Clinical trial NCT06917989: Evaluation of the Effect of Relaxation Exercise and Virtual Reality Application After Impacted Third Molar Dental Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Virtual Reality
Relaxation
Third Molar Surgery
Pain
Keywords: Virtual Reality
Relaxation
Third Molar Surgery
Pain
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
Collaborators: name: Saglik Bilimleri Universitesi
First posted: 2025-04-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 will be given a Relaxation Exercise, Group 2 will be given a Virtual Reality Application in Addition to the Relaxation Exercise. Group 3 will be the control group. Patient education will be given to all groups as Group 1, Group 2 and Group 3. Participants will be between the ages of 18-35.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dental Anxiety
timeFrame: Before impacted third molar extraction
measure: Pain Level
timeFrame: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
measure: Maximum Active Mouth Opening
timeFrame: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
measure: Kinesiophobia Level
timeFrame: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
measure: Muscle Activity
timeFrame: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
measure: Sleep Quality
timeFrame: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
measure: Anxiety Level
timeFrame: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences
state: Kecioren
Study officials:
References:
citation: Ju W, Ren L, Chen J, Du Y. Efficacy of relaxation therapy as an effective nursing intervention for post-operative pain relief in patients undergoing abdominal surgery: A systematic review and meta-analysis. Exp Ther Med. 2019 Oct;18(4):2909-2916. doi: 10.3892/etm.2019.7915. Epub 2019 Aug 19.
citation: Georgescu RD, Dobrean A, Silaghi CA, Silaghi H. A virtual reality-based intervention for surgical patients: study protocol of a randomized controlled trial. Trials. 2021 Apr 19;22(1):289. doi: 10.1186/s13063-021-05196-7.
citation: Gurram P, Narayanan V, Chandran S, Ramakrishnan K, Subramanian A, Kalakumari AP. Effect of Heartfulness Meditation on Anxiety and Perceived Pain in Patients Undergoing Impacted Third Molar Surgery. J Oral Maxillofac Surg. 2021 Oct;79(10):2060.e1-2060.e7. doi: 10.1016/j.joms.2021.04.027. Epub 2021 Apr 29.
citation: Topcu SY, Findik UY. Effect of relaxation exercises on controlling postoperative pain. Pain Manag Nurs. 2012 Mar;13(1):11-7. doi: 10.1016/j.pmn.2010.07.006. Epub 2010 Sep 21.