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Colposcopy Anxiety and the Role of Pre-procedure Nursing Intervention

U

Université de Sherbrooke

Status and phase

Completed
Phase 3

Conditions

Anxiety
Pain

Treatments

Other: Pre-colposcopy counseling by a clinical nurse
Other: Treatment as usual: regular call to schedule the appointment without pre-procedure conseilling

Study type

Interventional

Funder types

Other

Identifiers

NCT07092189
2024-5032

Details and patient eligibility

About

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.

Enrollment

140 patients

Sex

Female

Ages

Under 65 years old

Volunteers

No Healthy Volunteers

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.).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

140 participants in 2 patient groups

Treatment as usual- No pre-procedure counseling about colposcopy
Sham Comparator group
Description:
Call from the clinical nurse to schedule the appointment without counseling
Treatment:
Other: Treatment as usual: regular call to schedule the appointment without pre-procedure conseilling
Pre-colposcopy counseling from a clinical nurse
Experimental group
Description:
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."
Treatment:
Other: Pre-colposcopy counseling by a clinical nurse

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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