The Effects of Stress Reduction on Surgical Wound Healing

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633737
• Other study ID #: Wound healing study
• Status: Completed
• Phase: N/A
• First received: March 4, 2008
• Last updated: December 19, 2013
• Start date: March 2008
• Est. completion date: December 2010

Study information

• Verified date: December 2013
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• planned elective laparoscopic cholecystectomy at Manukau Surgical Centre

• able to understand English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress
• Surgery
• Wound Healing

Intervention

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.

Locations

Country	Name	City	State
New Zealand	The University of Auckland	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
University of Auckland, New Zealand	Health Research Council, New Zealand

Country where clinical trial is conducted

New Zealand, 

References & Publications (2)

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. — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	expanded polytetrafluoroethylene (ePTFE) tubes assessed for hydroxyproline deposited per unit length of the tube as well as total protein		7 days following surgery	No
Secondary	Plasma catecholamines		morning of surgery, day after surgery, 7 days after surgery	No
Secondary	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	No
Secondary	wound infection		7 days after surgery	No
Secondary	self-rated recovery (including fatigue, pain)		7 days post-surgery	No