Nurse's RoleNCT04348903
Virtual Reality Distraction Versus Positive Pre-Visit Imagery Intervention on Children's Dental Fear and Anxiety
A study testing Virtual Reality Distraction and Positive Pre-Visit Imagery Intervention in people with Nurse's Role, run by Alexandria University.
Trial summary
Aim This study aimed to determine the effect of virtual reality distraction versus positive pre-visit imagery intervention on children's dental fear and anxiety during local anaesthesia injection. Research Hypotheses 1. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role
- What is being tested?
- Virtual Reality Distraction and Positive Pre-Visit Imagery Intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2020to 1 May 2020
- Phase
- Interventional
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age ranged from 4- 6 years.
- Had a previous experience of dental local anaesthesia injection.
- Had carious mandibular primary molar and planned for restorative dental treatment.
Who cannot join
- Age more than 6 years.
- visual or auditory deficits.
- chronic or mental disabilities that affect their understanding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Virtual Reality Distraction Versus Positive Pre-Visit Imagery Intervention on Children's Dental Fear and Anxiety : Implications for Evidence-Based Practice
Aim
This study aimed to determine the effect of virtual reality distraction versus positive pre-visit imagery intervention on children's dental fear and anxiety during local anaesthesia injection.
Research Hypotheses
- Children who receive Virtual reality distraction or Positive pre-visit imagery intervention exhibit less dental fear and anxiety levels during LA injection than those who do not.
- Children who receive Virtual reality distraction exhibit less dental fear and anxiety levels during LA injection than those who receive Positive pre-visit imagery intervention.
Read the detailed description
Promoting children's health is a crucial nursing role. Dental health and psychological well-being are basic components of the health promotion for young children. Dental procedures especially local anesthesia injection is one of the most unpleasant experiences for young children. Dental Fear and Anxiety are considered pervasive psychological problems accompanied with strong negative feelings among a large portion of young children. Basically, dental fear and anxiety have been reported as one of the most important reasons for avoidance of dental treatments among young children, thereby results in an adverse effects on their oral and psychological health.
Nurses face a great challenge to minimize dental fear and anxiety and stabilize young children psychologically during restorative dental procedures. Such stabilization is the cornerstone of successful local anaesthesia injection and facilitating dentist's mission.
Virtual reality refers to a human-computer interface that completely immerse the child in a simulated environment. It integrates multiple perceptual senses including; the visual, auditory and kinaesthetic stimulation modalities. Virtual reality diverts children's attention away from the negative feelings associated with unpleasant experience.
Positive pre-visit imagery is one of the superior cognitive- behavioral interventions. It is kind of psychological preparation that is designed to provide children with a step-by-step explanation of the dental local anaesthesia injection in an attractive approach. It helps them to anticipate, deal with, and be empowered to gain mastery over the events they will experience. It also plays a role in counteracting the distorted beliefs that invading the children's conscious awareness.
- Conditions
- Nurse's Role
- Being tested
- Virtual Reality Distraction, Positive Pre-Visit Imagery Intervention
- Keywords
- Virtual Reality, Positive Pre-visit Imagery, Dental Fear, Dental anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DistractionBehavioural
The researchers will prepare the VR device. The researches will explain the aim of using VR and adopt tell-show-do technique in introducing VR Glasses. Once VR device headset will be adapted to the child's head size and adjusted in front of his/her eyes, the selected 3D cartoon movie will be played in the waiting room and throughout the procedure of dental LA injection. After ensuring that the child is fully immersed in the cartoon movie, a needle of local anesthetic agent will be prepared and injected after explanation of the procedure.
