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Clinical Trials/NCT00633737
NCT00633737
Completed
Not Applicable

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

University of Auckland, New Zealand1 site in 1 country70 target enrollmentMarch 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Wound Healing
Sponsor
University of Auckland, New Zealand
Enrollment
70
Locations
1
Primary Endpoint
expanded polytetrafluoroethylene (ePTFE) tubes assessed for hydroxyproline deposited per unit length of the tube as well as total protein
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
December 2010
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Auckland, New Zealand
Responsible Party
Principal Investigator
Principal Investigator

Andrew G Hill

Professor

University of Auckland, New Zealand

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 7 days following surgery

Secondary Outcomes

  • 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)

Study Sites (1)

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