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

N/AUnknownNCT05152095

IMU University, Malaysia112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

112

Conditions

Insomnia Due to Anxiety and Fear

Interventions

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

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.

Plain ear adhesive tapeOTHER

Apply on Shenmen and Occiput without applying pressure for 5 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

International Medical University (IMU)

Kuala Lumpur, Malaysia

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: 11th day

Central Contacts

Ms Tang

CONTACT

03-27317202 freyatang@imu.edu.my

Data from ClinicalTrials.gov

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