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

NCT ID: NCT05152095

Last Updated: 2021-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-13

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Insomnia Due to Anxiety and Fear

Keywords

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auricular acupressure insomnia anxiety randomized sham controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Sham

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

Group Type SHAM_COMPARATOR

Plain ear adhesive tape

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Plain ear adhesive tape

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IMU University, Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Tang Sin Wei

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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International Medical University (IMU)

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Ms Tang

Role: CONTACT

Phone: 03-27317202

Email: [email protected]

Facility Contacts

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Ms Tang

Role: primary

Other Identifiers

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BCM I-2021 (04)

Identifier Type: -

Identifier Source: org_study_id