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临床试验/NCT07090915
NCT07090915尚未招募不适用

Evaluating the Impact of Nature Soundscapes on Post-Operative Stress and Anxiety in Orthopedic Surgery Patients

Michael Tobias Hirschmann1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年8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
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Depressions-Angst-Stress-Skalen (DASS-21)

研究概览

简要总结

For many people, a stay in hospital can be associated with stress and anxiety, especially after surgery. In order to potentially make the stay more pleasant for patients in future, the investigators are conducting a study to investigate the use of natural sounds to promote relaxation. Participation in this study usually lasts until 3 days after the operation in hospital. If the participants decide to take part, the participants will be randomly assigned to one of two groups: The intervention group or the control group. In the intervention group, the participants will listen to different natural sounds twice a day. In the control group, the participants will not receive any nature sounds. During the stay, the participants will be given two questionnaires to fill in about how you feel. Participants assigned to the intervention group will additionallyreceive a short telephone interview 14 days after the operation.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •duly completed declaration of consent
  • •the age of the patient is at least 18 years
  • •only patients undergoing orthopaedic surgery

排除标准

  • •severe cognitive impairment
  • •chronic pain patient
  • •pain catheter insertion during the trial period
  • •psychiatric disorders (e.g. anxiety disorders, depression, post-traumatic stress disorder, ...)
  • •severe postoperative complications
  • •no consent to participate

研究组 & 干预措施

control group

No Intervention

standard hospital stay

Intervention group

Experimental

干预措施: nature sound (Other)

结局指标

主要结局

Depressions-Angst-Stress-Skalen (DASS-21)

时间窗: From the first day after surgery until the third day after surgery.

0 to 63 (0 is best 63 is bad)

次要结局

  • NRS, to measure the sleep quality(From the first day after the surgery to the third day after the surgery.)
  • Relaxation State Questionnaire (RSQ), to measure the Relaxation(From the first day after the surgery to the third day after the surgery.)
  • NRS, to measure the Painlevel(From the first day after the surgery to the third day after the surgery.)

研究者

发起方
Michael Tobias Hirschmann
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael Tobias Hirschmann

Prof. Dr. med.

Kantonsspital Baselland Bruderholz

研究点 (1)

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