Coughing at Time of Cervical Biopsy

Not Applicable

Completed

• Conditions: Cervical Cancer; Cervical Biopsy; Cervical Dysplasia; Colposcopy; Pain Sensation
• Interventions: Behavioral: Coughing at the time of biopsy

• Registration Number: NCT06149598
• Lead Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry

Brief 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).

Study Timeline

• Study First Submitted: 2023-11-19
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-11-29
• Study Start: 2024-01-02
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Completed 18 years of age
• written informed consent
• first colposcopy
• Clinically indicated colposcopy in case of an abnormal PAP smear or screening result and/or clinical abnormalities on the cervix uteri
• Necessity to take exactly two biopsies

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 or lead to permanent pain due to the disease itself
• psychosomatic illnesses
• Chronic use of pain medications or psychotropic medications or other medications that may have an influence on the sensation of pain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Coughing at the time of first biopsy	Coughing at the time of biopsy	Patients are asked to cough during the first biopsy. They should not cough during the second biopsy, and no additional interventions will be performed during the second biopsy.
Coughing at the time of second biopsy	Coughing at the time of biopsy	Patients are asked to cough during the second biopsy. They should not cough during the first biopsy, and no additional interventions will be performed during the first biopsy.

Primary Outcome Measures

Name	Time	Method
Difference in pain between first and second biopsy	Immediately after the examination	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). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.

Secondary Outcome Measures

Name	Time	Method
Pain perception when inserting the specula	Immediately after the insertion of the specula	the patients' perception of pain at the moment of the insertion of the specula, measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
Pain perception when using acetic acid	Immediately after the application of acetic acid	the patients' perception of pain at the moment of the application of acetic acid, measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
Pain perception at second biopsy	Immediately after the second biopsy was performed	the patients' perception of pain during the second biopsy, measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
Pain perception before examination	Immediately before the start of the examination	the patients' perception of pain before examination, measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
Pain perception just after examination	Immediately after the removal of the specula	the patients' perception of pain just after finishing the examination, measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
Pain perception at first biopsy	Immediately after the first biopsy was performed	the patients' perception of pain during the first biopsy, measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.

Trial Locations

Locations (1)

Zydolab - Institute of Cytology and Immune Cytochemistry; 🇩🇪 Dortmund, NRW, Germany