The Effects of Stress Reduction on Surgical Wound Healing
NCT ID: NCT00633737
Last Updated: 2013-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2008-03-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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1
Stress reduction intervention
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
Standard care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* able to understand English
18 Years
80 Years
ALL
No
Sponsors
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Health Research Council, New Zealand
OTHER
University of Auckland, New Zealand
OTHER
Responsible Party
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Andrew G Hill
Professor
Principal Investigators
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Elizabeth A Broadbent, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Auckland
Locations
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The University of Auckland
Auckland, , New Zealand
Countries
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References
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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.
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.
Other Identifiers
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Wound healing study
Identifier Type: -
Identifier Source: org_study_id