The Effects of Stress Reduction on Surgical Wound Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00633737
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : December 23, 2013
Health Research Council, New Zealand
Information provided by (Responsible Party):
Andrew G Hill, University of Auckland, New Zealand

March 4, 2008
March 12, 2008
December 23, 2013
March 2008
May 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00633737 on Archive Site
  • Plasma catecholamines [ Time Frame: morning of surgery, day after surgery, 7 days after surgery ]
  • Salivary cortisol [ Time Frame: 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 [ Time Frame: 7 days after surgery ]
  • self-rated recovery (including fatigue, pain) [ Time Frame: 7 days post-surgery ]
Same as current
Not Provided
Not Provided
The Effects of Stress Reduction on Surgical Wound Healing
The Effects of Stress Reduction on Surgical Wound Healing: A Randomised Controlled Trial
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Wound Healing
  • Stress
  • Surgery
Behavioral: Stress reduction intervention
In addition to standard care, patients in the intervention group will receive a one-hour individually delivered programme administered once by a psychologist at least 3 days prior to surgery. This session aims to reduce stress and involves teaching relaxation and guided imagery exercises. Patients are provided a CD (or audiotape)of the relaxation instructions to take home and practice once a day.
  • Experimental: 1
    Stress reduction intervention
    Intervention: Behavioral: Stress reduction intervention
  • No Intervention: 2
    Standard care

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • planned elective laparoscopic cholecystectomy at Manukau Surgical Centre
  • able to understand English
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
New Zealand
Wound healing study
Not Provided
Not Provided
Andrew G Hill, University of Auckland, New Zealand
University of Auckland, New Zealand
Health Research Council, New Zealand
Principal Investigator: Elizabeth A Broadbent, PhD The University of Auckland
University of Auckland, New Zealand
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP