Evaluation of the Effect of Relaxation Exercise and Virtual Reality Application After Impacted Third Molar Dental Surgery

NCT06917989 | Completed

• 2 other identifiers: 2024/001Academician
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Relaxation; Third Molar Surgery; Pain

Keywords

Virtual Reality; Relaxation; Third Molar Surgery; Pain

Outcome Measures

Primary Outcomes (7)

• Dental Anxiety

  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.

  Before impacted third molar extraction

• Pain Level

  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.

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

• Maximum Active Mouth Opening

  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.

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

• Kinesiophobia Level

  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

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

• Muscle Activity

  Electromyography

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

• Sleep Quality

  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.

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

• Anxiety Level

  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.

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

Study Arms (3)

Relaxation Exercise

EXPERIMENTAL

Consist of participants who underwent Relaxation Exercise and Patient Education

Other: Relaxation Exercise; Other: Patient Education

Virtual Reality Application in Addition to the Relaxation Exercise

EXPERIMENTAL

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

Other: Relaxation Exercise; Other: Virtual Reality Application; Other: Patient Education

Control Group

OTHER

Consist of participants who underwent Patient Education

Other: Patient Education

Interventions

Virtual Reality Application OTHER

Virtual Reality Application will be done using virtual reality glasses

Virtual Reality Application in Addition to the Relaxation Exercise

Patient Education OTHER

Participants will be informed about oral care, food consumption, nutrition and sleeping position.

Control Group; Relaxation Exercise; Virtual Reality Application in Addition to the Relaxation Exercise

Relaxation Exercise OTHER

Jacobson muscle relaxation technique

Relaxation Exercise; Virtual Reality Application in Addition to the Relaxation Exercise

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: collaborator
• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

University of Health Sciences

Ankara, Kecioren, 06610, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 31555379 BACKGROUND

• 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.

  PMID: 33874974 BACKGROUND

• 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.

  PMID: 34097862 BACKGROUND

• 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.

  PMID: 22341136 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 9, 2025
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

TU (1)