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The goal of this clinical trial is to evaluate the feasibility and preliminary effectiveness of auricular acupressure (ear seeds) combined with nicotine replacement therapy (NRT) in psychiatric inpatients (both male and female, aged 18-65) who are forced to abstain from smoking due to the smoke-free environment of the inpatient ward. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular Acupressure Group | Experimental | Participants in this group will receive standard Nicotine Replacement Therapy (NRT) combined with active auricular acupressure. Vaccaria seeds will be applied to specific acupuncture points (e.g., Shenmen, Lung, Subcortex). |
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| Sham Auricular Acupressure Group | Sham Comparator | Participants in this group will receive standard Nicotine Replacement Therapy (NRT) combined with sham auricular acupressure. Sham material with no active stimulation will be applied to specific acupuncture points. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular acupressure | Device | Participants will receive standard Nicotine Replacement Therapy (NRT) as prescribed by their attending psychiatrist (e.g., nicotine patches or gum). In addition, active auricular acupressure will be applied using Vaccaria seeds on five specific ear acupuncture points: Shenmen (TF4), Lung (CO14), Subcortex (AT4), Endocrine(CO18) and Sympathetic (AH6a). The intervention will last for 28 days. Participants will be instructed to press each bead for 1-2 minutes, 3 times daily (morning, noon, and evening) or whenever they feel a strong craving for a cigarette. The ear patches will be replaced every week to ensure hygiene and adhesive effectiveness. |
| Measure | Description | Time Frame |
|---|---|---|
| Craving scale | A 100-mm Visual Analogue Scale (VAS) used to measure the participant's subjective "urge to smoke" at the moment of evaluation. The scale ranges from 1 (no craving at all) to 100 (extreme craving). Participants mark a number on the line that represents their current craving level. | Baseline, Day 14, Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Minnesota Nicotine Withdrawal Scale (MNWS) Total Score | The MNWS is a self-reported scale used to assess the severity of nicotine withdrawal symptoms over the past 24 hours. It consists of 9 items (e.g., urge to smoke, irritability, anxiety, difficulty concentrating). Each item is rated on a 5-point Likert scale from 0 (none) to 4 (severe). The total score ranges from 0 to 36, with higher scores indicating more severe withdrawal symptoms. A reduction of 3 points or more is pre-specified as a clinically significant improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiao Chiao Liao | Contact | +886 963674763 | l23ful6@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tsaotun Psychiatric Center, Ministry of Health and Welfare | Recruiting | Nantou City | 542 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26892910 | Background | Soyster P, Anzai NE, Fromont SC, Prochaska JJ. Correlates of nicotine withdrawal severity in smokers during a smoke-free psychiatric hospitalization. Prev Med. 2016 Nov;92:176-182. doi: 10.1016/j.ypmed.2016.01.026. Epub 2016 Feb 15. | |
| 24138333 | Background | Zhang CS, Yang AW, Zhang AL, May BH, Xue CC. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. doi: 10.1089/acm.2013.0238. Epub 2013 Oct 19. |
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To protect the privacy of the psychiatric inpatients and comply with the institutional ethical guidelines, there is no plan to share individual participant data (IPD) with the public. However, the study protocol and the statistical analysis plan may be available upon reasonable request to the corresponding author after the study's completion and publication.
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| Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge) | Drug | All participants in both the experimental and control groups will receive standard-of-care Nicotine Replacement Therapy (NRT) as prescribed by their attending psychiatrist. The dosage (e.g., 21mg, 14mg, or 7mg nicotine patches; 2mg or 4mg nicotine gum) will be determined based on each patient's baseline nicotine dependence level (Fagerström Test for Nicotine Dependence) and clinical psychiatric stability. NRT administration will follow the hospital's clinical protocols for inpatient smoking cessation to manage withdrawal symptoms safely within the psychiatric ward. |
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| Sham Auricular Acupressure | Device | Participants in the control group will receive sham auricular acupressure. To ensure blinding, placebo patches without seeds (containing inactive, non-stimulating material) that are identical in appearance to the active patches will be used. These sham patches will be applied to the same acupuncture points (Shenmen, Lung, Endocrine, Sympathetic, and Subcortex) as the experimental group. Participants will receive the same instructions to apply manual pressure 3 to 5 times daily, maintaining consistency in behavioral intervention and ensuring the integrity of the double-blind design. |
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| Baseline, Day 14, and Day 28 |
| Hamilton Anxiety Rating Scale (HAMA) Total Score | A clinician-rated scale used to evaluate the severity of anxiety symptoms. It consists of 14 items, each scored on a scale of 0 (not present) to 4 (very severe). The total score ranges from 0 to 56, where higher scores represent greater anxiety severity. | Baseline, Day 14, and Day 28 |
| Autonomic Nervous System Function as Measured by Heart Rate Variability | Heart Rate Variability (HRV) will be recorded using a standardized 5-minute resting protocol to evaluate the participants' autonomic nervous system (ANS) regulation. Various time-domain and frequency-domain indices will be calculated from the inter-beat interval (IBI) data. Higher variability generally reflects better adaptive capacity of the ANS in response to nicotine withdrawal stress. | Baseline, Day28 |
| 39931130 | Background | Mi Q, Zhao X, Zhang Z, Bao F. The effectiveness and safety of auricular acupoint-related therapy for nicotine dependence: A systematic review and meta-analysis. Tob Induc Dis. 2025 Feb 10;23. doi: 10.18332/tid/200550. eCollection 2025. |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| D000095488 | Nicotine Replacement Therapy |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
| D004358 | Drug Therapy |
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