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The Effects of Stress Reduction on Surgical Wound Healing

Primary Purpose

Wound Healing, Stress, Surgery

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Stress reduction intervention
Sponsored by
University of Auckland, New Zealand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing focused on measuring Psychology, Laparoscopy, Cholecystectomy, Psychoneuroimmunology, Wound healing, Preparation for surgery, Stress reduction, Stress, Relaxation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • The University of Auckland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Stress reduction intervention

Standard care

Outcomes

Primary Outcome Measures

expanded polytetrafluoroethylene (ePTFE) tubes assessed for hydroxyproline deposited per unit length of the tube as well as total protein

Secondary Outcome Measures

Plasma catecholamines
Salivary cortisol
wound infection
self-rated recovery (including fatigue, pain)

Full Information

First Posted
March 4, 2008
Last Updated
December 19, 2013
Sponsor
University of Auckland, New Zealand
Collaborators
Health Research Council, New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT00633737
Brief Title
The Effects of Stress Reduction on Surgical Wound Healing
Official Title
The Effects of Stress Reduction on Surgical Wound Healing: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Auckland, New Zealand
Collaborators
Health Research Council, New Zealand

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing, Stress, Surgery
Keywords
Psychology, Laparoscopy, Cholecystectomy, Psychoneuroimmunology, Wound healing, Preparation for surgery, Stress reduction, Stress, Relaxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Stress reduction intervention
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
Stress reduction intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Plasma catecholamines
Time Frame
morning of surgery, day after surgery, 7 days after surgery
Title
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
Title
wound infection
Time Frame
7 days after surgery
Title
self-rated recovery (including fatigue, pain)
Time Frame
7 days post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: planned elective laparoscopic cholecystectomy at Manukau Surgical Centre able to understand English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Broadbent, PhD
Organizational Affiliation
The University of Auckland
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Auckland
City
Auckland
ZIP/Postal Code
1001
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
21741471
Citation
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.
Results Reference
result
PubMed Identifier
22258294
Citation
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.
Results Reference
result

Learn more about this trial

The Effects of Stress Reduction on Surgical Wound Healing

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