N87
Conditions
Interventions
Group 1: Patients cough during the first biopsy, they do not cough during the second biopsy
Group 2: Patients cough during the second biopsy, they do not cough during the first biopsy
Sponsors
GYNDOMED - Frauenärztliches Versorgungszentrum
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - 18 years of age or older - Written consent to participate in the study - Clinically indicated clarification colposcopy with abnormal PAP smear for the detection of precancerous lesions of the cervix uteri and/or clinical abnormalities of the cervix uteri (e.g. leukoplakia) with biopsy - Need to take exactly two biopsies - First presentation for colposcopic examination
Exclusion criteria
Exclusion criteria: - Performing only one biopsy or more than two biopsies - Endocervical curettage (biopsy of the endocervix) - Vaginal bleeding at the time of the examination - Inadequate colposcopy (An inadequate colposcopy is an examination that is not representative and medically evaluable due to external or internal circumstances. This includes the following situations: local infections, scarring, anatomical variations. The assessment of adequate/inadequate colposcopy is a standardized part of the RIO classification form) - Cervix uteri that cannot be fully visualized - pregnancy - Patients with insufficient German language skills - known anxiety disorders or depressive disorders - Treatments already performed on the cervix uteri - Patients with a chronic or acute illness that affects the sensation of pain or leads to permanent pain due to the illness itself - psychosomatic illnesses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in patients' perception of pain during the first and second biopsy of the cervix, measured using an 11-item numerical analog scale (11-item NAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary target parameters are - the patients' perception of pain immediately before the examination (11-item NAS), - the patients' perception of pain during the insertion of the speculum at the start of the examination (11-item NAS), - the patients' perception of pain during the application of the acetic acid solution (11-item NAS), - the patients' perception of pain immediately after the examination (11-item NAS) | — |
Countries
Germany
Contacts
Public ContactZiad Hilal
GYNDOMED - Frauenärztliches Versorgungszentrum
Outcome results
None listed