Clinical trial NCT00633737: The Effects of Stress Reduction on Surgical Wound Healing
Official title: The Effects of Stress Reduction on Surgical Wound Healing: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing
Stress
Surgery
Keywords: Psychology
Laparoscopy
Cholecystectomy
Psychoneuroimmunology
Wound healing
Preparation for surgery
Stress reduction
Stress
Relaxation
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
Collaborators: name: Health Research Council, New Zealand
First posted: 2008-03-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: expanded polytetrafluoroethylene (ePTFE) tubes assessed for hydroxyproline deposited per unit length of the tube as well as total protein
timeFrame: 7 days following surgery
Secondary outcomes:
measure: Plasma catecholamines
timeFrame: morning of surgery, day after surgery, 7 days after surgery
measure: Salivary cortisol
timeFrame: on morning before surgery (one sample). on day after surgery: samples immediately after waking, after 15 minutes, after 30 minutes and after 60 minutes
measure: wound infection
timeFrame: 7 days after surgery
measure: self-rated recovery (including fatigue, pain)
timeFrame: 7 days post-surgery
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: The University of Auckland
Study officials:
affiliation: The University of Auckland
name: Elizabeth A Broadbent, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Broadbent E, Kahokehr A, Booth RJ, Thomas J, Windsor JA, Buchanan CM, Wheeler BR, Sammour T, Hill AG. A brief relaxation intervention reduces stress and improves surgical wound healing response: a randomised trial. Brain Behav Immun. 2012 Feb;26(2):212-7. doi: 10.1016/j.bbi.2011.06.014. Epub 2011 Jun 28.
citation: Kahokehr A, Broadbent E, Wheeler BR, Sammour T, Hill AG. The effect of perioperative psychological intervention on fatigue after laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2012 Jun;26(6):1730-6. doi: 10.1007/s00464-011-2101-7. Epub 2012 Jan 19.