Kan Uddannelse i søvnhygiejne Forbedre søvnkvalitet for Patienter Med Kroniske Smerter?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change in Sleep Quality (PSQI Global Score)
研究概览
简要总结
The goal of this clinical trial is to learn whether sleep hygiene education can improve sleep quality and reduce pain in adults with migraine and/or chronic lower back pain. Poor sleep is common in people with chronic pain and may worsen symptoms. Improving sleep may help break this cycle.
The main questions this study aims to answer are:
- Does a four-week sleep hygiene education program improve sleep quality?
- Does improved sleep lead to reduced pain intensity and changes in pain sensitivity?
This study does not include a comparison group. Each participant serves as their own comparison by completing the same tests before and after the sleep hygiene program.
Participants will:
- Attend two study visits lasting 30-60 minutes, one at the beginning and one after four weeks
- Complete questionnaires about sleep, pain, mood, and quality of life at both visits
- Undergo pain sensitivity testing using light pinprick stimulations on the forearm
- Receive individual sleep hygiene education and written materials to use at home for four weeks
- Complete a short weekly online check-in about sleep habits and pain
- Complete a three-month follow-up questionnaire about sleep habits, sleep quality, and pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic back pain (average pain VAS ≥ 3) AND/OR Migraine (migraine or tension headaches ≥15 days per month with ≥8 days being migraine)
- •Lasting ≥3 months
- •Adults ≥18 years old
- •Read, speak, and understand Danish
- •Willing to implement sleep hygiene for four weeks
- •Digital competencies (sufficient to answer questionnaires online)
排除标准
- •Pregnancy
- •Drug addiction, defined as the use of cannabis, opioids, or other drugs
- •Malignant comorbidity (e.g., cancer)
- •Neurological conditions affecting cognition (e.g., multiple sclerosis, epilepsy, dementia, previous stroke/transient cerebral ischemia)
- •Intake of acute headache medication on ≥15 days/month for simple analgesics/NSAIDs or ≥10 days/month for triptans, ergotamine, opioids, or combinations thereof over 3 months.
- •Use of unstable sleep-modulating pharmacological treatment (e.g., melatonin, tricyclic antidepressants)
- •Diagnosed sleep disorder (e.g., insomnia, narcolepsy, sleep apnoea)
- •Night-shift work
- •Initiation of any new therapy during the study period
- •The subject is assessed as unable to engage in the necessary cooperation required by the study
研究组 & 干预措施
Sleep Hygiene Education
Participants receive a structured sleep hygiene education program during the first study visit, including verbal instructions and written materials covering consistent sleep routines, sleep environment optimization, evening habits, and reduction of stimulants and screen use. Participants are asked to apply the recommendations in daily life for four weeks and complete weekly online check-ins. At the second visit, they repeat questionnaires and sensory testing to evaluate changes from baseline.
干预措施: Sleep Hygiene Education (Behavioral)
结局指标
主要结局
Change in Sleep Quality (PSQI Global Score)
时间窗: Baseline (Visit 1) to 4 weeks (Visit 2)
Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire summarized into a global sleep quality score (0-21). Higher scores indicate poorer sleep quality. The primary outcome is the change in PSQI global score after four weeks of sleep hygiene education.
次要结局
- Change in Sleep Hygiene Behaviors (Sleep Hygiene Index, SHI)(Baseline (Visit 1) to 4 weeks (Visit 2); Week 1; Week 2; Week 3; 3-month follow-up)
- Change in Temporal Summation of Pain (Pinprick Sensitivity Test)(Baseline (Visit 1) to 4 weeks (Visit 2))
- Change in PainDetect(Baseline (Visit 1) to 4 weeks (Visit 2))
- Change in Headache Impact (HIT-6) - for migraine participants only(Baseline (Visit 1) to 4 weeks (Visit 2))
- Long-Term Maintenance of Sleep Hygiene Index, SHI(4 weeks (Visit 2) to 3-month post-intervention follow-up (remote))
- Long-Term Maintenance of PSQI(4 weeks (Visit 2) to 3-month post-intervention follow-up (remote))
- Long-Term Pain Intensity Measure - PainDetect(4 weeks (Visit 2) to 3-month post-intervention follow-up (remote))
- Long-Term Maintenance of Headache Impact (HIT-6) - for migraine participants only(4 weeks (Visit 2) to 3-month post-intervention follow-up (remote))
研究者
Kristian Kjær Petersen
Associate Professor
Aalborg University