A Novel Approach in Reducing Dental Pain and Anxiety of Pediatric Patient During Local Anesthesia.

Pain Clinical Trial

Official title:

A Novel Approach in Reducing Dental Pain and Anxiety of Pediatric Patient During Local Anesthesia. A Clinical Experimental Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585061
• Other study ID #: FPGRP/2020/489/269
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: February 18, 2021

Study information

• Verified date: November 2021
• Source: Riyadh Elm University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine the efficacy of sweet in compare to virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.

The clinical trial is a randomized split-mouth assignment. Included patients are 5 - 12 years old requiring local anesthetic infiltration with conventional syringe (CS) for conservative treatment of two primary maxillary molars bilaterally.

Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, whereas sweet is allocated to first local anesthesia procedure and VR is allocated to second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale (VAS). Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anesthesia method - CS+sweet or CS+VR.

Description:

Achieving local anesthesia in children is one of the critical aspects of pain management and they effect the quality of treatment as well as behavior of child.

A contemporary engaging form of distraction is represented by virtual reality devices. Virtual reality (VR) devices create a virtual environment of view and sound that allow patients to be immersed in an interactive, simulated world to distract them from pain. The VR devices have a wide viewing field and three-dimensional displays that project the images right in front of the user. They not only show potentially attractive audio-visual stimuli, but also exclude all other visual environmental stimuli that may affect the patient.

While sweet-tasting reduce signs of pain during painful procedures. This effect is considered to be mediated both by the release of endorphins and by a pre absorptive mechanism related to the sweet taste.

The aim of this study is to determine the efficacy of sweet-testing compare to a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.

The device used in this study is Harga Miniso Vr Glass 3d terbaru, compatible with a mobile phone.

The sweet used is xylitol tablet The clinical trial is a randomized split-mouth assignment. Included patients are healthy positive children 5-12 years old requiring local anesthetic infiltration for conservative treatment of two primary maxillary molars bilaterally.

Eligible patients undergo two single-visit treatments after measurement of dental fear prior to each according to the Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS). Local anesthetic is delivered through buccal infiltration with conventional syringe, where is the sweet-test applied with first local anesthesia procedure and the virtual reality distraction is allocated to second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale. Secondary outcome measures: self-reported anxiety during injection on Facial Image Scale; pain-related behavior according to Faces, Legs, Activity, Cry, Consolability (FLACC) scale; heart-rate dynamics; patient preference to local anesthesia method - sweet test infiltration or virtual reality device-assisted injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 18, 2021
• Est. primary completion date: February 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Patients, identified as positive or definitely positive through Frankl behavioral rating scale.

• Children, requiring local anesthesia infiltration for conservative treatment of two primary upper jaw molars bilaterally.

• Children without previous experience with local anesthesia for dental treatment.

• Obtained informed consent from parents or gave-givers to participate in the study.

Exclusion Criteria:

• Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic non-epileptic events, sensitivity to flashing light or motion.

• Vision requiring correction with eyeglasses.

• Recent injury to the eyes or face that prevents comfortable use of VR hardware or software.

• Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.

• Patients with allergy to local anesthetics, xylitol.

• Children, who are first time ever dental patients.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

Drug:
• Lidocaine Hydrochloride
1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle

Device:
• Virtual reality device (Harga Miniso Vr Glass 3d terbaru)
Virtual reality device (Harga Miniso Vr Glass 3d terbaru) is placed on the face of the patient, playing a video of Tom and Jerry cartoon. Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized

Dietary Supplement:
• Xylitol
Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized while xylitol tablet putted under tongue

Locations

Country	Name	City	State
Saudi Arabia	AbdulRahman Alasmari	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Elm University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (11)

Bikmoradi A, Khaleghverdi M, Seddighi I, Moradkhani S, Soltanian A, Cheraghi F. Effect of inhalation aromatherapy with lavender essence on pain associated with intravenous catheter insertion in preschool children: A quasi-experimental study. Complement Th — View Citation

Buchanan H, Niven N. Validation of a Facial Image Scale to assess child dental anxiety. Int J Paediatr Dent. 2002 Jan;12(1):47-52. — View Citation

Keefe FJ, Rumble ME, Scipio CD, Giordano LA, Perri LM. Psychological aspects of persistent pain: current state of the science. J Pain. 2004 May;5(4):195-211. Review. — View Citation

Locker D, Thomson WM, Poulton R. Psychological disorder, conditioning experiences, and the onset of dental anxiety in early adulthood. J Dent Res. 2001 Jun;80(6):1588-92. — View Citation

Malviya S, Voepel-Lewis T, Burke C, Merkel S, Tait AR. The revised FLACC observational pain tool: improved reliability and validity for pain assessment in children with cognitive impairment. Paediatr Anaesth. 2006 Mar;16(3):258-65. — View Citation

Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7. — View Citation

Messieha Z. Risks of general anesthesia for the special needs dental patient. Spec Care Dentist. 2009 Jan-Feb;29(1):21-5; quiz 67-8. doi: 10.1111/j.1754-4505.2008.00058.x. Review. — View Citation

ten Berge M, Veerkamp JS, Hoogstraten J, Prins PJ. Childhood dental fear in the Netherlands: prevalence and normative data. Community Dent Oral Epidemiol. 2002 Apr;30(2):101-7. — View Citation

Thomson WM, Locker D, Poulton R. Incidence of dental anxiety in young adults in relation to dental treatment experience. Community Dent Oral Epidemiol. 2000 Aug;28(4):289-94. — View Citation

von Baeyer CL, Spagrud LJ. Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years. Pain. 2007 Jan;127(1-2):140-50. Epub 2006 Sep 25. Review. — View Citation

Zhang C, Qin D, Shen L, Ji P, Wang J. Does audiovisual distraction reduce dental anxiety in children under local anesthesia? A systematic review and meta-analysis. Oral Dis. 2019 Mar;25(2):416-424. doi: 10.1111/odi.12849. Epub 2018 Sep 21. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain felt during injection using visual analogue scale	Self-reported pain by the patient immediately after local anaesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.	Immediately after local anesthetic delivery
Secondary	Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale	Evaluated by the outcomes assessor. The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain	During local anesthesia procedure
Secondary	Self-reported anxiety during injection evaluated on FIS	The Facial Image Scale (FIS) comprises a row of five faces from very unhappy (score 5) to very happy (score 1).	Immediately after local anesthetic delivery
Secondary	Heart rate dynamics of the patient	Patient's left index finger is connected to a portable recording pulse oximeter for children.	Baseline (Start: in the waiting room), at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.
Secondary	Assessment of self-reported dental fear on CFSS-DS questionnaire	After each procedure	At least 5 minutes before local anesthesia