Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT06202794
Eligibility Criteria:
Inclusion Criteria:
* female sex, age between 18 to 55 years in the immediate postoperative period of mastopexy with implants;
* score \> 3 for pain intensity on the numeric pain scale (NRS) reported during post-surgery screening;
* no previous experience with the use of TENS or electrical currents for analgesia;
* not having undergone any other type of surgery in the chest region, taking medications to control pain or anxiety, or having a history of pain in the breast region.
* None of the individuals should use bronchodilator therapy or medications that directly act on the respiratory system.
Exclusion Criteria:
* frequent use of bronchodilators, analgesics, muscle relaxants, or psychotropics or allergy to any medication that interferes with surgery (morphine, dipyrone, propofol, lidocaine);
* pregnancy, previous abdominal surgeries, or pre-surgical breast pain;
* any type of inflammatory disease, systemic lupus erythematosus, dermatomyositis or dermatitis in the treatment area, cancer, tumors of any type diagnosed in the previous five years;
* history of epilepsy, metal devices implanted in the body;
* any musculoskeletal injury in the cervical spine, neck or shoulder in the previous three months (fractures, sprains, tendinopathies, dislocations or muscle ruptures) or having a cardiac device, such as an internal automatic defibrillator or pacemaker.
* All patients undergoing combined surgeries or who undergo another surgical procedure in addition to mastopexy with implants or who have knowledge or previous use of TENS or electrical currents for the treatment of pain will be excluded.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06202794
Study Brief:
Protocol Section:
NCT06202794