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Completed

NCT Number: NCT00633737

The Effects of Stress Reduction on Surgical Wound Healing

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Auckland

Auckland, 1001, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Stress reduction intervention

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Collaborators

  • Health Research Council, New Zealand

Registry information

Official study title

The Effects of Stress Reduction on Surgical Wound Healing: A Randomised Controlled Trial

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 12, 2008
Registry last updated
Dec 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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