Anxiety Related to Colposcopy and the Impact of Pre-colposcopy Intervention by a Clinical Nurse
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Pre-procedure situational anxiety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •People with a cervix
- •21-65 years old
- •Speaking French
- •Abnormal pap smears warranting a colposcopy
排除标准
- •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.).
研究组 & 干预措施
Treatment as usual- No pre-procedure counseling about colposcopy
Call from the clinical nurse to schedule the appointment without counseling
干预措施: Treatment as usual: regular call to schedule the appointment without pre-procedure conseilling (Other)
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."
干预措施: Pre-colposcopy counseling by a clinical nurse (Other)
结局指标
主要结局
Pre-procedure situational anxiety
时间窗: 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.
次要结局
- 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)
研究者
Josianne Pare
Principal investigator, Doctor and Associate Professor at the Department of Obstetrics and Gynecology
Université de Sherbrooke