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NCT06149598 | COMPLETED | Cervical Cancer

Coughing at Time of Cervical Biopsy
Sponsor:

Zydolab - Institute of Cytology and Immune Cytochemistry

Information provided by (Responsible Party):

Dr. med. Hilal ziot

Brief Summary:

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

Condition or disease

Cervical Cancer

Cervical Dysplasia

Colposcopy

Pain Sensation

Cervical Biopsy

Intervention/treatment

Coughing at the time of biopsy

Phase

NA

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Pain Reduction by Forced Coughing During Colposcopy Guided Cervical Biopsies: a Randomized Controlled Pilot Study
Actual Study Start Date : 2024-01-02
Estimated Primary Completion Date : 2024-04-30
Estimated Study Completion Date : 2024-05-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Coughing at Time of Cervical Biopsy

Location Details

NCT06149598

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Locations

Not yet recruiting

Germany, NRW

Zydolab - Institute of Cytology and Immune Cytochemistry

Dortmund, NRW, Germany, 44137