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

Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety: A Randomized Sham-controlled Trial

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ms Tang; Phone Number: 03-27317202; Email: freyatang@imu.edu.my

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia
    • Recruiting
    • International Medical University (IMU)
    • Contact: Ms Tang; Phone Number: 03-27317202

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Self-administered Vaccaria seed tapes on auricular acupoints with pressure applied	Other: Vaccaria 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.
SHAM_COMPARATOR: Sham; Self-administered plain tapes (without Vaccaria seed) on auricular acupoints without applying pressure.	Other: Plain ear adhesive tape; Apply on Shenmen and Occiput without applying pressure for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: International Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 13, 2021
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 31, 2022

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 5, 2021
• First Posted (ACTUAL): December 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: insomnia; anxiety; auricular acupressure; randomized sham controlled trial
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Anxiety Disorders
• Other Study ID Numbers: BCM I-2021 (04)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No