CClinicalTrials.gg
Status unknownNCT04335500Updated May 4, 2020

Prevalance of Intraoral Injection Fear

An observational study in Injection Fear, Fear, Avoidance, Dental, sponsored by Cairo University. Status unknown. Open to participants aged 8 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-04.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
184
Ages
8 Years to 10 Years
Sex
All
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Study 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.
Read the 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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Conditions studied

  • Injection Fear, Fear, Avoidance, Dental
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In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 10 Years
Sexes eligible
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

Exclusion Criteria:

  • Medically compromised children. Refusal of participation.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
184 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: immediate

Secondary outcomes

  1. Prevalence of dental fear

    children fear survey subscale

    Time frame: immediate

Other outcomes

  1. Dental avoidance

    single question

    Time frame: immediate

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 28879259 ↗
  • 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. doi: 10.1111/j.1600-0722.2006.00335.x. PubMed 16630303 ↗
  • 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. PubMed 27079656 ↗
  • 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. PubMed 24320894 ↗
  • 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. PubMed 25184153 ↗
  • 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. doi: 10.1038/sj.bdj.4801270. PubMed 11792115 ↗
  • 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
  • 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. PubMed 27689943 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04335500
Lead sponsor
Cairo University
Responsible party
Nora Mohamed Mosaad Hussien (Principle investigator, Resident at pediatric dentistry department Nora Mohamed Mosaad, Cairo University) — Principal investigator
First posted
Apr 6, 2020
Start date
Sep 2020 (estimated)
Primary completion
Sep 2021 (estimated)
Completion
Oct 2021 (estimated)
Last update
May 4, 2020

Study contacts

Nora Mosaad, Bachelor degree
Contact
Nora.mosaad@dentistry.cu.edu.eg
01000921189
Pediatric dentistry department
study chair · Faculty of oral and dental medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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