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
  Purpose

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.


Condition Intervention
Wound Healing
Stress
Surgery
Behavioral: Stress reduction intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Stress Reduction on Surgical Wound Healing: A Randomised Controlled Trial

Further study details as provided by University of Auckland, New Zealand:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 70
Study Start Date: March 2008
Study Completion Date: December 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Stress reduction 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.
No Intervention: 2
Standard care

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • planned elective laparoscopic cholecystectomy at Manukau Surgical Centre
  • able to understand English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633737

Locations
New Zealand
The University of Auckland
Auckland, New Zealand, 1001
Sponsors and Collaborators
University of Auckland, New Zealand
Health Research Council, New Zealand
Investigators
Principal Investigator: Elizabeth A Broadbent, PhD The University of Auckland
  More Information

Publications:
Responsible Party: Andrew G Hill, Professor, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT00633737     History of Changes
Other Study ID Numbers: Wound healing study
Study First Received: March 4, 2008
Last Updated: December 19, 2013
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by University of Auckland, New Zealand:
Psychology
Laparoscopy
Cholecystectomy
Psychoneuroimmunology
Wound healing
Preparation for surgery
Stress reduction
Stress
Relaxation

ClinicalTrials.gov processed this record on October 19, 2014