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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Self-administered Vaccaria seed tapes on auricular acupoints with pressure applied |
|
| Sham | Sham Comparator | Self-administered plain tapes (without Vaccaria seed) on auricular acupoints without applying pressure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure | Other | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ms Tang | Contact | 03-27317202 | freyatang@imu.edu.my |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Medical University (IMU) | Recruiting | Kuala Lumpur | Malaysia |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 10, 2023 | |
| Reset | Dec 13, 2023 |
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| Plain ear adhesive tape | Other | Apply on Shenmen and Occiput without applying pressure for 5 days. |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 10, 2023 | Dec 13, 2023 |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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