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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Wound Healing Stress Surgery Behavioral: Stress reduction intervention

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Stress Reduction on Surgical Wound Healing: A Randomised Controlled Trial
Study Start Date : March 2008
Primary Completion Date : May 2010
Study Completion Date : December 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Plasma catecholamines [ Time Frame: morning of surgery, day after surgery, 7 days after surgery ]
  2. 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 ]
  3. wound infection [ Time Frame: 7 days after surgery ]
  4. self-rated recovery (including fatigue, pain) [ Time Frame: 7 days post-surgery ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

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


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
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: December 2013

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

Additional relevant MeSH terms:
Wounds and Injuries
Surgical Wound