Colposcopy Anxiety and the Role of Pre-procedure Nursing Intervention

NCT07092189 | Completed Phase 3

• 1 other identifier: 2024-5032
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

Treatment as usual- No pre-procedure counseling about colposcopy

SHAM COMPARATOR

Call from the clinical nurse to schedule the appointment without counseling

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

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."

Other: Pre-colposcopy counseling by a clinical nurse

Interventions

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."

Pre-colposcopy counseling from a clinical nurse

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.

Treatment as usual- No pre-procedure counseling about colposcopy

Eligibility Criteria

• Age: Up to 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• People with a cervix
• years old
• Speaking French
• Abnormal pap smears warranting a colposcopy

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de recherche du CIUSS Estrie CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Josianne Paré, MD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Doctor and Associate Professor at the Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 29, 2025
• Study Start: January 8, 2024
• Primary Completion: December 8, 2024
• Study Completion: July 14, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)