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Assessment of the Impact of Preoperative Stress Reduction on Psychological, Physiological and Immunological Parameters in Women With Gynecological Malignancies - Prospective Randomized Controlled Trial
The purpose of this study is to asses the impact of a tailored preoperative psychological intervention on women with gynecological malignancies on psychological, physiological and immunological parameters
Surgery is considered one of the most stressful events in human life. Research indicates that patients show high levels of stress from at least six days before surgery and up to a week post the operation. Stress levels return to normalcy only after several weeks. Research shows that psychological interventions given to women suffering from cancer can improve their coping abilities and overall function, decreases stress levels, enhances adherence to treatments,and increases quality of life and even life expectancy. Women enrolled in this study will be divided into two groups: an experimental group and a control group. Both groups will receive standard care. The control group will interact with a nurse for one hour. The experimental group will receive one of two forms of psychological intervention: either a cognitive intervention, or a psychophysiological intervention (tailored to each woman). Measurements and Instruments include: 1) Self-report questionnaires, such as:Profile of Mood States (POMS-SF),Coping Inventory (COPE), Life Orientation Test Revised (LOT- R),Stress Level Report, 2) Demographics, 3) Global assessment by the head nurse. 4)Physiological and behavioral measures, such as: vital signs and use of medicine. 5)Hormonal and immunological measures: levels of cortisol in saliva and plasma, levels of catecholamines in plasma, salivary levels of IgA1, and peripheral blood NK cells and lymphocyte phenotyping.6)levels of cytokines including IL-1,2,4,6,10,12, TNF-alpha, Interferon-gamma. Time intervals for the collection of blood and saliva and the administration of the questionnaires: During the first week after being given the diagnosis and prior to the intervention:Blood \& saliva, Stress Level Report, POMS-SF, COPE, LOT-R A day prior to surgery:Blood \& saliva, Stress Level Report On discharge from hospital:Blood \& saliva, Stress Level Report 30 days after surgery:Stress Level Report,POMS-SF,COPE,LOT-R.
Age
18 - 70 years
Sex
FEMALE
Healthy Volunteers
No
Rabin Medical center
Petah Tikva, Israel
Start Date
August 1, 2008
Primary Completion Date
August 1, 2009
Completion Date
August 1, 2009
Last Updated
February 17, 2009
60
ESTIMATED participants
Cognitive intervention
BEHAVIORAL
Control group
OTHER
psycho-physiological intervention
OTHER
Lead Sponsor
Rabin Medical Center
Collaborators
NCT05039801
NCT04550494
Data Source & Attribution
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