Coughing at Time of Cervical Biopsy

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149598
• Other study ID #: COLPO-6
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: January 2024
• Source: Zydolab - Institute of Cytology and Immune Cytochemistry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Biopsy
• Cervical Cancer
• Cervical Dysplasia
• Colposcopy
• Cough
• Pain Sensation
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Coughing at the time of biopsy
Patients are asked to cough or not to cough during cervical biopsy.

Locations

Country	Name	City	State
Germany	Zydolab - Institute of Cytology and Immune Cytochemistry	Dortmund	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Zydolab - Institute of Cytology and Immune Cytochemistry

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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