跳至主要内容
临床试验/NCT00726635
NCT00726635Unknown3 期

Assessment of the Impact of Preoperative Stress Reduction on Psychological, Physiological and Immunological Parameters in Women With Gynecological Malignancies - Prospective Randomized Controlled Trial

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年8月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
60
试验地点
1
主要终点
psychological, physiological, immunological parameters

研究概览

简要总结

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

详细描述

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

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
None

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
否

入选标准

  • •Woman with ovarian, cervical or endometrial cancer/tumor
  • •Women who speak Hebrew
  • •Women who sign the consent form

排除标准

  • •Women who have received neoadjuvant treatment
  • •Women suffering from any form of depression, anxiety or schizophrenia
  • •Women suffering from autoimmune or infectious diseases
  • •Women taking medications which have immunological effects (steroids ,beta-blockers)
  • •Women suffering from dementia or concentration problems

研究组 & 干预措施

1

Active Comparator

Women in this arm will not receive a psychological intervention but rather will have a conversation with a nurse for one hour (attention control).

干预措施: Control group (Other)

2

Experimental

Cognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk)

干预措施: Cognitive intervention (Behavioral)

3

Experimental

Psycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery)

干预措施: psycho-physiological intervention (Other)

结局指标

主要结局

psychological, physiological, immunological parameters

时间窗: A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验