Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety

Study Overview
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Brief Summary
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This is a sham-controlled randomized trial to identify the effectiveness of treating insomnia induced by anxiety with self-administered auricular acupressure in Malaysia.

Detailed Description
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112 subjects with insomnia and anxiety who fit to the inclusion and exclusion criteria will be recruited into the trial. After initial screening, subjects will be randomly allocated to Vaccaria seed tapes (experimental arm) or non-Varracia seed plain tapes (sham comparator arm). On the sixth day for the trial (after 5 days of daily auricular acupressure), the ISI and HAM-A score of subjects will be reassessed again. The subjects have to stop applying auricular acupressure for the next five days and reassess their ISI and HAM-A score again on the eleventh day.

Official Title
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Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety: A Randomized Sham-controlled Trial

Conditions
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Insomnia Due to Anxiety and Fear

Intervention / Treatment
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* Other: Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure
* Other: Plain ear adhesive tape


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Malaysian aged above 18 years old who are suffering from chronic insomnia based on International Classification of Sleep Disorders 3(ICSD-3) and with Insomnia Severity Index (ISI) of 18 and above and more than 3 months. Willing to comply with the recommended periodic acupressure stimulation every day during the 1 week period. Exclusion Criteria: Subject with insomnia score below 18 based on Insomnia Severity Index (ISI). Subject with stress and anxiety level below 18 in the Hamilton Anxiety Rating Scale (HAM-A). Subject with the history of skin sensitivity. Subject who just started on new medication to treat insomnia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Self-administered Vaccaria seed tapes on auricular acupoints with pressure applied | Other: Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure<br>* Apply on auricular acupoints, Shenmen and Occiput, apply pressure for 3 minutes, 5 times per day, at the interval of 2   3 hours, for 5 days.<br>|
| Sham Comparator: Sham<br>Self-administered plain tapes (without Vaccaria seed) on auricular acupoints without applying pressure. | Other: Plain ear adhesive tape<br>* Apply on Shenmen and Occiput without applying pressure for 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) | 6th day | 
| Insomnia Severity Index (ISI) | Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) | 11th day | 
| Hamilton Anxiety Rating Scale (HAM-A) | Total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | 6th day | 
| Hamilton Anxiety Rating Scale (HAM-A) | Total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | 11th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, auricular acupressure, anxiety, randomized sham controlled trial