The Effects of Stress Reduction on Surgical Wound Healing
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|ClinicalTrials.gov Identifier: NCT00633737|
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : December 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Wound Healing Stress Surgery||Behavioral: Stress reduction intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Stress Reduction on Surgical Wound Healing: A Randomised Controlled Trial|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||December 2010|
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
- 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 ]
- Plasma catecholamines [ Time Frame: morning of surgery, day after surgery, 7 days after surgery ]
- 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 ]
- wound infection [ Time Frame: 7 days after surgery ]
- self-rated recovery (including fatigue, pain) [ Time Frame: 7 days post-surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633737
|The University of Auckland|
|Auckland, New Zealand, 1001|
|Principal Investigator:||Elizabeth A Broadbent, PhD||The University of Auckland|