AnxietyPhase 3NCT07092189
Colposcopy Anxiety and the Role of Pre-procedure Nursing Intervention
A Phase 3 study testing Pre-colposcopy counseling by a clinical nurse and Treatment as usual: regular call to schedule the appointment without pre-procedure conseilling in people with Anxiety and Pain, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 65 years, women only
- What is being tested?
- Pre-colposcopy counseling by a clinical nurse and Treatment as usual: regular call to schedule the appointment without pre-procedure conseilling
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2024to 14 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- People with a cervix
- 21-65 years old
- Speaking French
- Abnormal pap smears warranting a colposcopy
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche du CIUSS Estrie CHUS
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Anxiety Related to Colposcopy and the Impact of Pre-colposcopy Intervention by a Clinical Nurse
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.
- Being tested
- Pre-colposcopy counseling by a clinical nurse, Treatment as usual: regular call to schedule the appointment without pre-procedure conseilling
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-colposcopy counseling by a clinical nurseOther
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 conseillingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual- No pre-procedure counseling about colposcopy | Sham comparator | Call from the clinical nurse to schedule the appointment without counseling Receives: 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." Receives: Other: Pre-colposcopy counseling by a clinical nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Immediately after the colposcopy procedure
Patient's satisfaction level
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.
Measured: Immediately after the colposcopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start8 Jan 2024
- Primary completion8 Dec 2024
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josianne Pare, Université de Sherbrooke
- Investigators
- Josianne Paré, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092189
- Sponsor's protocol ID
- 2024-5032
- Status last verified
- Jul 2025
- First submitted
- 19 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety Related to Colposcopy and the Impact of Pre-colposcopy Intervention by a Clinical Nurse
- ClinicalTrials.gov ID
- NCT07092189
- Acronym / sponsor ID
- 2024-5032
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 8 Dec 2024 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual- No pre-procedure counseling about colposcopy | Sham comparator | Other: Treatment as usual: regular call to schedule the appointment without pre-procedure conseillingCall from the clinical nurse to schedule the appointment without counseling |
| Pre-colposcopy counseling from a clinical nurse | Experimental | Other: Pre-colposcopy counseling by a clinical nurseIn 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." |
Who may qualify
- Ages
- Up to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- People with a cervix
- 21-65 years old
- Speaking French
- Abnormal pap smears warranting a colposcopy
Key exclusion criteria (5 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-colposcopy counseling by a clinical nurseIn 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 from a clinical nurse |
| Treatment as usual: regular call to schedule the appointment without pre-procedure conseillingIn 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. | Other | Treatment as usual- No pre-procedure counseling about colposcopy |
Primary outcome
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.
2 secondary outcomes
Pain level perceived during the colposcopy procedure measured by a visual analog scale (VAS scale)
Time frame: Immediately after the colposcopy procedure
Patient's satisfaction level
Time frame: Immediately after the colposcopy procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josianne Paré, MD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pre-colposcopy counseling by a clinical nurse and Treatment as usual: regular call to schedule the appointment without pre-procedure conseilling in people with Anxiety and Pain, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-procedure situational anxiety (time frame: On the day of the colposcopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.