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OpenTrials
Completed

NCT Number: NCT06092177

Virtual Reality Distraction in Patients Undergoing Periodontal Surgery

The goal of this randomized controlled clinical trial is to evaluate the effect of virtual reality technology on anxiety and pain levels in patients undergoing periodontal surgery.

Participants will be randomly assigned into test and control groups. While the patients in the test group will undergo periodontal surgery with virtual reality distraction, the patients in the control group without distraction. After treatment, the groups will be compared regarding anxiety and pain levels.

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Key information

Conditions

Virtual Reality Dental Anxiety Oral Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individuals over the age of 18
  • Systemically healthy patients
  • Need for periodontal surgical treatment in the mandibular anterior region
  • Scoring 15 or above on the modified dental anxiety scale

Exclusion criteria

  • Having a history of seizures or a convulsive disorder
  • Balance disorders such as nystagmus, vertigo
  • Use of psychotropic drugs
  • Getting treatment for anxiety
  • Presence of dermatological lesions on the face, especially around the eyes
  • A lesion in the eye that will prevent the use of virtual reality glasses
  • Systemic disease and medication use that contraindicate periodontal surgery

Treatment and study plan

Periodontal surgery with virtual reality distraction

Procedure

Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets

Periodontal surgery without virtual reality distraction

Procedure

Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets

Primary outcomes

  1. Anxiety level

    Time frame: Preoperative, immediately postoperative

    Modified dental anxiety scale where higher scores mean a worse outcome and has a minimum value of 5 and a maximum value of 25

Secondary outcomes

  1. Pain level

    Time frame: Preoperative, immediately postoperative

    Visual analog scale where higher scores mean a worse outcome and has a minimum value of 0 and a maximum value of 10

  2. Systolic blood pressure

    Time frame: Preoperative, intraoperative, immediately postoperative

    Blood pressure will be measured by a sphygmomanometer.

  3. Diastolic blood pressure

    Time frame: Preoperative, intraoperative, immediately postoperative

    Blood pressure will be measured by a sphygmomanometer.

  4. Heart rate

    Time frame: Preoperative, intraoperative, immediately postoperative

    The frequency of the heartbeat measured by the number of contractions of the heart per minute

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Evaluation of Virtual Reality Distraction on Dental Anxiety in Patients Undergoing Periodontal Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

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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