Coughing at Time of Cervical Biopsy

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

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

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Colposcopy; Cervical Dysplasia; Pain Sensation; Cervical Biopsy
• Intervention / Treatment: Behavioral: Coughing at the time of 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Dortmund, NRW, Germany, 44137
      • Zydolab - Institute of Cytology and Immune Cytochemistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coughing at the time of first 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.	Behavioral: Coughing at the time of biopsy; Patients are asked to cough or not to cough during cervical biopsy.
Active Comparator: Coughing at the time of second 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.	Behavioral: Coughing at the time of biopsy; Patients are asked to cough or not to cough during cervical biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in pain between first and second biopsy	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.	Immediately after the examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception before 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.	Immediately before the start of the examination
Pain perception when inserting 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.	Immediately after the insertion of the specula
Pain perception when using 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.	Immediately after the application of acetic acid
Pain perception at first biopsy	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.	Immediately after the first biopsy was performed
Pain perception at second biopsy	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.	Immediately after the second biopsy was performed
Pain perception just after examination	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.	Immediately after the removal of the specula

Collaborators and Investigators

• Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: pain; cervical dysplasia; cervical cancer; distraction; coughing; cervical biopsy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Diseases; Uterine Diseases; Genital Diseases, Female; Respiration Disorders; Genital Neoplasms, Female; Precancerous Conditions; Uterine Cervical Diseases; Signs and Symptoms, Respiratory; Uterine Neoplasms; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Cough
• Other Study ID Numbers: COLPO-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No