Positive Pre-Visit Imagery InterventionBehavioural
Short narrative visual information regarding the dental chair, environment and equipment will be provided. It will be done through showing children an interactive book that contained photographs of A4 size, depicting three children model aged 4 - 6 years who are smiling while sitting in the dental chair and cooperative with the dentist. Benefit of LA in alleviating pain will be explained. The researchers also will explore the children's reflection of the children model and allow them ask questions relevant to LA injection.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Distraction | Experimental | Virtual reality refers to a human-computer interface that completely immerse the child in a simulated environment. It integrates multiple perceptual senses including; the visual, auditory and kinaesthetic stimulation modalities. Virtual reality diverts children's attention away from the negative feelings associated with unpleasant experience. Receives: Behavioral: Virtual Reality Distraction |
| Positive Pre-Visit Imagery Intervention | Experimental | Positive pre-visit imagery is one of the superior cognitive- behavioral interventions. It is kind of psychological preparation that is designed to provide children with a step-by-step explanation of the dental local anaesthesia injection in an attractive approach Receives: Behavioral: Positive Pre-Visit Imagery Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Local Anaesthesia Injection Fear Scale
This was scale developed by the researchers after thorough review of related literature to measure children's dental fear during dental local anaethesia injection (Riba et al., 2017 \& Malhotra et al., 2018). It consisted of 15 items that emphasized on observing children's fear behavioral response. The scale comprises of two main categories including avoidant behaviors such as refuses to leave caregiver, sits on the dental chair or opens mouth in addition to over-exaggerated behaviors, such as attempts to dislodge syringe, kicks the doctor and leaves the chair. Each item was measured on a two-points Likert scale ranged from zero "behavior is not present" to one "behavior is present".
Measured: 10 minutes
Venham's Dental Clinical Anxiety Rating Scale
This scale was developed by Venham and Kremer (1979) to quantify the anxious behaviors of 4-6 years-old children during situational dental anxiety. It is consisted of 6 items that were rated from relaxed to out of contact and were given numeric digit from zero to five respectively as follows: The scale was reliable and valid and can be easily integrated in clinical or research activities. Its content validity was 0.91 and a test-retest reliability revealed to be 0.93.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start16 Apr 2020 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohour Ibrahim Mahmoud Rashwan, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348903
- Sponsor's protocol ID
- 2113042020
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Addicks SH, McNeil DW, Randall CL, Goddard A, Romito LM, Sirbu C, Kaushal G, Metzger A, Weaver BD. Dental Care-Related Fear and Anxiety: Distress Tolerance as a Possible Mechanism. JDR Clin Trans Res. 2017 Jul;2(3):304-311. doi: 10.1177/2380084417691962. Epub 2017 Feb 9.
PubMed 28879250Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.
PubMed 23277857Fox C, Newton JT. A controlled trial of the impact of exposure to positive images of dentistry on anticipatory dental fear in children. Community Dent Oral Epidemiol. 2006 Dec;34(6):455-9. doi: 10.1111/j.1600-0528.2006.00303.x.
PubMed 17092274Gangwal RR, Rameshchandra Badjatia S, Harish Dave B. Effect of Exposure to Positive Images of Dentistry on Dental Anxiety among 7 to 12 Years Old Children. Int J Clin Pediatr Dent. 2014 Sep-Dec;7(3):176-9. doi: 10.5005/jp-journals-10005-1260. Epub 2015 Feb 9.
PubMed 25709297Ramos-Jorge ML, Ramos-Jorge J, Vieira de Andrade RG, Marques LS. Impact of exposure to positive images on dental anxiety among children: a controlled trial. Eur Arch Paediatr Dent. 2011 Aug;12(4):195-9. doi: 10.1007/BF03262806.
PubMed 21806903Malhotra R, Gandhi K, Kumar D, Ahuja S, Kapoor R, Sahni A. A Comparative Study to evaluate Parent's Ability to assess Dental Fear in their 6- to 10-year-old Children using Children's Fear Survey Schedule-Dental Subscale. Int J Clin Pediatr Dent. 2018 May-Jun;11(3):205-209. doi: 10.5005/jp-journals-10005-1512. Epub 2018 Jun 1.
PubMed 30131642Venham LL, Gaulin-Kremer E. A self-report measure of situational anxiety for young children. Pediatr Dent. 1979 Jun;1(2):91-6. No abstract available.
