The Effect of Stellate Ganglion Block on Insomnia Patients
- Conditions
- Insomnia
- Interventions
- Procedure: Stellate Ganglion Block
- Registration Number
- NCT06255730
- Lead Sponsor
- Zeng Changhao
- Brief Summary
A prospective study was conducted on Insomnia Patients. All the patients were provided with Stellate Ganglion Block. The quality of sleep was evaluated to see if Stellate Ganglion Block can improve Insomnia.
- Detailed Description
Insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or experiencing non-restorative sleep, despite having adequate opportunity for sleep. It is a common condition that can significantly impact an individual's quality of life and overall well-being.A prospective study was conducted on Insomnia Patients. All the patients were provided with Stellate Ganglion Block. The quality of sleep was evaluated to see if Stellate Ganglion Block can improve Insomnia.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Insomnia patients with the ages over 18.
- Meeting the diagnostic criteria for chronic insomnia as per the International Classification of Sleep Disorders (ICSD) or the Diagnostic and Statistical Manual of Mental Disorders (DSM).
- Experiencing insomnia symptoms persistently for at least three months.
- Not currently using or ceased using medication for insomnia for at least four weeks.
- Willing to undergo Stellate Ganglion Block treatment and participate in the study.
- Patients with severe cardiovascular disease, pulmonary disease, or other serious physical health issues.
- Pregnant or lactating women.
- Patients with mental disorders (such as major depression, anxiety disorders, schizophrenia, etc.) or cognitive impairments.
- Patients with known allergies or contraindications to Stellate Ganglion Block treatment.
- Patients currently participating in other clinical trials or receiving experimental treatments.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stellate Ganglion Block Group Stellate Ganglion Block Stellate Ganglion Block Group will be given Stellate Ganglion Block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g), once a day Stellate Ganglion Block Group Lidocaine Hydrochloride Stellate Ganglion Block Group will be given Stellate Ganglion Block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g), once a day
- Primary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index day 1 and day 10 Pittsburgh Sleep Quality Index (PSQI): The PSQI is a widely used scale that assesses sleep quality, including aspects such as sleep latency, sleep duration, sleep efficiency, sleep disturbances, and daytime dysfunction. The total score ranges from 0 to 21, with higher scores indicating worse sleep quality.
- Secondary Outcome Measures
Name Time Method Sleep Impairment Index day 1 and day 10 Sleep Impairment Index (SII): The SII is a scale that measures the impact of sleep disorders on daily functioning. It includes nine items, covering aspects such as feeling unwell in the morning and feeling tired during the day. The total score ranges from 0 to 36, with higher scores indicating more severe sleep impairment.
Anxiety day 1 and day 10 The anxiety was assessed using the Generalized Anxiety Disorder-7, including items related to fear, worry, attention, etc. The total score ranged from 0 to 21, which was positively correlated with potential anxiety. In the previous study, the scale demonstrated a Cronbach's α-coefficient of 0.879.
Trial Locations
- Locations (1)
Center Rehabilitation Hospital
🇰🇷Seoul, Korea, Republic of