Transcutaneous electric nerve stimulation
Conditions
Interventions
This is a randomized, controlled, parallel clinical trial with three intervention groups allocated in a 1:1:1 ratio, according to a computer-generated randomization list in blocks of 10 participants.
Sponsors
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Women aged 18–45 years; nulliparous or multiparous; with indication for intrauterine device insertion, regardless of type; attending the Family Planning Clinic of UNICAMP; able to understand the study and provide written informed consent
Exclusion criteria
Exclusion criteria: Diagnosis of chronic pelvic pain; chronic or pre-procedure use of opioids or psychoactive drugs; skin lesions at the electrode application site; use of a pacemaker or implantable cardiac defibrillator; neurological impairment; inability to understand the study or refusal to provide informed consent; previous experience with Transcutaneous Electrical Nerve Stimulation; contraindications to ketorolac tromethamine, including hypersensitivity to Nonsteroidal Anti-Inflammatory Drugs; history of asthma or allergic reactions to Nonsteroidal Anti-Inflammatory Drugs; active peptic ulcer disease, gastrointestinal bleeding or coagulation disorders, severe renal or hepatic impairment, or use of anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the application of transcutaneous electrical nerve stimulation during intrauterine device insertion will be superior to ketorolac tromethamine and usual care in reducing pain intensity as measured by the visual analog scale;It is expected that application of transcutaneous electrical nerve stimulation will be more effective in reducing immediate discomfort after intrauterine device insertion compared with medication and usual care;It is expected that women undergoing transcutaneous electrical nerve stimulation will report greater satisfaction with the procedure than those receiving medication or usual care;It is expected that the rate of unsuccessful intrauterine device insertion will be similar across the three study groups;It is expected that the application of transcutaneous electrical nerve stimulation will not increase the total duration of intrauterine device insertion compared with medication alone or usual care;It is expected that anxiety levels will be similar across all groups transcutaneous electrical nerve stimulation, medication, and usual care | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
BR
Contacts
Public ContactAna Lisboa Lima Fontes
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Outcome results
None listed