|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
University of Auckland, New Zealand Health Research Council of New Zealand |
|---|---|
| Information provided by: | University of Auckland, New Zealand |
| ClinicalTrials.gov Identifier: | NCT00633737 |
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: | Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Single Group Assignment, Efficacy Study |
| Official Title: | The Effects of Stress Reduction on Surgical Wound Healing: A Randomised Controlled Trial |
| Estimated Enrollment: | 90 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
|
2: No Intervention
Standard care
|
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 |
Inclusion Criteria:
Contacts and Locations| Contact: Elizabeth Broadbent, PhD | +649 3737 599 ext 86756 | e.broadbent@auckland.ac.nz |
| New Zealand | |
| The University of Auckland | Recruiting |
| Auckland, New Zealand, 1001 | |
| Contact: Elizabeth A Broadbent, PhD +649 3737 599 ext 86756 e.broadbent@auckland.ac.nz | |
| Sub-Investigator: Andrew Hill, MBChB | |
| Sub-Investigator: Roger Booth, PhD | |
| Principal Investigator: | Elizabeth A Broadbent, PhD | The University of Auckland |
More Information
| Responsible Party: | Department of Psychological Medicine, University of Auckland ( Dr Elizabeth Broadbent ) |
| Study ID Numbers: | Wound healing study |
| Study First Received: | March 4, 2008 |
| Last Updated: | February 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00633737 History of Changes |
| Health Authority: | New Zealand: Health and Disability Ethics Committees |
|
Psychology Laparoscopy Cholecystectomy Psychoneuroimmunology Wound healing |
Preparation for surgery Stress reduction Stress Relaxation |
|
Stress |
|
Pathologic Processes Stress |
