JOURNAL ONKOLOGIE – STUDIE

Coughing at Time of Cervical Biopsy

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06149598

Studienbeginn:
Januar 2024

Letztes Update:
05.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Cough

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Zydolab - Institute of Cytology and Immune Cytochemistry

Collaborator:
-

Studienlocations
(1 von 1)

Zydolab - Institute of Cytology and Immune Cytochemistry
44137 Dortmund
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ziad Hilal, M.D.
Phone: +0049 231 579349
E-Mail: z.hilal@zydolab.de» Ansprechpartner anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Difference in pain between first and second biopsy (Time Frame - Immediately after the examination):
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.

Secondary outcome:

1. Pain perception before examination (Time Frame - Immediately before the start of the examination):
the patients' perception of pain before examination, 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.

2. Pain perception when inserting the specula (Time Frame - Immediately after the insertion of the specula):
the patients' perception of pain at the moment of the insertion of the specula, 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.

3. Pain perception when using acetic acid (Time Frame - Immediately after the application of acetic acid):
the patients' perception of pain at the moment of the application of acetic acid, 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.

4. Pain perception at first biopsy (Time Frame - Immediately after the first biopsy was performed):
the patients' perception of pain during the first biopsy, 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.

5. Pain perception at second biopsy (Time Frame - Immediately after the second biopsy was performed):
the patients' perception of pain during the second biopsy, 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.

6. Pain perception just after examination (Time Frame - Immediately after the removal of the specula):
the patients' perception of pain just after finishing the examination, 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.

Studien-Arme

Experimental: Coughing at the time of first biopsy
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.
Active Comparator: Coughing at the time of second biopsy
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.

Geprüfte Regime

Coughing at the time of biopsy:
Patients are asked to cough or not to cough during cervical biopsy.

Quelle: ClinicalTrials.gov

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