## Protocol Section
### Identification Module
**NCT ID:** NCT04110379

**Brief Title:** Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment

**Official Title:** Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment(Randomized Controlled Clinical Trial)

#### Organization Study ID Info
**ID:** VR for anxiety
#### Organization
**Class:** OTHER
**Full Name:** University of Alexandria
### Status Module
#### Completion Date
**Date:** 2020-10-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-04

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-10-07

**Type:** ACTUAL

#### Start Date
**Date:** 2019-07-20

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2019-10-01
**Type:** ACTUAL
**Study First Submit Date:** 2019-09-24
**Study First Submit QC Date:** 2019-09-27
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Alexandria University

#### Lead Sponsor

**Class:** OTHER

**Name:** Nourhan M.Aly

#### Responsible Party

**Investigator Affiliation:** University of Alexandria

**Investigator Full Name:** Nourhan M.Aly

**Investigator Title:** Instructor of Dental Public Health

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The aim of the study is to evaluate and compare the effect of virtual reality glasses (VR) to conventional behavior management techniques as a distraction method on child's dental anxiety during dental treatment

**Detailed Description:** The study to be conducted will be a randomized controlled clinical trial .The sample will consist of forty children presented to the Department of Pediatric Dentistry and Dental Public Health, 20 preschoolers of age ranging from 4-5 years old and 20 schoolers of age ranging from 6-8 years old. The eligible participants will be randomly divided into a study group where virtual reality glasses distraction will be used for child behavior management and a control group where conventional behavior management techniques (tell-show-do, distraction, and positive reinforcement) will be used.

### Conditions Module

**Conditions:**

- Dental Anxiety

**Keywords:**

- virtual reality

- distraction

- salivary cortisol

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** The eligible participants will be randomly and equally divided into group I (study) and group II (control). Each group will be further subdivided according to age into subgroup A (preschool aged children) and subgroup B (school aged children).

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Child behavior management will be done using virtual reality glasses distraction (Remax Fantasy Land virtual reality glasses (Schenzen Remax Co.,Ltd))

**Intervention Names:**

- Behavioral: Virtual Reality (VR)

**Label:** Virtual Reality (VR)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Child behavior management will be done using conventional behavior management techniques

**Intervention Names:**

- Behavioral: Conventional Behavior Management Techniques

**Label:** Conventional Behavior Management

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Virtual Reality (VR)

**Description:** All the dental procedures that will be done will be explained to the child using tell-show-do technique. VR glasses will be introduced to the child using tell-show-do technique and he will be given a choice of cartoon episodes to select from according to his own interest and age appropriate to view during the dental treatment. The child will be given five minutes to get familiar with the VR glasses before starting the dental treatment.

**Name:** Virtual Reality (VR)

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Conventional Behavior Management

**Description:** Conventional behavior management techniques will be done to relieve the child's dental anxiety during the dental treatment such as : tell-show-do technique, distraction, and positive reinforcement, according to the child's behavior.

**Name:** Conventional Behavior Management Techniques

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** This scale consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact

**Measure:** Preoperative Venham clinical anxiety rating scale

**Time Frame:** Baseline; at the beginning of the visit

**Description:** This scale consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact

**Measure:** Postoperative Venham clinical anxiety rating scale

**Time Frame:** post dental treatment; after 2 hours

**Description:** Each child will be asked to pool saliva in his/her mouth for 5 minutes and then passively drool it in the receiving vessel. The whole unstimulated salivary samples obtained will be centrifuged and 2 ml of each sample will be stored at -20º until being processed. The salivary samples will be analyzed for salivary cortisol using solid phase enzyme linked immunosorbent assay using DRG salivary cortisol ELISA kit.

**Measure:** Preoperative evaluation of salivary cortisol level

**Time Frame:** Baseline; at the beginning of the visit

**Description:** Each child will be asked to pool saliva in his/her mouth for 5 minutes and then passively drool it in the receiving vessel. The whole unstimulated salivary samples obtained will be centrifuged and 2 ml of each sample will be stored at -20º until being processed. The salivary samples will be analyzed for salivary cortisol using solid phase enzyme linked immunosorbent assay using DRG salivary cortisol ELISA kit.

**Measure:** Postoperative evaluation of salivary cortisol level

**Time Frame:** post dental treatment; after 2 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy children (ASA category I).
* Frankl behavior rating score 2 or 3.
* Requiring pulpotomy in one of their primary molars.

Exclusion Criteria:

* Children taking medications that interfere with measures of salivary cortisol.
* Presence of any systemic or mental disease.

**Maximum Age:** 8 Years

**Minimum Age:** 4 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Alexandria

**Country:** Egypt

**Facility:** Faculty of Dentistry, Alexandria University

**Zip:** 21512

#### Overall Officials

**Official 1:**

**Affiliation:** Faculty of Dentistry, Alexandria University, Egypt

**Name:** Yomna Alaa Eldin, BDS

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Faculty of Dentistry, Alexandria University, Egypt

**Name:** Karin M.L. Dowidar, PhD

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** Faculty of Dentistry, Alexandria University, Egypt

**Name:** Laila El Habashy, PhD

**Role:** STUDY_DIRECTOR

**Official 4:**

**Affiliation:** Faculty of Medicine, Alexandria University, Egypt

**Name:** Akram Deghady, PhD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Al-Khotani A, Bello LA, Christidis N. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial. Acta Odontol Scand. 2016 Aug;74(6):494-501. doi: 10.1080/00016357.2016.1206211. Epub 2016 Jul 13.

**PMID:** 27409593

**Citation:** Appukuttan DP. Strategies to manage patients with dental anxiety and dental phobia: literature review. Clin Cosmet Investig Dent. 2016 Mar 10;8:35-50. doi: 10.2147/CCIDE.S63626. eCollection 2016.

**PMID:** 27022303

**Citation:** Asl 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.

**PMID:** 23277857

**Citation:** Fakhruddin KS, Hisham EB, Gorduysus MO. Effectiveness of audiovisual distraction eyewear and computerized delivery of anesthesia during pulp therapy of primary molars in phobic child patients. Eur J Dent. 2015 Oct-Dec;9(4):470-475. doi: 10.4103/1305-7456.172637.

**PMID:** 26929683

**Citation:** Gadicherla S, Shenoy RP, Patel B, Ray M, Naik B, Pentapati KC. Estimation of salivary cortisol among subjects undergoing dental extraction. J Clin Exp Dent. 2018 Feb 1;10(2):e116-e119. doi: 10.4317/jced.54369. eCollection 2018 Feb.

**PMID:** 29670727

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9912

- Name: Hydrocortisone

- Relevance: LOW

- As Found: Unknown

- ID: M155245

- Name: Hydrocortisone 17-butyrate 21-propionate

- Relevance: LOW

- As Found: Unknown

- ID: M228609

- Name: Hydrocortisone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M263259

- Name: Hydrocortisone hemisuccinate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
