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

NCT05152095 | Unknown

• 1 other identifier: BCM I-2021 (04)
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Due to Anxiety and Fear

Keywords

auricular acupressure; insomnia; anxiety; randomized sham controlled trial

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Sham

SHAM COMPARATOR

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

Other: Plain ear adhesive tape

Interventions

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

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.

Intervention

Plain ear adhesive tape OTHER

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

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IMU University, Malaysia: lead

Study Sites (1)

International Medical University (IMU)

Kuala Lumpur, Malaysia

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Ms Tang

CONTACT

03-27317202; freyatang@imu.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 9, 2021
• Study Start: November 13, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 31, 2022
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)