Cervical Biopsy, Cervical Cancer, Cervical Dysplasia, Colposcopy, Pain Sensation
Conditions
Keywords
cervical cancer, cervical dysplasia, cervical biopsy, pain, coughing, distraction
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).
Interventions
BEHAVIORALCoughing at the time of biopsy
Patients are asked to cough or not to cough during cervical biopsy.
Sponsors
Zydolab - Institute of Cytology and Immune Cytochemistry
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in pain between first and second biopsy | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain perception before examination | 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. |
| Pain perception when using acetic acid | 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. |
| Pain perception when inserting the specula | 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. |
| Pain perception at second biopsy | 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. |
| Pain perception just after examination | 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. |
| Pain perception at first biopsy | 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. |
Countries
Germany
Outcome results
None listed