PubMed 399677
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Distraction Versus Positive Pre-Visit Imagery Intervention on Children's Dental Fear and Anxiety : Implications for Evidence-Based Practice
- ClinicalTrials.gov ID
- NCT04348903
- Acronym / sponsor ID
- 2113042020
- Conditions
- Nurse's Role
- Keywords
- Virtual Reality, Positive Pre-visit Imagery, Dental Fear, Dental anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 16 Apr 2020 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 16 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
This study aimed to determine the effect of virtual reality distraction versus positive pre-visit imagery intervention on children's dental fear and anxiety during local anaesthesia injection.
Research Hypotheses
- Children who receive Virtual reality distraction or Positive pre-visit imagery intervention exhibit less dental fear and anxiety levels during LA injection than those who do not.
- Children who receive Virtual reality distraction exhibit less dental fear and anxiety levels during LA injection than those who receive Positive pre-visit imagery intervention.
Detailed description
Promoting children's health is a crucial nursing role. Dental health and psychological well-being are basic components of the health promotion for young children. Dental procedures especially local anesthesia injection is one of the most unpleasant experiences for young children. Dental Fear and Anxiety are considered pervasive psychological problems accompanied with strong negative feelings among a large portion of young children. Basically, dental fear and anxiety have been reported as one of the most important reasons for avoidance of dental treatments among young children, thereby results in an adverse effects on their oral and psychological health.
Nurses face a great challenge to minimize dental fear and anxiety and stabilize young children psychologically during restorative dental procedures. Such stabilization is the cornerstone of successful local anaesthesia injection and facilitating dentist's mission.
Virtual reality refers to a human-computer interface that completely immerse the child in a simulated environment. It integrates multiple perceptual senses including; the visual, auditory and kinaesthetic stimulation modalities. Virtual reality diverts children's attention away from the negative feelings associated with unpleasant experience.
Positive pre-visit imagery is one of the superior cognitive- behavioral interventions. It is kind of psychological preparation that is designed to provide children with a step-by-step explanation of the dental local anaesthesia injection in an attractive approach. It helps them to anticipate, deal with, and be empowered to gain mastery over the events they will experience. It also plays a role in counteracting the distorted beliefs that invading the children's conscious awareness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Distraction | Experimental | Behavioral: Virtual Reality DistractionVirtual reality refers to a human-computer interface that completely immerse the child in a simulated environment. It integrates multiple perceptual senses including; the visual, auditory and kinaesthetic stimulation modalities. Virtual reality diverts children's attention away from the negative feelings associated with unpleasant experience. |
| Positive Pre-Visit Imagery Intervention | Experimental | Behavioral: Positive Pre-Visit Imagery InterventionPositive pre-visit imagery is one of the superior cognitive- behavioral interventions. It is kind of psychological preparation that is designed to provide children with a step-by-step explanation of the dental local anaesthesia injection in an attractive approach |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age ranged from 4- 6 years.
- Had a previous experience of dental local anaesthesia injection.
- Had carious mandibular primary molar and planned for restorative dental treatment.
Key exclusion criteria (3 listed)
- Age more than 6 years.
- visual or auditory deficits.
