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Effect of local ice before anesthesia for vulva biopsies on the comfort of outpatients

Effect of local cooling prior to anesthesia for vulva biopsies on the comfort of outpatients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-103bvzkh
Enrollment
Unknown
Registered
2024-12-03
Start date
2024-09-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

sharp pain

Interventions

This is a randomized, randomized clinical trial. The population to be studied will be women over 18 years of age, undergoing vulvar biopsy to evaluate vulvar lesions. Patients who agree to participate
E02.258

Sponsors

Hospital da Mulher Prof. Dr. J. A. Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Universidade Estadual de Campinas - UNICAMP
Lead Sponsor
Universidade Estadual de Campinas - UNICAMP
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Women over 18; women in the process of diagnosis and treatment of Lower Genital Tract Pathologies; women with preserved motor skills (nerve and muscular functions) of the lower limbs; women with preserved local sensitivity

Exclusion criteria

Exclusion criteria: Previous motor deficiency in lower limbs; non-communicating patient; patients with cold urticaria

Design outcomes

Primary

MeasureTime frame
Pain, defined as a painful sensation in the region of the lower genital tract to be biopsied. Measured at the time of anesthesia using the visual analogue scale – VAS. Classified as “Present” or “/Absent”, if present, quantification from 1 to 10 and mild, moderate and severe; and measured after procedure anesthesia using the McGill Short Summer Pain Questionnaire score.

Secondary

MeasureTime frame
Pelvic floor muscle functionality, determined by the PERFECT classification of pelvic floor muscle functionality, through unidigital palpation, assessed before the vulval biopsy procedure.

Countries

Brazil

Contacts

Public ContactJuliana Fernandes

Universidade Estadual de Campinas - UNICAMP

olvr.fernandes@gmail.com+55 (19) 98747-5459

Outcome results

None listed

Source: REBEC (via WHO ICTRP)