Virtual RealityNCT06917989
Evaluation of the Effect of Relaxation Exercise and Virtual Reality Application After Impacted Third Molar Dental Surgery
A study testing Relaxation Exercise, Virtual Reality Application and Patient Education in people with Virtual Reality and Relaxation, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Relaxation, Third Molar Surgery
- What is being tested?
- Relaxation Exercise, Virtual Reality Application and Patient Education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Pregnancy
- Smoking and alcohol addiction
- Individuals with sleep disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Ankara, Kecioren, 06610
About this study
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
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.
Read the 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.
- Conditions
- Virtual Reality, Relaxation, Third Molar Surgery, Pain
- Being tested
- Relaxation Exercise, Virtual Reality Application, Patient Education
- Keywords
- Virtual Reality, Relaxation, Third Molar Surgery, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation ExerciseOther
Jacobson muscle relaxation technique
Virtual Reality ApplicationOther
Virtual Reality Application will be done using virtual reality glasses
Patient EducationOther
Participants will be informed about oral care, food consumption, nutrition and sleeping position.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation Exercise | Experimental | Consist of participants who underwent Relaxation Exercise and Patient Education Receives: 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 Receives: Other: Relaxation Exercise; Other: Virtual Reality Application; Other: Patient Education |
| Control Group | Other | Consist of participants who underwent Patient Education Receives: Other: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
Muscle Activity
Electromyography
Measured: 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.
Measured: 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.
Measured: Before the impacted third molar extraction - within 30 minutes after impacted third molar extraction - post-operative 2nd and 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Nov 2024
- Primary completion1 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Emre Serdar Atalay, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917989
- Sponsor's protocol ID
- 2024/001
- Other IDs
- Academician
- Status last verified
- Feb 2026
- First submitted
- 28 Mar 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31555379Georgescu 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.
PubMed 33874974Gurram 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.
PubMed 34097862Topcu 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.
PubMed 22341136Kilinc Ozay B, Atalay ES, Samur Erguven S, Ozkan A, Akkoyun Sert O, Un Yildirim N. How Virtual Reality and Relaxation Exercises Shape Pain, Sleep, Kinesiophobia and Anxiety Over Time After Impacted Third Molar Surgery?: A Randomized Controlled Study. J Oral Rehabil. 2026 Oct 2. doi: 10.1111/joor.70324. Online ahead of print.
PubMed 42827315
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06917989
- Acronym / sponsor ID
- 2024/001
- Conditions
- Virtual Reality, Relaxation, Third Molar Surgery, Pain
- Keywords
- Virtual Reality, Relaxation, Third Molar Surgery, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Relaxation Exercise | Experimental | Other: Relaxation Exercise, Other: Patient EducationConsist of participants who underwent Relaxation Exercise and Patient Education |
| Virtual Reality Application in Addition to the Relaxation Exercise | Experimental | Other: Relaxation Exercise, Other: Virtual Reality Application, Other: Patient EducationConsist of participants who underwent Relaxation Exercise and Virtual Reality Application and Patient Education |
| Control Group | Other | Other: Patient EducationConsist of participants who underwent Patient Education |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation ExerciseJacobson muscle relaxation technique | Other | Relaxation Exercise, Virtual Reality Application in Addition to the Relaxation Exercise |
| Virtual Reality ApplicationVirtual Reality Application will be done using virtual reality glasses | Other | Virtual Reality Application in Addition to the Relaxation Exercise |
| Patient EducationParticipants will be informed about oral care, food consumption, nutrition and sleeping position. | Other | Control Group, Relaxation Exercise, Virtual Reality Application in Addition to the Relaxation Exercise |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 31555379Ju 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.
- Background: PubMed 33874974Georgescu 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.
- Background: PubMed 34097862Gurram 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.
- Background: PubMed 22341136Topcu 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.
- Derived from this study: PubMed 42827315Kilinc Ozay B, Atalay ES, Samur Erguven S, Ozkan A, Akkoyun Sert O, Un Yildirim N. How Virtual Reality and Relaxation Exercises Shape Pain, Sleep, Kinesiophobia and Anxiety Over Time After Impacted Third Molar Surgery?: A Randomized Controlled Study. J Oral Rehabil. 2026 Oct 2. doi: 10.1111/joor.70324. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Exercise, Virtual Reality Application and Patient Education in people with Virtual Reality and Relaxation, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Anxiety (time frame: Before impacted third molar extraction). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06917989, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.