The Effects of Stress Reduction on Surgical Wound Healing

This study has been completed.
Sponsor:
Collaborator:
Health Research Council, New Zealand
Information provided by (Responsible Party):
Andrew G Hill, University of Auckland, New Zealand
ClinicalTrials.gov Identifier:
NCT00633737
First received: March 4, 2008
Last updated: December 19, 2013
Last verified: December 2013

March 4, 2008
December 19, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00633737 on ClinicalTrials.gov Archive Site
  • Plasma catecholamines [ Time Frame: morning of surgery, day after surgery, 7 days after surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • wound infection [ Time Frame: 7 days after surgery ] [ Designated as safety issue: No ]
  • self-rated recovery (including fatigue, pain) [ Time Frame: 7 days post-surgery ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT00633737
Wound healing study
No
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