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

NCT ID: NCT05157438

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-03-01

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.

Detailed Description

Most of dental procedures are accompanied by pain and discomfort which subsequently adversely affect the patient's cooperation and willingness to complete or undergo the procedures. This negative behavior compromises the efficiency and quality of the delivered dental treatment, to the extent that it may not be completed. Therefore, behavior management techniques have been introduced to the field of pediatric dentistry to effectively manage the child anxiety and improve the child's experience in dental office to establish a positive child-dentist relationship. The virtual reality (VR) is considered a behavior management technique as well as a distraction tool, as it modifies the child's attitude. Thus, it can be used in the dental practice to help the dentist to control the child during the treatment procedure. The study's design is a cross-over, split mouth trial in which the procedure is planned to be on three visits, as the following: baseline visit (v0) for diagnosis, examination and inclusion, first visit (v1) and second visit (v2) for treatment sessions. A follow up visit (v3) may be needed for younger patients who need space maintenance for the extraction site. allocated and randomized equally into two groups according to the intervention assigned in the first treatment session: Group I (virtual reality group) and Group II (screen program group). In both groups, children will be allowed to choose an animation or cartoon from a list pre-prepared by the investigator in order to watch a show of their own choice, to augment the effect of distraction. Both groups will be managed and operated by the same operator who is the research investigator. Treatments were completed in two separate sessions, two weeks apart as a washout period, to avoid any carry-over effect. Each patient will have two teeth extracted, one on each side, on two successive visits, with two weeks apart as a washout period. The required sample size was calculated using the IBMª SPSSª Sample Powerª version 3.0.1 (IBMª Corp., Armonk, NY, USA). Subjects will be recruited from the outpatient clinic in Pediatric Dentistry and Dental Public health Department. Faculty of Dentistry, Cairo University, Egypt. Patients will be screened by the research investigator until the target population is achieved. The outcome data and results will be independently collected from each participant by the researcher, examined, organized and analyzed under the supervision of the assistant supervisor. Any missing data will be revised and handled with the best techniques according to the type of data missed. All data will be entered and stored on a secured personal computer in coded and password locked files. Backup of data on an external hard disc in order to prevent any data loss. Results will be statistically analyzed by using statistical package of social sciences (SPSS 26.0, IBM/SPSS Inc., Chicago, IL). There are two types of statistical methods Descriptive statistics and Analytical or inferential statistics. In this study, no data monitoring committee will be needed since it is a study with known minimal risks. The Main Supervisor will monitor this study. Auditing will be done by the main and co-supervisors to assure quality of the research methods, restorative technique and interventions.

Conditions

Dental Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group I (virtual reality group)

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.

Group Type: EXPERIMENTAL

virtual reality device

Intervention Type: 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 II (screen program group).

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.

Group Type: ACTIVE_COMPARATOR

screen programs

Intervention Type: BEHAVIORAL

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

Interventions

virtual reality device

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

Intervention Type: BEHAVIORAL

screen programs

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

Intervention Type: BEHAVIORAL

Other Intervention Names

tablets, televisions

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amal Salem Yousry Mahrouse

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal S Abdelatty, Masters

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Cairo University

Role: STUDY_CHAIR

11 El-Saraya St. - Manial - Cairo

Locations

Faculty of Dentistry Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Amal S Abdelatty

Role: CONTACT

amal.mahrouse@dentistry.cu.edu.eg

+201092623145

Facility Contacts

ola omar, professor

Role: primary

dentmail@dentistry.cu.edu.eg

23634965 ext. +202

hala mohyeldin, professor

Role: backup

pedo@dentistry.cu.edu.eg

23642938 ext. +202

References

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Reference Type: BACKGROUND

PMID: 31723668 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 32440065 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 24621518 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23277857 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25256207 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30324926 (View on PubMed)

Other Identifiers

VR in Child Anxiety

Identifier Type: -

Identifier Source: org_study_id