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临床试验/NCT04845009
NCT04845009已完成不适用

The Effectiveness of Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers

Taipei Medical University0 个研究点目标入组 67 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
67
主要终点
Pain level change

研究概览

简要总结

This study aimed to investigate the effects of progressive muscle relaxation (PMR) on postoperative pain, fatigue, and vital signs in patients with head and neck cancers.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Head and neck cancer, need for surgery.
  • •(1) clear consciousness; (2) >= 20 years; (3) no history of surgery for head and neck cancer, regardless of cancer staging, tracheostomy tubing, degree of primary tumor resection, neck dissection, modified radical neck dissection, resection of cervical nerve root branches, and flap reconstruction (including free flap and transposition flap); (4) plan to undergo surgery; (5) willingness to participate in this study and provide informed consent; (6) physically capable of participation the study, as determined by the physician in charge; (7) ability to communicate in Mandarin or Taiwanese, with no reading, listening, or writing disability, and complete the questionnaire alone or with the assistance of the researchers.

排除标准

  • •Head and neck cancer, not for surgery.
  • •(1) use of hypnotics or record of a sleep disorder within 3 months prior to admission; (2) difficulty hearing, external auditory canal trauma, or hearing impairment; (3) diagnosis of a psychotic disorder or cognitive impairment; (4) experience practicing Jacobson's PMR.

研究组 & 干预措施

progressive muscle relaxation

Experimental

progressive muscle relaxation tape guided

干预措施: progressive muscle relaxation (Behavioral)

usual care

Placebo Comparator

usual care

干预措施: Usual care (Behavioral)

结局指标

主要结局

Pain level change

时间窗: preoperative day to postoperative day 10

The VAS (visual analog scale) score of pain levels, range 0-100, higher score means more severe symptoms.

muscle tightness level change

时间窗: preoperative day to postoperative day 10

The VAS (visual analog scale) score of muscle tightness levels, range 0-100, higher score means more severe symptoms.

Fatigue levels change

时间窗: preoperative day to postoperative day 10

The VAS (visual analog scale) score of fatigue levels, range 0-100, higher score means more severe symptoms.

次要结局

  • Heart rate change(preoperative day to postoperative day 10)
  • Systolic blood pressure change(preoperative day to postoperative day 10)
  • Diastolic blood pressure change(preoperative day to postoperative day 10)
  • Anxiety level(preoperative day to postoperative day 10)
  • depression level(preoperative day to postoperative day 10)
  • sleep disturbance level(preoperative day to postoperative day 10)

研究者

申办方类型
Other
责任方
Sponsor

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