Coughing at Time of Cervical Biopsy

NCT06149598 | Completed

• 1 other identifier: COLPO-6
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

cervical cancer; cervical dysplasia; cervical biopsy; pain; coughing; distraction

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after the examination

Secondary Outcomes (6)

• Pain perception before examination

  Immediately before the start of the examination

• Pain perception when inserting the specula

  Immediately after the insertion of the specula

• Pain perception when using acetic acid

  Immediately after the application of acetic acid

• Pain perception at first biopsy

  Immediately after the first biopsy was performed

• Pain perception at second biopsy

  Immediately after the second biopsy was performed

Study Arms (2)

Coughing at the time of first biopsy

EXPERIMENTAL

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

Coughing at the time of second biopsy

ACTIVE COMPARATOR

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

Interventions

Coughing at the time of biopsy BEHAVIORAL

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

Coughing at the time of first biopsy; Coughing at the time of second biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zydolab - Institute of Cytology and Immune Cytochemistry: lead

Study Sites (1)

Zydolab - Institute of Cytology and Immune Cytochemistry

Dortmund, North Rhine-Westphalia, 44137, Germany

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Pain; Cough

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 29, 2023
• Study Start: January 2, 2024
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)