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临床试验/NCT00633737
NCT00633737已完成不适用

The Effects of Stress Reduction on Surgical Wound Healing: A Randomised Controlled Trial

University of Auckland, New Zealand2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2008年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
expanded polytetrafluoroethylene (ePTFE) tubes assessed for hydroxyproline deposited per unit length of the tube as well as total protein

研究概览

简要总结

The purpose of this study is to investigate whether a stress reduction intervention prior to surgery can improve wound healing and recovery.The investigators hypothesise that patients who receive a psychological stress reduction intervention prior to surgery will report lower stress and higher perceived control, have lower stress hormones, better wound healing and better self-reported recovery than patients who receive standard care alone.

详细描述

In previous prospective research, psychological stress has been shown to slow the healing of small superficial wounds and impair surgical healing. We will investigate whether a psychological intervention to reduce stress can improve surgical healing.

Ninety patients undergoing elective laparoscopic cholecystectomy will be randomised to receive either standard care or a brief pre-surgical psychological intervention plus standard care. Patients will complete a pre-surgical questionnaire to assess stress, anxiety, depression, illness perceptions and current health, at least 3 days prior to surgery. Then the intervention will be delivered. A second questionnaire on the morning of surgery will reassess stress, anxiety and illness perceptions to see whether the intervention has reduced stress and increased control perceptions. Plasma catecholamines and salivary cortisol will be tested to assess the effectiveness of the intervention in reducing stress-related hormones and to investigate their role in wound healing. During surgery 2 small expanded polytetrafluroethylene tubes will be inserted in the wound, which will be removed after 7 days. Wound healing will be assessed by hydroxyproline and total protein deposition in the tubes, as well as by the presence of wound infection. Patients' post-surgical recovery, including pain and fatigue, will also be assessed. If this brief psychological intervention can improve wound healing and aid recovery, it would provide a simple strategy to improve outcomes in surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • planned elective laparoscopic cholecystectomy at Manukau Surgical Centre
  • able to understand English

排除标准

  • 未提供

结局指标

主要结局

expanded polytetrafluoroethylene (ePTFE) tubes assessed for hydroxyproline deposited per unit length of the tube as well as total protein

时间窗: 7 days following surgery

次要结局

  • Plasma catecholamines(morning of surgery, day after surgery, 7 days after surgery)
  • Salivary cortisol(on morning before surgery (one sample). on day after surgery: samples immediately after waking, after 15 minutes, after 30 minutes and after 60 minutes)
  • wound infection(7 days after surgery)
  • self-rated recovery (including fatigue, pain)(7 days post-surgery)

研究者

发起方
University of Auckland, New Zealand
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew G Hill

Professor

University of Auckland, New Zealand

研究点 (2)

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