Skip to main content
OpenTrials
Completed

NCT Number: NCT07092189

Colposcopy Anxiety and the Role of Pre-procedure Nursing Intervention

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centre de recherche du CIUSS Estrie CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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."

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.

Primary outcomes

  1. 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

  1. Pain level perceived during the colposcopy procedure measured by a visual analog scale (VAS scale)

    Time frame: 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.

  2. Patient's satisfaction level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

Anxiety Related to Colposcopy and the Impact of Pre-colposcopy Intervention by a Clinical Nurse

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.