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

International Medical University

Status: Unknown

Conditions: Insomnia Due to Anxiety and Fear

Treatments: Other: Plain ear adhesive tape; Other: Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure

Study type: Interventional

Funder types: Other

Identifiers

NCT05152095

BCM I-2021 (04)

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups

Intervention

Experimental group

Description:

Self-administered Vaccaria seed tapes on auricular acupoints with pressure applied

Treatment:

Other: Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure

Sham

Sham Comparator group

Description:

Self-administered plain tapes (without Vaccaria seed) on auricular acupoints without applying pressure.

Treatment:

Other: Plain ear adhesive tape