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Completed

NCT Number: NCT07722221

Effectiveness of Virtual Reality Technique on Children

Studying the effect of using virtual reality technique in managing pain, anxiety, and vital signs among pediatric dental patients.

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Key information

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty Of Dentistry ,Tishreen University, Latakia, Syria

Latakia, Syria

About this study

Local anaesthesia is essential for pain control during pediatric dental procedures, yet its administration can cause significant anxiety and distress in children.

Recent innovations aim to improve the delivery of anesthesia to make it less painful and more acceptable. This randomized clinical trial studied the effect of using virtual reality technique in managing pain, anxiety, and vital signs among pediatric dental patients. A total of 64 healthy children aged 6 to 10 years participated in the study. The children were randomly assigned to one of two groups. Pain perception was measured using Wong-Baker FACES Pain Rating Scale. Anxiety was evaluated using Venham Picture Test. Vital signs, including pulse rate, oxygen saturation and blood pressure were monitored at baseline and during treatment. Satisfaction levels were assessed for the pediatric patients using child-friendly satisfaction questionnaires

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 6-10 years.
  • Physically healthy with no neurological disorders or systemic diseases.
  • Children classified as positive" or "negative-positive" according to the modified Frankl Behavioral Rating Scale.
  • Not taking any sedatives or analgesics drugs

Exclusion criteria

  • Uncooperative children who exhibit clear behavioral problems.
  • Children with systemic diseases or disorders that may interfere with local anesthesia.
  • Use of any medications that may affect vital signs or pain response.
  • Presence of infection at the injection site.

Treatment and study plan

Conventional

Device

Behaviour management was done using the conventional techniques (TSD, positive reinforcement) during Local anaesthesia and treatment (extraction)

Virtual reality

Device

Behaviour management was done using Virtual Reality technique during Local anaesthesia and treatment (extraction)

Primary outcomes

  1. Pain level during dental anesthesia and treatment

    Time frame: From the start of local anesthetic injection until completion of extraction, assessed up to 30 minutes.

    Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale to measure children's self-reported pain, It's a self-reported scale with six cartoon faces representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children were asked to point to the face that best described their pain.

    Higher scores on either scale indicated greater pain intensity.

  2. Anxiety level during anesthesia and treatment

    Time frame: From the start of local anesthetic injection until completion of extraction, assessed up to 30 minutes.

    Anxiety was assessed using the Venham Picture Test (VPT), a self-reported measure of dental anxiety in children. The scale consists of 8 pairs of drawings, with the child selecting the picture that best reflects their feelings at each pair. Scores range from 0 to 8, where 0 indicates no anxiety and 8 indicates the highest level of anxiety. Higher scores indicate greater anxiety.

Secondary outcomes

  1. Pulse rate

    Time frame: From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.]

    Pulse rate was measured using a pulse oximeter and recorded in beats per minute (bpm). Readings were recorded at predefined intervals. Increases in heart rate indicated heightened stress or discomfort during the procedure.

  2. Oxygen saturation

    Time frame: From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.

    Peripheral oxygen saturation (SpO₂) was measured using a pulse oximeter and recorded as percentage of oxygen saturation (%). Readings were recorded at predefined intervals. Decreases in SpO2 indicated heightened stress or discomfort during the procedure

  3. Blood pressure

    Time frame: From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of extraction, assessed up to 35 minutes.

    Blood pressure was measured using an automated blood pressure monitor and recorded as systolic and diastolic blood pressure in millimeters of mercury (mmHg). Higher values indicate higher blood pressure. Changes from baseline were used to assess the physiological response to the dental procedure.

  4. Patient's satisfaction

    Time frame: Immediately after the procedure

    Patient satisfaction was assessed using a structured questionnaire with two yes/no questions:

    • Are you satisfied with the experience? (Yes/No)
    • Would you like to have the same technique in future visits? (Yes/No) Responses were coded as binary outcomes (Yes = 1, No = 0). Higher total scores indicated greater patient satisfaction.

Sponsors and collaborators

Lead sponsor

Latakia University

Other

Registry information

Official study title

Effects of Virtual Reality Technique on Some Vital Signs, Pain and Anxiety Scales During Dental Anaesthesia and Extraction in Children

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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