Coughing at Time of Cervical Biopsy

Zydolab - Institute of Cytology and Immune Cytochemistry

Status: Completed

Conditions: Pain Sensation; Colposcopy; Cervical Dysplasia; Cervical Biopsy; Cervical Cancer

Treatments: Behavioral: Coughing at the time of biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06149598

COLPO-6

Details and patient eligibility

About

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

Full 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).

Enrollment: 30 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Coughing at the time of first biopsy

Experimental group

Description:

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.

Treatment:

Behavioral: Coughing at the time of biopsy

Coughing at the time of second biopsy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Coughing at the time of biopsy