NCT04775758|UnknownDMC
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Sponsor study identifier
interventional
150
1 country
1
Study Start
February 27, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 22, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2021
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 21, 2021
Actual (reported)February 27, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2021
Actual (reported)July 22, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Visual analog scale
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.
Assessment score gathered once (Day 1)
Hospital anxiety and depression scale
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.
Assessment score gathered once (Day 1)
Pittsburgh sleep quality index
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).
Assessment score gathered once (Day 1)
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)
Patients with clinally diagnosed G50.1 - atypical pain condition after all necessary diagnostic measures are taken to exclude a clear organic pathology (multiple diagnostic tests including MRI, CT and consultations from other specialists). Patients included in this study will undergo self-evaluating questionnaires and objective data analysis with facial expression analysis, galvanic skin response and heart rate. All tests are performed in one visit which will last up to an hour.
Patients with maxillofacial fracture (S02.3, S02.4, S02.6.) will be subjected into control group. Patients included in this study will undergo self-evaluating questionnaires and objective data analysis with facial expression analysis, galvanic skin response and heart rate. All tests are performed in one visit which will last up to an hour.
Patients are asked to describe their disease (gathering of anamnesis) and to categorize their symptoms according to their strength. Furthermore, patients complete self-evaluating questionnaires: Visual analog scale, Hospital anxiety and depression scale, Pittsburgh sleep quality index, Big five personality traits questionnaire.
Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania
First Submitted
February 21, 2021
First Posted
March 1, 2021
Study Start
February 27, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Big Five personality traits
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).
Assessment score gathered once (Day 1)
Galvanic skin response. Valence
Galvanic skin response peaks (countable) either total or within positive, negative and neutral condition valence.
Assessment score gathered once (Day 1)
Galvanic skin response. Amplitude
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.
Assessment score gathered once (Day 1)
Galvanic skin response. Peaks/minute
Peaks/minute (normalized measure) either total or within positive, negative and neutral valence.
Assessment score gathered once (Day 1)
Facial expression analysis. Duration of positive valence.
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.
Assessment score gathered once (Day 1)
Facial expression analysis. Duration of negative valence.
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.
Assessment score gathered once (Day 1)
Facial expression analysis. Duration of neutral valence.
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.
Assessment score gathered once (Day 1)
Facial expression analysis. Total duration.
Facial expression analysis determines the respondents' valence (negative, positive or neutral). A total duration of the record (measuring time in seconds) will be used.
Assessment score gathered once (Day 1)
While patients' anamnesis and questionnaire indexes are being gathered, iMotions software will gather facial expression analysis, galvanic skin response and heart rate data which will be compared with self-evaluating questionnaires.
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July 22, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 1, 2021
Record last verified: 2021-02
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