- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06917989
Evaluation of the Effect of Relaxation Exercise and Virtual Reality Application After Impacted Third Molar Dental Surgery
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kecioren
-
Ankara, Kecioren, Turkey (Türkiye), 06610
- University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Relaxation Exercise
Consist of participants who underwent Relaxation Exercise and Patient Education
|
Jacobson muscle relaxation technique
Participants will be informed about oral care, food consumption, nutrition and sleeping position.
|
|
Experimental: Virtual Reality Application in Addition to the Relaxation Exercise
Consist of participants who underwent Relaxation Exercise and Virtual Reality Application and Patient Education
|
Jacobson muscle relaxation technique
Participants will be informed about oral care, food consumption, nutrition and sleeping position.
Virtual Reality Application will be done using virtual reality glasses
|
|
Other: Control Group
Consist of participants who underwent Patient Education
|
Participants will be informed about oral care, food consumption, nutrition and sleeping position.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Before impacted third molar extraction
|
|
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.
|
Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
|
|
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.
|
Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
|
|
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
|
Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
|
|
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
|
Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
|
|
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.
|
Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
|
|
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.
|
Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/001
- Academician (Other Identifier: University of Health Sciences Turkiye)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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