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Use of floral therapy to reduce pain and anxiety during intrauterine device insertion

Use of Floral Therapy for Pain and Anxiety During Intrauterine Device Insertion: A Triple-Blind Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7wvmyhx
Enrollment
Unknown
Registered
2026-01-27
Start date
2024-07-02
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Interventions

This is a randomized, controlled, two-arm, triple-blind clinical trial. The sample consists of a minimum of one hundred and five women and may reach a maximum of three hundred participants, according

Sponsors

Universidade Federal da Paraíba (UFPB)
Lead Sponsor
Universidade Federal da Paraíba (UFPB)
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactJuan Silva

Universidade Federal da Paraíba (UFPB)

juan.pedro@academico.ufpb.com+55 (83) 3216-7791

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 7, 2026