Clinical trial NCT06149598: Coughing at Time of Cervical Biopsy
Official title: Pain Reduction by Forced Coughing During Colposcopy Guided Cervical Biopsies: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Cervical Dysplasia
Colposcopy
Pain Sensation
Cervical Biopsy
Keywords: cervical cancer
cervical dysplasia
cervical biopsy
pain
coughing
distraction
Lead sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).

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

Primary outcomes:
measure: Difference in pain between first and second biopsy
timeFrame: Immediately after the examination
Secondary outcomes:
measure: Pain perception before examination
timeFrame: Immediately before the start of the examination
measure: Pain perception when inserting the specula
timeFrame: Immediately after the insertion of the specula
measure: Pain perception when using acetic acid
timeFrame: Immediately after the application of acetic acid
measure: Pain perception at first biopsy
timeFrame: Immediately after the first biopsy was performed
measure: Pain perception at second biopsy
timeFrame: Immediately after the second biopsy was performed
measure: Pain perception just after examination
timeFrame: Immediately after the removal of the specula
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Zydolab - Institute of Cytology and Immune Cytochemistry
state: NRW
Study officials:
References: