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This randomized controlled trial investigates the effect of electroacupuncture as an adjunct to local anesthesia on perioperative pain and stress during ambulatory surgical extraction of impacted lower third molars. Participants will be randomized into three groups: electroacupuncture, sham acupuncture, and control. Pain intensity and perceived stress will be assessed using validated scales, while biological stress and nociceptive markers (salivary cortisol, alpha-amylase, and substance P), as well as hemodynamic parameters (blood pressure and heart rate), will be measured. The study aims to provide an integrated evaluation of the effects of electroacupuncture on subjective, biological, and physiological indicators of perioperative response in oral surgery.
Perioperative pain and stress during surgical extraction of impacted lower third molars remain clinically relevant despite the use of local anesthesia. Psychological factors such as dental anxiety and physiological stress responses contribute to variability in pain perception and perioperative outcomes. Electroacupuncture has been proposed as a non-pharmacological adjunct that may modulate both nociceptive and stress-related pathways through neurohumoral mechanisms, including endogenous opioid release and autonomic regulation.
This prospective randomized controlled trial is designed to evaluate the effect of electroacupuncture as an adjunct to local anesthesia on perioperative response in patients undergoing ambulatory surgical extraction of impacted lower third molars. The study incorporates a three-arm parallel design, including electroacupuncture, sham acupuncture, and standard care without acupuncture, allowing differentiation between specific and non-specific effects of the intervention.
An integrated assessment approach will be used to capture multiple dimensions of the perioperative response, including subjective, biological, and physiological components. This design enables a comprehensive evaluation of the interaction between stress, autonomic activation, and nociceptive processing in a standardized oral surgery model. The findings are expected to contribute to the understanding of the clinical value of electroacupuncture as an adjunctive modality in perioperative care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture Group | Experimental | Participants receive electroacupuncture for 15 minutes prior to administration of local anesthesia, according to a standardized protocol involving selected local and distal acupuncture points. Electrical stimulation is applied using a digital electroacupuncture device at an individually adjusted intensity sufficient to produce a clear sensation without pain or discomfort. Following the intervention, participants undergo standard surgical extraction of the impacted lower third molar under local anesthesia. |
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| Sham Acupuncture Group | Sham Comparator | Participants receive a sham acupuncture procedure for 15 minutes prior to administration of local anesthesia. This involves superficial needle insertion at non-acupuncture points without electrical stimulation or needle manipulation, mimicking the procedural aspects of electroacupuncture without therapeutic effect. The duration and conditions are identical to the electroacupuncture group. After the procedure, participants undergo standard surgical extraction under local anesthesia. |
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| Control Group | No Intervention | Participants receive standard care consisting of local anesthesia and surgical extraction of the impacted lower third molar without any acupuncture intervention. All other aspects of perioperative management are consistent with routine clinical practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture | Procedure | Electroacupuncture is applied for 15 minutes prior to local anesthesia using a standardized protocol with selected acupuncture points. Electrical stimulation is delivered via a digital electroacupuncture device at an individually adjusted intensity to produce a clear but non-painful sensation. |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Pain Intensity | Perioperative pain intensity assessed using a Numeric Rating Scale (NRS 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores represent a worse outcome. | Baseline and 30 minutes after surgical extraction |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress | Perceived stress assessed using a Numeric Rating Scale (NRS 0-10), where 0 indicates no stress and 10 indicates the highest perceived stress, and the 10-item Perceived Stress Scale (PSS-10); higher scores on both scales indicate greater perceived stress and a worse outcome. | Baseline and 30 minutes after surgical extraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivan Salaric, Associate Professor, PhD | Contact | 003851290 2444 | salaric@sfzg.unizg.hr | |
| Monika Ilić, MD | Contact | monika.seric.ilic@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jasminka Peršec, Associate Professor, PhD | University Hospital Dubrava | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Dubrava | Zagreb | 10000 | Croatia |
Individual participant data will not be shared due to privacy considerations and the absence of a predefined data-sharing plan within this investigator-initiated study. Data will be reported in aggregate form in scientific publications.
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Participants will be randomized in a 1:1:1 ratio into three parallel groups: electroacupuncture, sham acupuncture, and control. Each participant will receive only one assigned intervention, and outcomes will be compared between groups.
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Participants will be blinded to group assignment through the use of a sham acupuncture procedure that mimics the active intervention without therapeutic effect. Outcome assessment will be performed using standardized measures, and laboratory analyses will be conducted on coded samples without knowledge of group allocation.
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| Sham Acupuncture | Procedure | Sham acupuncture consists of superficial needle insertion at non-acupuncture points without electrical stimulation or needle manipulation. The procedure mimics the active intervention in duration and setting but is designed to have no therapeutic effect. |
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| Salivary Cortisol Levels | Salivary cortisol concentrations measured as a biomarker of stress response using enzyme-linked immunosorbent assay (ELISA). | Baseline and 30 minutes after surgical extraction |
| Salivary Alpha-Amylase Levels | Salivary alpha-amylase concentrations measured as an indicator of sympathetic activity using enzyme-linked immunosorbent assay (ELISA). | Baseline and 30 minutes after surgical extraction |
| Salivary Substance P Levels | Salivary substance P concentrations measured using ELISA as a biomarker of nociceptive response. | Baseline and 30 minutes after surgical extraction |
| Systolic Blood Pressure | Systolic arterial blood pressure measured noninvasively using a validated automated digital monitor as an indicator of autonomic response, reported in millimeters of mercury (mmHg). | Baseline and immediately after surgical extraction |
| Diastolic Blood Pressure | Diastolic arterial blood pressure measured noninvasively using a validated automated digital monitor as an indicator of autonomic response, reported in millimeters of mercury (mmHg). | Baseline and immediately after surgical extraction |
| Heart Rate | Heart rate measured using a validated automated digital monitor as an indicator of autonomic response, reported in beats per minute (bpm). | Baseline and immediately after surgical extraction |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
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