Negra JM. Dental Fear Survey: a cross-sectional study evaluating the psychometric properties of the Brazilian Portuguese version. ScientificWorldJournal. 2014;2014:725323. doi: 10.1155/2014/725323. Epub 2014 Aug 11. — View Citation

Shim YS, Kim AH, Jeon EY, An SY. Dental fear & anxiety and dental pain in children and adolescents; a systemic review. J Dent Anesth Pain Med. 2015 Jun;15(2):53-61. doi: 10.17245/jdapm.2015.15.2.53. Epub 2015 Jun 30. Review. — View Citation

Vika M, Raadal M, Skaret E, Kvale G. Dental and medical injections: prevalence of self-reported problems among 18-yr-old subjects in Norway. Eur J Oral Sci. 2006 Apr;114(2):122-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dental avoidance	single question	immediate
Primary	Prevalence of intraoral injection fear	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	Prevalence of dental fear	children fear survey subscale	immediate