跳至主要内容
临床试验/NCT06263062
NCT06263062Unknown不适用

Impact of the Awareness-Based Initiation Program on Cancer Fear and Awareness Level in Women Undergoing Colposcopy: Randomized Controlled Study

Alanya Alaaddin Keykubat University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2021年1月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
The Cancer Worry Scale

研究概览

简要总结

Cervical cancer is the fourth most common cancer in women worldwide. Due to advances in early diagnosis and treatment, the number of survivors of cancer has increased over the past 50 years. Therefore, the current standard of care for the detection of cervical neoplasm, a Papanicolaou smear and then a colposcopic biopsy, requires a high degree of diagnostic accuracy. In particular, the fear of developing cancer after cancer screening tests is becoming an increasingly significant problem, with an impact on psychosocial health in individuals. For people who are afraid of cancer, meditation and awareness training can make it easier for emotions to self-regulate in times of distress and pain. This study aim to conducted to determine the impact of the Awareness-Based Initiation Program on cancer fear and level of awareness in women undergoing colonoscopy.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Colposcopy procedure due to HSIL, LSIL, ASC-H or HPV on cervical cytology
  • Volunteering to participate in the 6-session Mindfulness-Based Coping Programme Knowing what a colposcopy procedure means,

排除标准

  • interference with verbal communication,
  • being diagnosed with major depressive disorder or psychiatric disorder,
  • having participated in MBSR training or meditating before
  • Lack of skills to use smart phones and computers
  • learning biopsy results during the programme

研究组 & 干预措施

Control group

No Intervention

routine care after a colopscopy procedure Routine care will be provided by the nurse training handbook created by the researcher

Experimental group

Experimental

routine care after a colopscopy procedure "Mindfulness-Based Coping Programme" in addition to routine care Prepared in accordance with the MBSR programme. Applied online with Zoom programme Teams in groups of 6 people 6 sessions in 2 weeks

干预措施: Awareness-Based Coping with Fear of Cancer Programme (Behavioral)

结局指标

主要结局

The Cancer Worry Scale

时间窗: This scale will be administered twice: pre-intervention and immediately after the intervention

The Cancer Worry Scale was developed by Custers et al. (2014) and consists of 8 items. In the Likert scale, the responses are numbered from 0 to 4. In the scale, 0 is expressed as "almost never", while 4 is expressed as "almost always". In the scoring of the scale, the lowest score is 0 and the highest score is 32. Cronbach's alpha value was determined as 0.87.

次要结局

  • Philadelphia Mindfulness Scale(This scale will be administered twice: pre-intervention and immediately after the intervention)

研究者

发起方
Alanya Alaaddin Keykubat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Ozlem Uner

Research Assistant

Alanya Alaaddin Keykubat University

研究点 (2)

Loading locations...

相似试验

Management With Fear of Cancer in Women Undergoing... | 临床试验