Effect of VR vs Screens on Children's Dental Anxiety, Pain and Behavior

NCT05157438 | Unknown DMC

• 1 other identifier: VR in Child Anxiety
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Virtual reality distraction is intended to reduce the pain experience by distracting the patient attention from the pain stimulating procedure. Then, it breaks the cycle of negative experiences by improving the dental experience. The study's aim is to compare the effect of virtual reality to the effect of screen programs on dental anxiety, pain and behavior at different time points among children undergoing dental treatment under local anesthesia. The null hypothesis assumes that virtual reality has no effect on reducing the children's pain or anxiety and there is no difference between virtual reality and screen programs in improving the children's behavior and dental experience. The study's design is a cross-over, split mouth trial in which each patient will have similar dental treatments on each side, but with different distraction techniques.

Conditions

Dental Anxiety

Keywords

virtual reality

Outcome Measures

Primary Outcomes (1)

• RMS Pictorial Scale: A scale to assess the change in dental anxiety through the dental procedure

  The scale consists of row of 5 photographs of a child showing 5 different faces ranging from happy to very unhappy. The child is asked to choose the face that looks like what they feel at the moment. The score is recorded by giving value of 1 to happy and value of 5 to very unhappy. The RMS-pictorial scale is chosen for simple and easy for the child to understand, has 2 sets of photographs for boys and for girls, which gives efficient evaluation of dental anxiety.

  The dental anxiety is measured during same single visit. There is no follow up and no specific time duration for the visit. Pre-operative anxiety: before administration of local anesthesia and Post-operative anxiety: after dental extraction.

Study Arms (2)

Group I (virtual reality group)

EXPERIMENTAL

The virtual reality device is a 3D head-mounted display which provides a wide field of view and a high-resolution visual display, the system consists of head mounted glasses, a compatible smartphone and headphones. This technology creates a computer stimulated virtual environment.

Behavioral: virtual reality device

Group II (screen program group).

ACTIVE COMPARATOR

the screens shows such as cartoons, animation movies or recorded video games are used for distraction during dental treatments. They could be seen on tablets, iPads or LCD screen.

Behavioral: screen programs

Interventions

virtual reality device BEHAVIORAL

The virtual reality device is a 3D head-mounted display which provides a wide field of view and a high-resolution visual display, it has been used to manage cases of phobia and extreme fear through the use of exposure-based treatment programs. The virtual reality system consists of head mounted glasses, a compatible smartphone and headphones. This technology creates a computer stimulated virtual environment into which the child can be entirely immersed. It works to distract the brain from the painful procedure and reduce the perception of pain stimuli

Group I (virtual reality group)

screen programs BEHAVIORAL

the screens are used for distraction during dental treatments. they could be on tablets, iPads or televisions.

Also known as: tablets, televisions

Group II (screen program group).

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between 5-7 years old age.
• Both genders.
• First dental visit
• Positive and definitely positive behavior according to Frankel behavior scale.
• Two or more badly decayed primary maxillary first molars beyond repair and need to be extracted.
• Systemically and mentally healthy.

You may not qualify if:

• History of systemic or mental conditions.
• Special health care needs who require pharmacological management prior to dental treatment.
• Acute dental pain or trauma.
• Extremely uncooperative children who require being treated under general anesthesia, negative and definitely negative according to Frankel behavior scale

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Egypt

RECRUITING

Related Publications (6)

• Nunna M, Dasaraju RK, Kamatham R, Mallineni SK, Nuvvula S. Comparative evaluation of virtual reality distraction and counter-stimulation on dental anxiety and pain perception in children. J Dent Anesth Pain Med. 2019 Oct;19(5):277-288. doi: 10.17245/jdapm.2019.19.5.277. Epub 2019 Oct 30.

  PMID: 31723668 BACKGROUND

• Rao DG, Havale R, Nagaraj M, Karobari NM, Latha AM, Tharay N, Shrutha SP. Assessment of Efficacy of Virtual Reality Distraction in Reducing Pain Perception and Anxiety in Children Aged 6-10 Years: A Behavioral Interventional Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):510-513. doi: 10.5005/jp-journals-10005-1694.

  PMID: 32440065 BACKGROUND

• Tanja-Dijkstra K, Pahl S, White MP, Andrade J, Qian C, Bruce M, May J, Moles DR. Improving dental experiences by using virtual reality distraction: a simulation study. PLoS One. 2014 Mar 12;9(3):e91276. doi: 10.1371/journal.pone.0091276. eCollection 2014.

  PMID: 24621518 BACKGROUND

• 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 BACKGROUND

• Nuvvula S, Alahari S, Kamatham R, Challa RR. Effect of audiovisual distraction with 3D video glasses on dental anxiety of children experiencing administration of local analgesia: a randomised clinical trial. Eur Arch Paediatr Dent. 2015 Feb;16(1):43-50. doi: 10.1007/s40368-014-0145-9. Epub 2014 Sep 26.

  PMID: 25256207 BACKGROUND

• Niharika P, Reddy NV, Srujana P, Srikanth K, Daneswari V, Geetha KS. Effects of distraction using virtual reality technology on pain perception and anxiety levels in children during pulp therapy of primary molars. J Indian Soc Pedod Prev Dent. 2018 Oct-Dec;36(4):364-369. doi: 10.4103/JISPPD.JISPPD_1158_17.

  PMID: 30324926 BACKGROUND

MeSH Terms

Interventions

Tablets; Television

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Amal S Abdelatty, Masters

  Cairo University

  PRINCIPAL INVESTIGATOR

• Cairo University

  11 El-Saraya St. - Manial - Cairo

  STUDY CHAIR

Central Study Contacts

Amal S Abdelatty

CONTACT

+201092623145; amal.mahrouse@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 15, 2021
• Study Start: October 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

EG (1)