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To investigate the effect of coughing as an intervention to reduce pain in colposcopy guided biopsy.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coughing at the time of biopsy | Behavioral | Patients are asked to cough or not to cough during cervical biopsy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain perception before 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zydolab - Institute of Cytology and Immune Cytochemistry | Dortmund | North Rhine-Westphalia | 44137 | Germany |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| D010146 | Pain |
| D003371 | Cough |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Immediately before the start of the examination |
| Pain perception when inserting 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. | Immediately after the insertion of the specula |
| Pain perception when using 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. | Immediately after the application of acetic acid |
| Pain perception at first biopsy | 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. | Immediately after the first biopsy was performed |
| Pain perception at second biopsy | 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. | Immediately after the second biopsy was performed |
| Pain perception just after examination | 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. | Immediately after the removal of the specula |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |