Pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Women of reproductive age; clinical indication for intrauterine device insertion; attendance for elective intrauterine device insertion; ability to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Confirmed or suspected pregnancy; clinical contraindication to intrauterine device use; prior use of analgesics or anxiolytics immediately before the procedure; known allergy to components of the floral therapy or placebo; inability to understand study instructions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: It is expected to assess pain intensity during intrauterine device insertion, verified by means of the Visual Analog Scale for pain, based on the comparison of scores obtained immediately before and after the procedure, considering a clinically relevant difference between the intervention and control groups. ;Expected outcome 2: It is expected to assess the level of anxiety of the participants at the time of intrauterine device insertion, verified by means of a standardized anxiety assessment instrument, based on the comparison of pre- and post-intervention scores between the groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 3: It is expected to assess the need for interruption or the occurrence of difficulties during the intrauterine device insertion procedure, verified through standardized clinical records of the procedure, considering the occurrence of adverse events or intercurrent events. | — |
Countries
Brazil
Contacts
Universidade Federal da Paraíba (UFPB)