Insomnia Due to Anxiety and Fear
Conditions
Keywords
auricular acupressure, insomnia, anxiety, randomized sham controlled trial
Brief summary
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
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.
Interventions
OTHERVaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure
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.
OTHERPlain ear adhesive tape
Apply on Shenmen and Occiput without applying pressure for 5 days.
Sponsors
IMU University, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | 6th day | Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) |
| Hamilton Anxiety Rating Scale (HAM-A) | 6th day | Total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. |
Countries
Malaysia
Contacts
Primary ContactMs Tang
Outcome results
None listed