Emotional behavior problems in children with chronic insomnia
Conditions
Interventions
Treatment Group:Chinese medicine Qianyang Anshen prescription + behavior therapy
Control group:Chinese medicine placebo + behavioral therapy
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
7 Years to 12 Years
Inclusion criteria
Inclusion criteria: (1) Age 7-12 years old, male or female; (2) meet the diagnostic criteria of chronic insomnia disorder in Western medicine; (Article (4) and (6) of Item B in the diagnostic criteria of Western Medicine) (4. Emotional instability/irritability; 6. Behavioral problems (e.g. hyperactivity, impulsivity, aggressive behavior). (3) In line with the TCM sleepless - heart and liver fire syndrome differentiation standards; (4) Parents assessed the child's insomnia status as moderate/severe; (5) Patients who voluntarily accept and can cooperate with the completion of data collection; (6) Sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Insomnia caused by physical discomfort: such as cough, wheezing, pain, itching, etc.; (2) Use drugs known to alter sleep (such as melatonin, sleeping pills, psychotropic drugs, etc.). (3) accompanied by serious liver and kidney diseases, nervous system diseases, cardiovascular diseases, endocrine diseases, blood system diseases; (4) Allergic to the experimental drug; (5) According to the judgment of the doctor, it is easy to cause loss of visitors; (6) those who are using other drugs due to chronic diseases; (7) Insomnia caused by serious mental disorders such as depression, anxiety disorder, bipolar disorder, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree to which the primary caregiver assessed the child's insomnia disorder; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change value of emotional instability factor score of emotional disorder;Changes of brain functional emotion recognition task related indicators;Changes in the score of the Screening Scale for anxious mood disorders in children;Sleep latency wake times/wake times;Strengths and difficulties questionnaire score changes;Children depression scale score change value; | — |
Countries
China
Contacts
Public ContactJiang Yonghong
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed