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

Not Applicable

• Conditions: Insomnia Due to Anxiety and Fear
• Interventions: Other: Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure; Other: Plain ear adhesive tape

• Registration Number: NCT05152095
• Lead Sponsor: International Medical University

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.

Study Timeline

• Study Start: 2021-11-13
• Status Verified: 2021-12
• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-05
• Study First Posted: 2021-12-09
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-30
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure	Self-administered Vaccaria seed tapes on auricular acupoints with pressure applied
Sham	Plain ear adhesive tape	Self-administered plain tapes (without Vaccaria seed) on auricular acupoints without applying pressure.

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Scale (HAM-A)	11th day	Total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Insomnia Severity Index (ISI)	11th 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)

Trial Locations

Locations (1)

International Medical University (IMU); 🇲🇾 Kuala Lumpur, Malaysia