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临床试验/NCT06224504
NCT06224504已完成不适用

Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients With Non-Small Cell Lung Cancer

Shanxi Bethune Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
SAS score

研究概览

简要总结

This study is to assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC).The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.

详细描述

To assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC). A total of 60 lung cancer patients from a hospital in Shanxi Province were selected using convenience sampling and divided into an intervention group and a control group, with 30 patients in each group. The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. The two group were evaluated by the questionnaire three times. One day before the intervention, the first questionnaire was conducted, and the basic data of the two groups of patients were collected. The second questionnaire evaluation of anxiety, depression, sleep quality, and the Brief Symptom Rating Scale (BSRS-5) was conducted 6 weeks after the end of the intervention, and the third questionnaire evaluation was conducted 8 weeks after the end of the intervention to evaluate the intervention effect of the two groups. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.

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
Single (Participant)

入排标准

年龄范围
44 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients diagnosed with non-small cell lung cancer
  • patients aged between 20 and 74 years, without gender limitation
  • a score of 4-14 on the Short Symptom Rating Scale (BSRS-5)
  • a clinical prognosis of at least 6 months
  • clear consciousness, good functional ability, and unrestricted language communication
  • written informed consent provided by the patient

排除标准

  • patients with severe physical illnesses or symptoms that impede learning and are considered life-threatening
  • patients with a BSRS-5 assessment score > 15 and suicidal ideation > 2
  • patients unable to accurately describe their symptoms
  • patients with limited cooperation ability
  • patients who have previously undergone MBSR or other positive-thinking-focused psychotherapy methods

结局指标

主要结局

SAS score

时间窗: at 8 weeks after the intervention

Self-Rating Anxiety Scale (SAS)

SDS score

时间窗: at 8 weeks after the intervention

Self-Rating Depression Scale (SDS)

BSRS-5 score

时间窗: at 8 weeks after the intervention

the five-item Brief Symptom Rating Scale (BSRS-5)

PSQI score

时间窗: at 8 weeks after the intervention

Pittsburgh Sleep Quality Index (PSQI)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wanling Li

Principal Investigator

Shanxi Bethune Hospital

研究点 (1)

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