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临床试验/NCT04775758
NCT04775758Unknown不适用

Atypical Orofacial Pain Diagnostics and Differentiation.

Lithuanian University of Health Sciences1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年2月27日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Visual analog scale

研究概览

简要总结

Orofacial pain is diagnosed for more than 1.9 percent of general population and for 0.3 percent origin of the facial pain is unknown. Commonly atypical facial pain is treated as a neurological condition without an emotional or psychiatric evaluation. Since atypical pain and mood affective disorders can be related, patients do not receive proper care for this condition.

The aim of this study is to evaluate the relationship between atypical facial pain syndrome and affective mood disorders. We aim to assess patients' with no diagnosed organic pathology tendency towards anxiety, depression, sleep disorders and one of big five personality traits through self-rating questionnaires. We will compare the gathered data with biosensors from iMotions software.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Visual analog scale

时间窗: Assessment score gathered once (Day 1)

Patients evaluate their spontaneous episodic pain before assessing self-evaluating questionnaires. Patient pain will be assessed using a visual analogue scale of 0-10, zero being no pain, ten being an unbearable/unimaginable pain. The higher score may lead to a possibilty of developing mood disorders.

Hospital anxiety and depression scale

时间窗: Assessment score gathered once (Day 1)

The Hospital anxiety and depression scale is a fourteen-item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.

Pittsburgh sleep quality index

时间窗: Assessment score gathered once (Day 1)

The Pittsburgh Sleep Quality Index contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).

Big Five personality traits

时间窗: Assessment score gathered once (Day 1)

Big five personality traits questionnaire is a 25-item questionnaire compiled from Goldberg et al. 1999. Respondent chooses between a pair of adjectives and chooses an according score from one to seven. All personality dimensions are evaluated separately from specific pairs of adjectives and sum of these pairs scores. Lithuanian version is adapted from A.Bunevičius (2006).

Galvanic skin response. Valence

时间窗: Assessment score gathered once (Day 1)

Galvanic skin response peaks (countable) either total or within positive, negative and neutral condition valence.

Galvanic skin response. Amplitude

时间窗: Assessment score gathered once (Day 1)

Galvanic skin response is measured in microsiemens. Sudden rise in skin conductivity is called a peak. Peak amplitudes (in microsiemens) will be recorded and analysed. Average amplitude of peaks, either total or within positive, negative and neutral valence.

Galvanic skin response. Peaks/minute

时间窗: Assessment score gathered once (Day 1)

Peaks/minute (normalized measure) either total or within positive, negative and neutral valence.

Facial expression analysis. Duration of positive valence.

时间窗: Assessment score gathered once (Day 1)

Facial expression analysis determines the respondents' valence (negative, positive or neutral). The duration of positive valence (more than 30 percent threshold) will be assessed seconds.

Facial expression analysis. Duration of negative valence.

时间窗: Assessment score gathered once (Day 1)

Facial expression analysis determines the respondents' valence (negative, positive or neutral), the duration of negative valence (less than 30 percent threshold) will be assessed in seconds.

Facial expression analysis. Duration of neutral valence.

时间窗: Assessment score gathered once (Day 1)

Facial expression analysis determines the respondents' valence (negative, positive or neutral). The duration of neutral valence (from -30 percent to 30 percent threshold) will be assessed in seconds.

Facial expression analysis. Total duration.

时间窗: Assessment score gathered once (Day 1)

Facial expression analysis determines the respondents' valence (negative, positive or neutral). A total duration of the record (measuring time in seconds) will be used.

次要结局

  • Heart rate(Assessment score gathered once (Day 1))
  • Facial expression analysis (raw data)(Assessment score gathered once (Day 1))
  • Facial expression analysis threshold(Assessment score gathered once (Day 1))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan Pavel Rokicki

Administrator in Lithuanian University of Health Sciences Kaunas Clinics, Dentist, Oral Surgeon

Lithuanian University of Health Sciences

研究点 (1)

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