NCT06149598

Coughing at Time of Cervical Biopsy

Pain Reduction by Forced Coughing During Colposcopy Guided Cervical Biopsies: a Randomized Controlled Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Cervical Cancer
• Cervical Dysplasia
• Colposcopy
• Pain Sensation
• Cervical Biopsy

Interventions

Type	Name	Description
BEHAVIORAL	Coughing at the time of biopsy	Patients are asked to cough or not to cough during cervical biopsy.

Timeline

• Start date: 2024-01-02
• Primary completion: 2024-04-30
• Completion: 2024-05-30
• First posted: 2023-11-29
• Last updated: 2025-03-04

Locations

1 site across 1 country: Germany