Skip to main content
OpenTrials
Completed

NCT Number: NCT06149598

Coughing at Time of Cervical Biopsy

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coughing at the time of biopsy

Behavioral

Patients are asked to cough or not to cough during cervical biopsy.

Primary outcomes

  1. Difference in pain between first and second biopsy

    Time frame: 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 outcomes

  1. Pain perception before examination

    Time frame: 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.

  2. Pain perception when inserting the specula

    Time frame: 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.

  3. Pain perception when using acetic acid

    Time frame: 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.

  4. Pain perception at first biopsy

    Time frame: 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.

  5. Pain perception at second biopsy

    Time frame: 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.

  6. Pain perception just after examination

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2023
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.