Injection Fear, Fear, Avoidance, DentalNCT04335500
Prevalance of Intraoral Injection Fear
An observational study of Injection Fear, Fear, Avoidance, Dental, run by Cairo University.
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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Fear, Fear, Avoidance, Dental
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children from 8 to 10 years with or without previous dental experience
Who may be able to join
- : school aged children (8 to10) years old. With or without previous dental experience
Who cannot join
- Medically compromised children. Refusal of participation.
Trial locations and contacts
No sites are listed yet.
About this study
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
Aim of the study
- Estimate the prevalence of intraoral injection fear and its relationship to dental fear among 8-10 years children.
- 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)
- Conditions
- Injection Fear, Fear, Avoidance, Dental
- Medical subject headings
- Iatrophobia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediate
Secondary outcomes (1)
Prevalence of dental fear
children fear survey subscale
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Injection Fear, Fear, Avoidance, DentalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Mohamed Mosaad Hussien, Cairo University
- Investigators
- Pediatric dentistry department, Study chair, Faculty of oral and dental medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335500
- Sponsor's protocol ID
- Inraoral injection fear
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 28879259Vika 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 16630303El-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 27079656Armfield 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 24320894Oliveira 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 25184153McGoldrick 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 11792115Marshman, 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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04335500
- Acronym / sponsor ID
- Inraoral injection fear
- Conditions
- Injection Fear, Fear, Avoidance, Dental
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study
- Estimate the prevalence of intraoral injection fear and its relationship to dental fear among 8-10 years children.
- Explore the possible consequences of such problems in terms of avoidance of dental and medical care.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children from 8 to 10 years with or without previous dental experience
Key inclusion criteria (1 listed)
- : school aged children (8 to10) years old. With or without previous dental experience
Key exclusion criteria (1 listed)
- Medically compromised children. Refusal of participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Prevalence of dental fear
Time frame: immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Background: PubMed 28879259Shim 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.
- Background: PubMed 16630303Vika 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.
- Background: PubMed 27079656El-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.
- Background: PubMed 24320894Armfield 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.
- Background: PubMed 25184153Oliveira 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.
- Background: PubMed 11792115McGoldrick 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.
- BackgroundMarshman, 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
- BackgroundMednick, 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
- Results publication: PubMed 27689943Berge 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pediatric dentistry department study chair
Faculty of oral and dental medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Injection Fear, Fear, Avoidance, Dental, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nora Mosaad, Bachelor degree (01000921189, Nora.mosaad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of intraoral injection fear (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04335500, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.