The Effects of Stress Reduction on Surgical Wound Healing

NCT00633737 | Completed

• 1 other identifier: Wound healing study
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Healing; Stress; Surgery

Keywords

Psychology; Laparoscopy; Cholecystectomy; Psychoneuroimmunology; Wound healing; Preparation for surgery; Stress reduction; Stress; Relaxation

Outcome Measures

Primary Outcomes (1)

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

  7 days following surgery

Secondary Outcomes (4)

• 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 Arms (2)

1

EXPERIMENTAL

Stress reduction intervention

Behavioral: Stress reduction intervention

2

NO INTERVENTION

Standard care

Interventions

Stress reduction intervention BEHAVIORAL

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.

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Auckland, New Zealand: lead
• Health Research Council, New Zealand: collaborator

Study Sites (1)

The University of Auckland

Auckland, 1001, New Zealand

Location

Related 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. doi: 10.1016/j.bbi.2011.06.014. Epub 2011 Jun 28.

  PMID: 21741471 RESULT

• 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.

  PMID: 22258294 RESULT

Study Officials

• Elizabeth A Broadbent, PhD

  The University of Auckland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

NZ (1)