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NCT07888803

Effects of Manual Acupuncture on Malondialdehyde Levels and State Anxiety Inventory Scores in Active Smokers: A Randomized Controlled Clinical Trial

Sponsor: Universitas Indonesia

View on ClinicalTrials.gov

Summary

This study aims to evaluate the effects of a single session of manual acupuncture on oxidative stress and state anxiety in active smokers. Oxidative stress will be assessed using plasma malondialdehyde (MDA), while state anxiety will be evaluated using the State Anxiety Inventory (SAI). Participants will be randomly assigned to receive either manual acupuncture or sham acupuncture. MDA concentration and SAI scores will be assessed at baseline and 90 minutes after completion of the intervention. The study will also explore the correlation between changes in plasma MDA concentration and changes in SAI scores to assess the relationship between oxidative stress and state anxiety following the intervention.

Key Details

Gender

All

Age Range

21 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10

Completion Date

2026-12

Last Updated

2026-10-22

Healthy Volunteers

Conditions

Oxidative Stress

Interventions

DEVICE

The manual acupuncture therapy

In the intervention group, a Park Sham Needle Device was used with sterile 0.25 × 25 mm acupuncture needles. The needles were inserted perpendicularly to a depth of 20 mm at bilateral ST36, SP6, and HT7, and to a depth of 10 mm at GV20. The needles were retained for 30 minutes. Manual stimulation was performed using a twirling-rotating technique, consisting of alternating clockwise and counterclockwise needle rotation with a rotational amplitude of 180 degrees at a frequency of once per second for 10 seconds, at minute 0 and minute 15. After needle removal, gentle pressure was applied to the insertion sites for 10 seconds to ensure that no bleeding occurred.

DEVICE

The sham manual acupuncture therapy

In the control group, the same Park Sham Needle Device was used; however, the needle was blunt and did not penetrate the skin surface. The needle was placed at the same acupoints and retained for 30 minutes without manipulation.

Inclusion Criteria: * Male or female participants aged 21-40 years. * Active cigarette smokers, defined as smoking ≥20 cigarettes per day for \>5 years, and meeting the Centers for Disease Control and Prevention (CDC) definition of a current smoker: an adult who has smoked at least 100 cigarettes in their lifetime and currently smokes cigarettes. * No previous history of manual acupuncture treatment. * Body mass index (BMI) of 18.5-29.9 kg/m². * Willing and able to comply with all study procedures and to provide written informed consent. * Able to communicate adequately and independently complete the study questionnaires. Exclusion Criteria: * Use of tobacco or nicotine products other than conventional cigarettes, including e-cigarettes, vaping products, hand-rolled cigarettes, nicotine patches, or nicotine gum. * Current fever or body temperature \>37.5°C at screening. * Previous diagnosis of a chronic disease, including autoimmune disease, cancer, liver disease, kidney disease, pulmonary disease, or cardiovascular disease. * History of metabolic syndrome, defined as the presence of ≥3 components, including central obesity, dyslipidemia, hypertension, and diabetes mellitus. * Skin lesions at or near the acupuncture needle insertion sites, including tumors, wounds, keloids, or infections. * History of a hematologic disorder, including platelet count \<20,000/mm³ and/or absolute neutrophil count (ANC) \<500/mm³, or current use of systemic anticoagulants such as warfarin or heparin, direct oral anticoagulants, or antiplatelet agents such as aspirin or clopidogrel. * History of allergy or hypersensitivity to metals, particularly materials used in acupuncture needles. * Currently undergoing smoking-cessation treatment, including pharmacologic, behavioral, or other smoking-cessation therapies. * Regular use of high-dose antioxidant supplements or other routine supplements within the previous 4 weeks. * Use of anti-inflammatory medications within the previous 2 weeks.

Locations (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia