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临床试验/NCT06917989
NCT06917989已完成不适用

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 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Dental Anxiety

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Relaxation Exercise

Experimental

Consist of participants who underwent Relaxation Exercise and Patient Education

干预措施: Relaxation Exercise (Other)

Relaxation Exercise

Experimental

Consist of participants who underwent Relaxation Exercise and Patient Education

干预措施: 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

干预措施: 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

干预措施: 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

干预措施: Virtual Reality Application (Other)

Control Group

Other

Consist of participants who underwent Patient Education

干预措施: Patient Education (Other)

结局指标

主要结局

Dental Anxiety

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

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

Electromyography

Sleep Quality

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emre Serdar Atalay

Assistant Professor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

研究点 (1)

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