Anxiety Related to Colposcopy and the Impact of Pre-colposcopy Intervention by a Clinical Nurse
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Université de Sherbrooke
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Pre-procedure situational anxiety
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 65 Years (Child, Adult, Older Adult)
- Sex
- Female
- Accepts 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.).
Arms & Interventions
Treatment as usual- No pre-procedure counseling about colposcopy
Call from the clinical nurse to schedule the appointment without counseling
Intervention: Treatment as usual: regular call to schedule the appointment without pre-procedure conseilling (Other)
Pre-colposcopy counseling from 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."
Intervention: Pre-colposcopy counseling by a clinical nurse (Other)
Outcomes
Primary Outcomes
Pre-procedure situational anxiety
Time Frame: 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 Outcomes
- Pain level perceived during the colposcopy procedure measured by a visual analog scale (VAS scale)(Immediately after the colposcopy procedure)
- Patient's satisfaction level(Immediately after the colposcopy procedure)
Investigators
Josianne Pare
Principal investigator, Doctor and Associate Professor at the Department of Obstetrics and Gynecology
Université de Sherbrooke