Colposcopy Anxiety and the Role of Pre-procedure Nursing Intervention

NCT ID: NCT07092189

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2025-07-14

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.

Conditions

Anxiety; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Treatment as usual- No pre-procedure counseling about colposcopy

Call from the clinical nurse to schedule the appointment without counseling

Group Type: SHAM_COMPARATOR

Treatment as usual: regular call to schedule the appointment without pre-procedure conseilling

Intervention Type: 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.

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."

Group Type: EXPERIMENTAL

Pre-colposcopy counseling by a clinical nurse

Intervention Type: 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."

Interventions

Pre-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."

Intervention Type: OTHER

Treatment 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.

Intervention Type: OTHER

Eligibility Criteria

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.).

• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Josianne Pare

Principal investigator, Doctor and Associate Professor at the Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josianne Paré, MD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Centre de recherche du CIUSS Estrie CHUS

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

2024-5032

Identifier Type: -

Identifier Source: org_study_id