Coughing at Time of Cervical Biopsy

Zydolab - Institute of Cytology and Immune Cytochemistry30 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Cancer Cervical Dysplasia Colposcopy Pain Sensation Cervical Biopsy

Interventions

Coughing at the time of biopsyBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Zydolab - Institute of Cytology and Immune Cytochemistry

Dortmund, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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.

Time frame: Immediately after the examination

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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