Coughing at Time of Cervical Biopsy

Trial Title: Coughing at Time of Cervical Biopsy

NCT ID: NCT06149598

Condition: Cervical Cancer
Cervical Dysplasia
Colposcopy
Pain Sensation
Cervical Biopsy

Conditions: Official terms:
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Cough

Conditions: Keywords:
cervical cancer
cervical dysplasia
cervical biopsy
pain
coughing
distraction

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Coughing at the time of biopsy
Description: Patients are asked to cough or not to cough during cervical biopsy.
Arm group label: Coughing at the time of first biopsy
Arm group label: Coughing at the time of second biopsy

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

Criteria for eligibility:
Criteria:
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

Gender: Female

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Zydolab - Institute of Cytology and Immune Cytochemistry

Address:
City: Dortmund
Zip: 44137
Country: Germany

Status: Recruiting

Contact:
Last name: Ziad Hilal, M.D.

Phone: +0049 231 579349
Email: z.hilal@zydolab.de

Start date: January 2, 2024

Completion date: May 1, 2025

Lead sponsor:
Agency: Zydolab - Institute of Cytology and Immune Cytochemistry
Agency class: Other

Source: Zydolab - Institute of Cytology and Immune Cytochemistry

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06149598