Postoperative PainEASENCT07509294
Effect Of Electroacupuncture With Local Anesthesia On Pain And Stress During Impacted Lower Third Molar Surgery
A study testing Electroacupuncture in people with Postoperative Pain and Stress, Psychological, run by University of Zagreb at 1 site in Croatia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 35 years
- Conditions the study is for
- Postoperative Pain, Stress, Psychological, Impacted Lower Third Molar
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 20 Apr 2026to 18 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 25-35 years
- ASA physical status I-II
- Indication for ambulatory surgical extraction of an impacted lower third molar
- Ability to understand the study procedures and provide written informed consent
- Willingness to comply with study procedures, including saliva sampling protocol
- Ability to abstain from food, beverages, and oral hygiene procedures for at least 1 hour prior to saliva sampling
Who cannot join
- Pregnancy
- Epilepsy
- Presence of a pacemaker or other active electronic implant
- Coagulation disorders
- Active infection at the site of acupuncture
- Systemic inflammatory diseases
Show all 13Show fewer
- Oral inflammatory conditions (e.g., gingivitis or periodontitis)
- Hyposalivation
- Chronic opioid use
- Psychiatric conditions that may affect pain or stress assessment
- Use of nonsteroidal anti-inflammatory drugs, corticosteroids, or antibiotics within 7 days prior to the procedure
- Menstruation at the time of saliva sampling
- Inability or unwillingness to comply with study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Monika Ilić, MD contact
Croatia1 site
University Hospital Dubrava
Zagreb, 10000
Ivan Salaric, 003851 2902 444, salaric@sfzg.unizg.hr
About this study
Official title: Effect Of Electroacupuncture As An Adjunct To Local Anesthesia On Perioperative Pain And Stress During Ambulatory Surgical Extraction Of Impacted Lower Third Molars
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.
Read the detailed description
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.
- Being tested
- Electroacupuncture, Sham Acupuncture
- Keywords
- Electroacupuncture, Dental Anxiety, Third Molar Surgery, Cortisol, Alpha-Amylase, Substance P
- Medical subject headings
- Pain, Postoperative, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
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.
Sham AcupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Electroacupuncture |
| 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. Receives: Procedure: Sham Acupuncture |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 30 minutes after surgical extraction
Secondary outcomes (7)
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.
Measured: Baseline and 30 minutes after surgical extraction
Salivary Cortisol Levels
Salivary cortisol concentrations measured as a biomarker of stress response using enzyme-linked immunosorbent assay (ELISA).
Measured: 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).
Measured: Baseline and 30 minutes after surgical extraction
Salivary Substance P Levels
Salivary substance P concentrations measured using ELISA as a biomarker of nociceptive response.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and immediately after surgical extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion5 Oct 2026 (estimated)
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Salaric, University of Zagreb
- Investigators
- Jasminka Peršec, Associate Professor, PhD, Study chair, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509294
- Sponsor's protocol ID
- 003-01/26-05/02
- Acronym
- EASE
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Electroacupuncture As An Adjunct To Local Anesthesia On Perioperative Pain And Stress During Ambulatory Surgical Extraction Of Impacted Lower Third Molars
- ClinicalTrials.gov ID
- NCT07509294
- Acronym / sponsor ID
- EASE / 003-01/26-05/02
- Keywords
- Electroacupuncture, Dental Anxiety, Third Molar Surgery, Cortisol, Alpha-Amylase, Substance P
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 5 Oct 2026 (estimated)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture Group | Experimental | Procedure: ElectroacupunctureParticipants 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. |
| Sham Acupuncture Group | Sham comparator | Procedure: Sham AcupunctureParticipants 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. |
| 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. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 25-35 years
- ASA physical status I-II
- Indication for ambulatory surgical extraction of an impacted lower third molar
- Ability to understand the study procedures and provide written informed consent
- Willingness to comply with study procedures, including saliva sampling protocol
Key exclusion criteria (13 listed)
- Pregnancy
- Epilepsy
- Presence of a pacemaker or other active electronic implant
- Coagulation disorders
- Active infection at the site of acupuncture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureElectroacupuncture 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. | Procedure or surgery | Electroacupuncture Group |
| Sham AcupunctureSham 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. | Procedure or surgery | Sham Acupuncture Group |
Primary outcome
Perioperative Pain Intensity
Time frame: Baseline and 30 minutes after surgical extraction
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.
7 secondary outcomes
Perceived Stress
Time frame: Baseline and 30 minutes after surgical extraction
Salivary Cortisol Levels
Time frame: Baseline and 30 minutes after surgical extraction
Salivary Alpha-Amylase Levels
Time frame: Baseline and 30 minutes after surgical extraction
Salivary Substance P Levels
Time frame: Baseline and 30 minutes after surgical extraction
Systolic Blood Pressure
Time frame: Baseline and immediately after surgical extraction
Diastolic Blood Pressure
Time frame: Baseline and immediately after surgical extraction
Heart Rate
Time frame: Baseline and immediately after surgical extraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monika Ilić, MD contact
Jasminka Peršec, Associate Professor, PhD study chair
University Hospital Dubrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Postoperative Pain and Stress, Psychological, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Salaric, Associate Professor, PhD (003851290 2444, salaric@sfzg.unizg.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Pain Intensity (time frame: Baseline and 30 minutes after surgical extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.