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Colposcopy is essential for the diagnosis and prevention of cervical cancer. However, receiving screening results and being informed of the need to undergo a colposcopic examination are significant sources of anxiety for patients. This randomized controlled study aims to evaluate the impact of an intervention by a clinical nurse prior to a first colposcopy on patients' situational anxiety. Secondary objectives include patient satisfaction, perceived pain during the examination, and the exploration of sociodemographic factors related to anxiety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual- No pre-procedure counseling about colposcopy | Sham Comparator | Call from the clinical nurse to schedule the appointment without counseling |
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| Pre-colposcopy counseling from a clinical nurse | Experimental | In the intervention group, the clinical nurse conducted a structured pre-colposcopy counseling session covering the following topics: verification of the patient's understanding of the reason for the colposcopy referral, explanation of the cervical cytology result, the procedure of the colposcopy, expectations regarding pain, the role of HPV in the development of precancerous and cancerous cervical lesions, counseling on HPV vaccination, and smoking cessation." |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-colposcopy counseling by a clinical nurse | Other | In the intervention group, the clinical nurse conducted a structured pre-colposcopy counseling session covering the following topics: verification of the patient's understanding of the reason for the colposcopy referral, explanation of the cervical cytology result, the procedure of the colposcopy, expectations regarding pain, the role of HPV in the development of precancerous and cancerous cervical lesions, counseling on HPV vaccination, and smoking cessation." |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-procedure situational anxiety | The pre-procedure situational anxiety is measured on the day of the colposcopy using the State Trait Anxiety Inventory (STAI). The STAI is a validated 20 item self report assessment device which includes separate measures of state and trait anxiety. The minimum value is 20 and the maximum value is 80. Higher scores indicate greater anxiety. | On the day of the colposcopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pain level perceived during the colposcopy procedure measured by a visual analog scale (VAS scale) | We measured the pain level perceived during the colposcopy procedure using a visual analog scale ranging from 0 to 10. Highest scores indicated higher level of pain perceived during the procedure. | Immediately after the colposcopy procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josianne Paré, MD | Université de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche du CIUSS Estrie CHUS | Sherbrooke | Quebec | J1H 5N4 | Canada |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual: regular call to schedule the appointment without pre-procedure conseilling | Other | In the control group, patients simply received a phone call to notify them of their appointment and, upon arrival, were given an information sheet about colposcopy. No pre-colposcopy discussion was conducted. |
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| Patient's satisfaction level |
Patient satisfaction levels were assessed using the standardized Patient's Experience and Attitude Colposcopy Eindhoven Questionnaire (PEACE-q). It is a validated 8-item user-friendly self-rating tool with with questions on: level of being informed, preoccupation, level of stress and level of ease created during consultation. The 8 items are rated on a 4-point Likert scale (final scores ranging from 8 to 32). Higher scores indicate a more positive experience of the colposcopy procedure. |
| Immediately after the colposcopy procedure |