The Effects of Stress Reduction on Surgical Wound Healing

Not Applicable

Completed

• Conditions: Wound Healing; Surgery; Stress
• Interventions: Behavioral: Stress reduction intervention

• Registration Number: NCT00633737
• Lead Sponsor: University of Auckland, New Zealand

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-04
• Study First Posted: 2008-03-12
• Primary Completion: 2010-05
• Study Completion: 2010-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-19
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Stress reduction intervention	Stress reduction intervention

Primary Outcome Measures

Name	Time	Method
expanded polytetrafluoroethylene (ePTFE) tubes assessed for hydroxyproline deposited per unit length of the tube as well as total protein	7 days following surgery

Secondary Outcome Measures

Name	Time	Method
Plasma catecholamines	morning of surgery, day after surgery, 7 days after surgery
Salivary cortisol	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	7 days after surgery
self-rated recovery (including fatigue, pain)	7 days post-surgery

Trial Locations

Locations (1)

The University of Auckland; 🇳🇿 Auckland, New Zealand