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Trial Title:
Management With Fear of Cancer in Women Undergoing Colposcopy: Randomized Controlled Study
NCT ID:
NCT06263062
Condition:
Cancer Fear
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
fear of cancer
MBSR
nursing
awareness
cervical cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Awareness-Based Coping with Fear of Cancer Programme
Description:
The content of the Training Program was created by researchers based on MBSR, in line
with high-level research results and international guides.Then, the necessary
arrangements were made bytaking the opinions of 10 experts ( faculty members of the
department of obstetrics and gynaecology nursing, psychiatry specialist, faculty members
of the gynaecology oncology department, oncology clinic psychologist, obstetrics and
gynaecology clinic charge nurse). Content concluded in accordance with the comments
received.
Arm group label:
Experimental group
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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,
Exclusion Criteria:
- 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
Gender:
Female
Gender based:
Yes
Gender description:
women
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Alanya Alaaddin Keykubat University
Address:
City:
Alanya
Zip:
7400
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
fatma ozlem uner, MSc
Phone:
+905062972749
Email:
fatma.uner@alanya.edu.tr
Start date:
January 7, 2021
Completion date:
June 15, 2024
Lead sponsor:
Agency:
Alanya Alaaddin Keykubat University
Agency class:
Other
Source:
Alanya Alaaddin Keykubat University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06263062
