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

Primary Purpose

Insomnia Due to Anxiety and Fear

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure
Plain ear adhesive tape
Sponsored by
International Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Due to Anxiety and Fear focused on measuring auricular acupressure, insomnia, anxiety, randomized sham controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • International Medical University (IMU)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention

Sham

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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)
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 1, 2021
Last Updated
December 10, 2021
Sponsor
International Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05152095
Brief Title
Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety
Official Title
Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety: A Randomized Sham-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 13, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Due to Anxiety and Fear
Keywords
auricular acupressure, insomnia, anxiety, randomized sham controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Self-administered Vaccaria seed tapes on auricular acupoints with pressure applied
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Self-administered plain tapes (without Vaccaria seed) on auricular acupoints without applying pressure.
Intervention Type
Other
Intervention Name(s)
Vaccaria seed (Wang Bu Liu Xing) pre-attached to adhesive tape used for auricular acupressure
Intervention Description
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 Type
Other
Intervention Name(s)
Plain ear adhesive tape
Intervention Description
Apply on Shenmen and Occiput without applying pressure for 5 days.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
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
Title
Insomnia Severity Index (ISI)
Description
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
Title
Hamilton Anxiety Rating Scale (HAM-A)
Description
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
Title
Hamilton Anxiety Rating Scale (HAM-A)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ms Tang
Phone
03-27317202
Email
freyatang@imu.edu.my
Facility Information:
Facility Name
International Medical University (IMU)
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ms Tang
Phone
03-27317202

12. IPD Sharing Statement

Plan to Share IPD
No

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

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