- chronic or mental disabilities that affect their understanding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality DistractionThe researchers will prepare the VR device. The researches will explain the aim of using VR and adopt tell-show-do technique in introducing VR Glasses. Once VR device headset will be adapted to the child's head size and adjusted in front of his/her eyes, the selected 3D cartoon movie will be played in the waiting room and throughout the procedure of dental LA injection. After ensuring that the child is fully immersed in the cartoon movie, a needle of local anesthetic agent will be prepared and injected after explanation of the procedure. | Behavioural | Virtual Reality Distraction |
| Positive Pre-Visit Imagery InterventionShort narrative visual information regarding the dental chair, environment and equipment will be provided. It will be done through showing children an interactive book that contained photographs of A4 size, depicting three children model aged 4 - 6 years who are smiling while sitting in the dental chair and cooperative with the dentist. Benefit of LA in alleviating pain will be explained. The researchers also will explore the children's reflection of the children model and allow them ask questions relevant to LA injection. | Behavioural | Positive Pre-Visit Imagery Intervention |
Primary outcome
Dental Local Anaesthesia Injection Fear Scale
Time frame: 10 minutes
This was scale developed by the researchers after thorough review of related literature to measure children's dental fear during dental local anaethesia injection (Riba et al., 2017 \& Malhotra et al., 2018). It consisted of 15 items that emphasized on observing children's fear behavioral response. The scale comprises of two main categories including avoidant behaviors such as refuses to leave caregiver, sits on the dental chair or opens mouth in addition to over-exaggerated behaviors, such as attempts to dislodge syringe, kicks the doctor and leaves the chair. Each item was measured on a two-points Likert scale ranged from zero "behavior is not present" to one "behavior is present".
Venham's Dental Clinical Anxiety Rating Scale
Time frame: 10 minutes
This scale was developed by Venham and Kremer (1979) to quantify the anxious behaviors of 4-6 years-old children during situational dental anxiety. It is consisted of 6 items that were rated from relaxed to out of contact and were given numeric digit from zero to five respectively as follows: The scale was reliable and valid and can be easily integrated in clinical or research activities. Its content validity was 0.91 and a test-retest reliability revealed to be 0.93.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Background: PubMed 28879250Addicks SH, McNeil DW, Randall CL, Goddard A, Romito LM, Sirbu C, Kaushal G, Metzger A, Weaver BD. Dental Care-Related Fear and Anxiety: Distress Tolerance as a Possible Mechanism. JDR Clin Trans Res. 2017 Jul;2(3):304-311. doi: 10.1177/2380084417691962. Epub 2017 Feb 9.
- Background: PubMed 23277857Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.
- Background: PubMed 17092274Fox C, Newton JT. A controlled trial of the impact of exposure to positive images of dentistry on anticipatory dental fear in children. Community Dent Oral Epidemiol. 2006 Dec;34(6):455-9. doi: 10.1111/j.1600-0528.2006.00303.x.
- Background: PubMed 25709297Gangwal RR, Rameshchandra Badjatia S, Harish Dave B. Effect of Exposure to Positive Images of Dentistry on Dental Anxiety among 7 to 12 Years Old Children. Int J Clin Pediatr Dent. 2014 Sep-Dec;7(3):176-9. doi: 10.5005/jp-journals-10005-1260. Epub 2015 Feb 9.
- Background: PubMed 21806903Ramos-Jorge ML, Ramos-Jorge J, Vieira de Andrade RG, Marques LS. Impact of exposure to positive images on dental anxiety among children: a controlled trial. Eur Arch Paediatr Dent. 2011 Aug;12(4):195-9. doi: 10.1007/BF03262806.
- Background: PubMed 30131642Malhotra R, Gandhi K, Kumar D, Ahuja S, Kapoor R, Sahni A. A Comparative Study to evaluate Parent's Ability to assess Dental Fear in their 6- to 10-year-old Children using Children's Fear Survey Schedule-Dental Subscale. Int J Clin Pediatr Dent. 2018 May-Jun;11(3):205-209. doi: 10.5005/jp-journals-10005-1512. Epub 2018 Jun 1.
- Background: PubMed 399677Venham LL, Gaulin-Kremer E. A self-report measure of situational anxiety for young children. Pediatr Dent. 1979 Jun;1(2):91-6. No abstract available.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Distraction and Positive Pre-Visit Imagery Intervention in people with Nurse's Role, run by Alexandria 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 3 inclusion and 3 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 16 Apr 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 Zohour I Rashwan, PhD (35094573 ext. 00973, zohour.rashwan@alex-nursing.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Local Anaesthesia Injection Fear Scale (time frame: 10 minutes). The study lists 2 primary outcomes in all. 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 NCT04348903, which also lists 7 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 16 Apr 2020.