Coughing at Time of Cervical Biopsy

Sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06149598

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Cervical Dysplasia Colposcopy Pain Sensation Cervical Biopsy	Behavioral: Coughing at the time of biopsy	N/A

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:

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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 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 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.
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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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