The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Effect of methods of self-regulation of mental state on postoperative pain perception changes
研究概览
简要总结
In this study, it will be investigated whether the methods of self-regulation of mental state have an effect on postoperative pain perception in colon cancer patients.
详细描述
According to the assumptions of psychoneuroimmunology, the improvement of mental state affects the physical improvement of patients. Numerous studies confirm the effectiveness of hypnosis and learning autohypnosis in improving the functioning of patients in terms of reducing pain and anxiety, improving the quality of sleep and mood. The study is a Prospective Randomized Controlled Trial consisting of two groups. Patients in the study group will receive a voice recording with hypnotic instructions with a suggestion to improve the psychophysical state. Patients in the control group will receive a recording with relaxing music. Depending on the randomization, patients will listen to the selected recording before being admitted to the surgical department. They will then be given a recording to listen to whenever they want. The patients will be examined four times using the Activity Change Scale, ie. before randomization, on the first day after surgery, on the 7th day after surgery and 1 month after surgery. Simultaneously the total analgesic consumption will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent to participate in the study
- •Age >= 18 years
- •Histopathological diagnosis of primary colon cancer without distant metastasis
- •Planned surgical treatment
- •Fluency in Polish
排除标准
- •Severe comorbidities with pain disorders
- •Regular use of analgesics
- •Coexistence of another neoplastic disease
- •Use of non-pharmacological pain management (including autohypnosis) prior to the study
- •Poor general condition
- •Previous colorectal surgery
- •Hearing disorders
- •No possibility of playback of the received recording
结局指标
主要结局
Effect of methods of self-regulation of mental state on postoperative pain perception changes
时间窗: The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery.
The timing of primary outcome measurement includes more than one time point because outcome measurements assess changes in patient status. The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery. The measure will assess the condition over the last 24 hours on scales ranging from -10 to +10 of the Activity Change Scale. For pain, the score will be reviewed by asking: 1. Which bodily sensations predominate at the site of the illness? A score of -10 indicates maximal relief; 0 neutral condition; and +10 indicates maximal pain. For all answers, higher scores mean a worse outcome.
次要结局
- Effect of methods of self-regulation of mental state on mood changes(The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery.)
- Effect of methods of self-regulation of mental state on anxiety changes(The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery.)