Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00633737




Registration number
NCT00633737
Ethics application status
Date submitted
4/03/2008
Date registered
12/03/2008
Date last updated
23/12/2013

Titles & IDs
Public title
The Effects of Stress Reduction on Surgical Wound Healing
Scientific title
The Effects of Stress Reduction on Surgical Wound Healing: A Randomised Controlled Trial
Secondary ID [1] 0 0
Wound healing study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound Healing 0 0
Stress 0 0
Surgery 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Stress reduction intervention

Experimental: 1 - Stress reduction intervention

No intervention: 2 - Standard care


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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
expanded polytetrafluoroethylene (ePTFE) tubes assessed for hydroxyproline deposited per unit length of the tube as well as total protein
Timepoint [1] 0 0
7 days following surgery
Secondary outcome [1] 0 0
Plasma catecholamines
Timepoint [1] 0 0
morning of surgery, day after surgery, 7 days after surgery
Secondary outcome [2] 0 0
Salivary cortisol
Timepoint [2] 0 0
on morning before surgery (one sample). on day after surgery: samples immediately after waking, after 15 minutes, after 30 minutes and after 60 minutes
Secondary outcome [3] 0 0
wound infection
Timepoint [3] 0 0
7 days after surgery
Secondary outcome [4] 0 0
self-rated recovery (including fatigue, pain)
Timepoint [4] 0 0
7 days post-surgery

Eligibility
Key inclusion criteria
* planned elective laparoscopic cholecystectomy at Manukau Surgical Centre
* able to understand English
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Health Research Council, New Zealand
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00633737
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Elizabeth A Broadbent, PhD
Address 0 0
The University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00633737