Anxiety, Pain
Conditions
Brief summary
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.
Interventions
OTHERPre-colposcopy counseling by a clinical nurse
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.
OTHERTreatment as usual: regular call to schedule the appointment without pre-procedure conseilling
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.
Sponsors
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 65 Years
Healthy volunteers
No
Inclusion criteria
* People with a cervix * 21-65 years old * Speaking French * Abnormal pap smears warranting a colposcopy
Exclusion criteria
* Refusal to participate * Inability to provide consent. * Having previously undergone a colposcopy. * Being pregnant * Having a reason for consultation other than an abnormal cytology result (such as VIN, VAIN, suspected cancer, vulvar dermatological issues, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-procedure situational anxiety | On the day of the colposcopy procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain level perceived during the colposcopy procedure measured by a visual analog scale (VAS scale) | Immediately after the colposcopy procedure | 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. |
| Patient's satisfaction level | Immediately after the colposcopy procedure | 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. |
Countries
Canada
Outcome results
None listed