Thyroid Related Eye Disease Clinical Trial
Official title:
Psychological Status and Related Factors of Thyroid Related Eye Disease
| NCT number | NCT03426696 |
| Other study ID # | 201701 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 1, 2017 |
| Est. completion date | December 31, 2018 |
| Verified date | May 2020 |
| Source | Sun Yat-sen University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to evaluate the psychological status of Thyroid Related Eye Disease.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | December 31, 2018 |
| Est. primary completion date | December 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility |
Inclusion Criteria: - over 16 years old - diagnosed as Thyroid Related Eye Disease Exclusion Criteria: - any uncontrolled clinical problems |
| Country | Name | City | State |
|---|---|---|---|
| China | Sun Yat-sen University | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Huijing Ye |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quality of life questionnaire of patients of Thyroid Related Eye Disease | Graves ยด ophthalmopathy quality of life questionnaire (GO-QoL) , The GO-QoL contains 8 questions on visual functioning and 8 questions on appearance; answers on each subscale are transformed to scores ranging from 0 (worst) to 100 (best). | immediately | |
| Secondary | Symptom checklist 90(SLC-90) | It consists of 90 items yielding nine scores along primary symptom dimensions and three scores among global distress indices. The primary symptom dimensions that are assessed are somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and a category of "additional items" which helps clinicians assess other aspect of the clients symptoms. Positive standard includes: total score 160 points or more, or positive items > 43 points, or any item > 2 points. | immediately | |
| Secondary | Hamilton anxiety scale(HAMA) | This scale includes 14 items. All projects rated as: asymptomatic, light, medium, heavy, or very heavy. If the total score more than 29 points, there could be severe anxiety; more than 21 points, affirmation have obvious anxiety; more than 14 points, there must be some anxious; more than 7 points might be anxious; if less than 6 points, patients without anxiety symptoms. | immediately | |
| Secondary | Somatic self-rating scale(SSS) | Somatic self-rating scale can let the doctor fully understand patients' mood and somatization symptoms. If the selected items scores more than 30 points, the patient may need to clinic treatment. | immediately | |
| Secondary | Hamilton depression scale(HAMD) | It is the most common depression clinical application scale. Lower score presents lighter condition, and if the illness is heavier, the higher is the score. There is no depression symptoms for score less than eight points. | immediately | |
| Secondary | Young manic rating scale(YMRS) | The Young Mania Rating Scale (YMRS) is a diagnostic questionnaire commonly used to evaluate manic symptoms in patients with bipolar 1 disorder and to assess treatment efficacy in clinical trials. This rating scale comprises eleven items (elevated mood, increased motor activity - energy, sexual interest, sleep, irritability, speech - rate and amount, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight). The total YMRS score is calculated as the summation of each of the eleven individual item scores.Lower score presents lighter condition, and if the illness is heavier, the higher is the score.There is no manic symptoms for score less than five points. | immediately |