Coughing at Time of Cervical Biopsy

Last updated: February 27, 2025
Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry
Overall Status: Completed

Phase

N/A

Condition

Vaginal Cancer

Dysfunctional Uterine Bleeding

Cervical Dysplasia

Treatment

Coughing at the time of biopsy

Clinical Study ID

NCT06149598
COLPO-6
  • Ages 18-80
  • Female

Study Summary

To investigate the effect of coughing as an intervention to reduce pain in colposcopy guided biopsy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completed 18 years of age

  • written informed consent

  • first colposcopy

  • Clinically indicated colposcopy in case of an abnormal PAP smear or screening resultand/or clinical abnormalities on the cervix uteri

  • Necessity to take exactly two biopsies

Exclusion

Exclusion Criteria:

  • Performing only one biopsy or more than two biopsies

  • Performing an endocervical curettage (biopsy on the endocervix)

  • Vaginal bleeding at the time of examination

  • inadequate colposcopy

  • Cervix uteri cannot be fully visualized

  • Pregnancy

  • Patients with insufficient German language skills

  • known anxiety disorders or depressive disorders

  • Treatments already carried out on the cervix uteri

  • Patients with a chronic or acute illness that influences the perception of pain orlead to permanent pain due to the disease itself

  • psychosomatic illnesses

  • Chronic use of pain medications or psychotropic medications or other medicationsthat may have an influence on the sensation of pain

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Coughing at the time of biopsy
Phase:
Study Start date:
January 02, 2024
Estimated Completion Date:
May 30, 2024

Study Description

Colposcopy is a frequently practiced examination and Colposcopy guided biopsy causes pain. A few trials Investigated whether medical interventions such as the application of lidocaine led to reduced pain perception with inconsistent results. Only one trial compared coughing versus no coughing at the moment of biopsy. Although the results of this study did not lead to a significant difference between the two study arms, coughing seems to positively affect pain perception.

Since the patients are, in the best case, their own controls when it comes to subjective parameters such as pain perception, we prefer a cross-over rather than a parallel group design.

Based on the descriptive variables for pain during biopsy with and without cough determined in the pilot study, a case estimate for a prospective randomized cross-over study will be carried out. Since two biopsies are usually taken from the cervix in daily practice, the now planned pilot study in a cross-over design envisages the following two study arms:

  1. Group I: Patients cough during the first biopsy, they do not cough during the second biopsy

  2. Group II: Patients cough during the second biopsy, they do not cough during the first biopsy

The primary Outcome measure is the difference in the patients' perception of pain during the first and second biopsy on the cervix (ectocervix), measured using an 11-part numerical analogue scale (11-item NAS).

Connect with a study center

  • Zydolab - Institute of Cytology and Immune Cytochemistry

    Dortmund, NRW 44137
    Germany

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.