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Clinical Trials/NCT06917989
NCT06917989CompletedNot Applicable

Evaluation of the Effect of Relaxation Exercise and Virtual Reality Application on Pain, Trismus, Sleep, Kinesiophobia and Anxiety Level After Impacted Third Molar Dental Surgery

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey1 site in 1 country36 target enrollmentStarted: November 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
Dental Anxiety

Study Overview

Brief Summary

Impacted tooth extractions are the most frequently performed procedure in oral surgery. Complications such as pain and trismus are frequently observed after surgery. Pain, especially after surgery, causes serious discomfort to the individual. These complications negatively affect the daily lives of individuals. Decreased sleep quality, increased anxiety, fear of moving the jaw joint, decreased quality of life, and loss of labor are among the examples that can be given. It is important for individuals to have a more comfortable process in the early period after surgery. During this period, individuals receive pharmacological treatment; however, non-pharmacological approaches should not be ignored. Evaluation of the effects of relaxation exercise and virtual reality application applied after impacted third molar surgery on pain, trismus, sleep, kinesiophobia, and anxiety levels.

Detailed Description

Impacted third molar surgery is one of the most common procedures performed by oral, dental and maxillofacial surgeons. During surgical removal of teeth, trauma may occur due to the narrowing of the area and insufficient visibility, the position of the teeth and the hardness of the bone structure. In addition, this surgical procedure leads to various complications since it requires intraoral intervention. It has also been stated that most complications are triggered by the inflammatory process after surgery and are reported with varying frequencies. As a result of trauma that may occur in soft and bone tissue, symptoms such as pain, swelling and trismus may occur. Post-surgical pain is an acute type of pain that begins with surgical trauma, gradually decreases and ends with tissue healing. This pain triggers a stress response in the sympathetic nervous system, causing an increase in muscle tension. Another situation encountered after surgery is an increase in anxiety. Anxiety is a distinct state of restlessness caused by fear, distress or apprehension. Individuals are afraid of surgery even if they think surgery is necessary to regain their health or improve their quality of life. The incidence of complications is higher in individuals with high levels of anxiety after surgery.

In the evaluation; Modified Dental Anxiety Scale, Visual Analog Scale, Maximum Active Mouth Opening Measurement, The Tampa Scale for Kinesiophobia for Temporomandibular Disorders, Electromyography (EMG), Turkish version of the Visual Analog Sleep Scale, State and Trait Anxiety Scale will be used.

Individuals participating in the study will be included in one of 3 groups. Group 1 will be Relaxation Exercise, Group 2 will be Virtual Reality Application in addition to Relaxation Exercise, and Group 3 will be the control group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Being between the ages of 18-35
  • •According to the Pell and Gregory classification; Having undergone surgery on a mandibular third molar with Class 2-3, Position B and C impaction degree
  • •Being systemically healthy (ASA 1)
  • •Not having high dental anxiety according to the Modified Dental Anxiety Scale (<19)
  • •Individuals who have undergone bone removal during surgery
  • •Individuals who do not have any psychiatric problems
  • •Presence of pain <3 months

Exclusion Criteria

  • •Presence of myofascial pain affecting the temporomandibular joint
  • •Presence of tumoral structure related to the impacted third molar
  • •Presence of acute pericoronitis
  • •Presence of bruxism
  • •Presence of vertigo, seizures, epilepsy, active nausea and vomiting
  • •Having a beard but not preferring to shave (shaved skin is required for accurate EMG measurement)
  • •Pregnancy
  • •Smoking and alcohol addiction
  • •Individuals with sleep disorders

Arms & Interventions

Relaxation Exercise

Experimental

Consist of participants who underwent Relaxation Exercise and Patient Education

Intervention: Relaxation Exercise (Other)

Relaxation Exercise

Experimental

Consist of participants who underwent Relaxation Exercise and Patient Education

Intervention: Patient Education (Other)

Virtual Reality Application in Addition to the Relaxation Exercise

Experimental

Consist of participants who underwent Relaxation Exercise and Virtual Reality Application and Patient Education

Intervention: Patient Education (Other)

Virtual Reality Application in Addition to the Relaxation Exercise

Experimental

Consist of participants who underwent Relaxation Exercise and Virtual Reality Application and Patient Education

Intervention: Relaxation Exercise (Other)

Virtual Reality Application in Addition to the Relaxation Exercise

Experimental

Consist of participants who underwent Relaxation Exercise and Virtual Reality Application and Patient Education

Intervention: Virtual Reality Application (Other)

Control Group

Other

Consist of participants who underwent Patient Education

Intervention: Patient Education (Other)

Outcomes

Primary Outcomes

Dental Anxiety

Time Frame: Before impacted third molar extraction

Modified Dental Anxiety Scale: The lowest total score to be received on the entire survey is 5, the highest score is 25. A high score denoted a high anxiety response.

Pain Level

Time Frame: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day

Visual Analog Scale: At the left end of the scale (0 cm) is "no pain"; at the right end (10 cm) is "worst pain". (0: no pain, 10: unbearable pain). The higher the score, the higher the pain level.

Maximum Active Mouth Opening

Time Frame: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day

Therabite Range of Motion Scale: According to the measurement results made with the ruler, the value obtained will increase as the mouth opening distance increases.

Kinesiophobia Level

Time Frame: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day

The Tampa Scale for Kinesiophobia for Temporomandibular Disorders: 12-48 points are received on this scale. The higher the score the person receives, the higher the level of kinesiophobia

Muscle Activity

Time Frame: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day

Electromyography

Sleep Quality

Time Frame: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day

Turkish version of the Visual Analog Sleep Scale: The scale is scored between 0 and 1000. The higher the score received from the scale indicates that the quality of sleep has decreased.

Anxiety Level

Time Frame: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day

State-Trait Anxiety Inventory: The highest score is 80, the lowest score is 20. The higher the total anxiety score, the higher the anxiety level of the person filling out the scale.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Emre Serdar Atalay

Assistant Professor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Study Sites (1)

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