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| ID | Type | Description | Link |
|---|---|---|---|
| N-20250034 | Other Identifier | The North Denmark Region Committee on Health Research Ethics |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Hygiene Education | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Hygiene Education | Behavioral | The intervention consists of a structured and standardized sleep hygiene education program delivered in a single in-person session. Participants receive verbal instruction and written materials outlining evidence-based recommendations for improving sleep habits. The content focuses on establishing consistent bedtimes and wake times, creating a good sleep environment, reducing evening exposure to stimulants and electronic devices, developing calming nighttime routines, and adopting healthy daytime behaviors. Participants implement these strategies independently for four weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Quality (PSQI Global Score) | 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. | Baseline (Visit 1) to 4 weeks (Visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Hygiene Behaviors (Sleep Hygiene Index, SHI) | Sleep hygiene behaviors are measured using the Sleep Hygiene Index (SHI), which assesses engagement in behaviors that negatively impact sleep. Higher scores reflect poorer sleep hygiene. Changes across time points will be assessed. | Baseline (Visit 1) to 4 weeks (Visit 2); Week 1; Week 2; Week 3; 3-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristian Kjær-Staal Petersen | Contact | +45 31697510 | kkp@hst.aau.dk | |
| Emma Hertel | Contact | eh@hst.aau.dk |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| D012893 | Sleep Wake Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000070263 | Sleep Hygiene |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Change in Temporal Summation of Pain (Pinprick Sensitivity Test) | Temporal summation is assessed using a standardized pinprick protocol on the volar forearm. Participants provide pain ratings for a single stimulus and for the last of 10 consecutive stimuli. The outcome is the change in temporal summation response. | Baseline (Visit 1) to 4 weeks (Visit 2) |
| Change in PainDetect | PainDetect assesses neuropathic and centrally mediated pain components. Higher scores indicate a higher likelihood of central sensitization. | Baseline (Visit 1) to 4 weeks (Visit 2) |
| Change in Headache Impact (HIT-6) - for migraine participants only | The HIT-6 assesses the functional impact of headaches. Higher scores indicate greater impairment. | Baseline (Visit 1) to 4 weeks (Visit 2) |
| Long-Term Maintenance of Sleep Hygiene Index, SHI | Assessed via an online questionnaire evaluating whether changes in SHI scores persist three months after the intervention period. Higher scores reflect poorer sleep hygiene adherence. | 4 weeks (Visit 2) to 3-month post-intervention follow-up (remote) |
| Long-Term Maintenance of PSQI | Assessed via an online questionnaire evaluating whether changes in PSQI persist three months after the intervention period. Higher scores indicate poorer quality of sleep. | 4 weeks (Visit 2) to 3-month post-intervention follow-up (remote) |
| Long-Term Pain Intensity Measure - PainDetect | Assessed via an online questionnaire evaluating whether changes in PainDetect scores persist three months after the intervention period. Higher scores indicate a higher likelihood of central sensitization. | 4 weeks (Visit 2) to 3-month post-intervention follow-up (remote) |
| Long-Term Maintenance of Headache Impact (HIT-6) - for migraine participants only | Assessed via an online questionnaire evaluating whether changes in HIT-6 persist three months after the intervention period. Higher scores indicate greater impairment. | 4 weeks (Visit 2) to 3-month post-intervention follow-up (remote) |
| D009422 | Nervous System Diseases |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D015438 | Health Behavior |
| D001519 | Behavior |