Insomnia
Conditions
Interventions
Trial Group:CBT-I (Cognitive Behavioral Therapy) + Five-Note Imagery Hypnosis Technique (Hospital Intervention: Lying position listening to Yu-tone music 'Purifying Water', Chinese herbal aroma, image
Home Intervention: Listening to Yu-tone music 'Purifying Water' before sleep, imagery guidance), 5 times per week for 4 consecutive weeks
Control Group:CBT-I (Cognitive Behavioral Therapy, including sleep hygiene education, stimulus control therapy, sleep restriction therapy, relaxation training, cognitive therapy), once per week, 30-60
Sponsors
The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet the above diagnostic criteria of both traditional Chinese medicine and Western medicine; 2. Be aged between 40 and 70 years, inclusive; 3. Have not received any traditional Chinese medicine or Western medicine treatment for insomnia within the past month; 4. Have a total Pittsburgh Sleep Quality Index (PSQI) score >= 7, and an Insomnia Severity Index (ISI) score between 8 and 21, indicating mild to moderate insomnia; 5. Possess the ability to read, write, and communicate, and be able to cooperate with the physician; 6. Voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with severe or decompensated systemic diseases, such as heart, liver, or kidney diseases; 2. Individuals with long-term alcohol use, drug dependence, or mental disorders; 3. Pregnant or lactating women; 4. Individuals who have received insomnia-related treatment within 30 days before screening, including sedative-hypnotic medications, CBT-I, or other traditional Chinese medicine characteristic interventions for insomnia; 5. Individuals with nasal trauma or diseases that affect olfactory function; 6. Individuals with deafness or hearing impairment that affects auditory function; 7. Individuals with obvious cognitive impairment, or those who are unable to understand the study content or cooperate with CBT-I intervention, scale assessments, and follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Memorial University of Newfoundland Scale of Happiness (MUNSH);Insomnia Severity Index (ISI);Fear of Progression Questionnaire-Short Form (FoP-Q-SF);Security Questionnaire (SQ);TCM Syndrome Score;Heart rate variablity; | — |
Countries
China
Contacts
Public ContactZhou Xia
The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed