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Trial registered on ANZCTR


Registration number
ACTRN12613000281796
Ethics application status
Approved
Date submitted
7/03/2013
Date registered
8/03/2013
Date last updated
11/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Does written emotional disclosure improve wound healing in surgical patients?
Scientific title
Single-blinded randomized controlled trial with bariatric surgery patients investigating the effects of an written emotional disclosure intervention on surgical wound healing
Secondary ID [1] 281774 0
none
Universal Trial Number (UTN)
U1111-1138-7122
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
healing of surgical wounds 288138 0
Condition category
Condition code
Surgery 288509 288509 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will be asked to write for 20 minutes a day, for three days about upsetting/traumatic events in their lives (written emotional disclosure). This writing will take place approximately 2 weeks prior to surgery. This writing will be completed in a quiet place at the patient's home.

At the baseline visit (after written informed consent has been obtained), the Study Co-ordinator will give the participant an envelope containing writing instructions (that have been randomized). Along with the writing instructions, the envelope will contain a notebook, a pen, a post-writing questionnaire, and a pre-paid envelope to post completed essays back to investigators (at the participant’s discretion). Note: the writing can be performed by typing or by hand (in the notebook provided).

The writing will not be supervised, as the writing will be performed at the participant's home, at a time convenient to the participant. However, the participant will be contacted by the Study Co-ordinator on the first day of writing to remind the participant to write, and to provide the participant the opportunity to ask any questions they may have.
Intervention code [1] 286350 0
Other interventions
Comparator / control treatment
Participants in the control group will be asked to write for 20 minutes a day, for three days, about how they spend their time (time management). This writing will take place approximately 2 weeks prior to surgery. This writing will be completed in a quiet place at the patient's home.
Control group
Active

Outcomes
Primary outcome [1] 288757 0
Hydroxyproline yield in ePTFE tubes implanted at the wound site (laparoscopic ports)

Briefly, at the end of the surgical procedure, prior to wound closure, two sterile ePTFE tubes with an internal diameter of 1.2mm and a 0.6mm wall thickness, internodal distance (pore size) of 90-120um, and length of approximately 6cm, will be inserted into two laparoscopic ports (in adipose tissue). The end of the ePTFE tubes will be trimmed and sutured to the skin to avoid accidental removal. A standard sterile dressing will be applied. (The material deposited in the tube over the course of healing will be assessed for hydroxyproline deposited per unit length of the tube). ePTFE tube implantation will be performed by the surgeon, with guidance from the Study Co-ordinator and/or Research Nurse.

At 14 days post-surgery (during the patient's scheduled follow-up visit with the surgeon), the ePTFE tubes will be removed under local anesthesia. The tubes will be stored at the University of Auckland at -80C until processing.

Hydroxyproline yield will be determined as per published protocol (Broadbent et al., 2012). Briefly, the ePTFE tubes will be cut to a length of 5cm and submerged in HCl to breakdown the protein into composite amino acids. The samples will then be freeze dried for 24 hours. Once dry, the samples will be mixed with a series of solutions (i.e. water, NaOH, isopropyl alcohol, acetate-citrate buffer, Erlich’s reagent), vortexed, incubated, and then analyzed using a spectrophotometer (absorbance at 558nm). Hydroxyproline concentrations will be determined by comparing to a standard curve for hydroxyproline.
Timepoint [1] 288757 0
14 days post surgery
Secondary outcome [1] 300910 0
between group differences in stress-induced immune cell redistribution profiles.
Timepoint [1] 300910 0
blood samples from baseline, at anaesthesia induction, and at 30 minutes post surgery will be obtained to investigate leukocyte (monocytes, lymphocytes, neutrophils) moblization (ie. temporary increase in cell numbers from baseline), trafficking (temporary decrease in cell numbers from baseline), and redistribution profiles (mean value of moblization and trafficking scores) as per previously published formulaes.
Secondary outcome [2] 300911 0
between group differences in pro- and anti-inflammatory cytokines and cortisol (between-group differences). These cytokines and cortisol will be assayed from the wound fluid collected in the mini-vac device inserted into one of the laparoscopic ports.
Timepoint [2] 300911 0
24 hours post surgery
Secondary outcome [3] 300912 0
between group difference in sleep (hours of minimal motion) while in hospital, as measured by actiwatches.
Timepoint [3] 300912 0
average hours of minimal motion over the days while in hospital.
Secondary outcome [4] 300913 0
between group differences in the change of perceived stress scores, mood, fatigue, health-related behaviours (i.e. sleep, food intake, exercise, alcohol consumption) and symptom reporting (from baseline to 14, and 30 days post-surgery). This will be measured using self-report questionnaires
Timepoint [4] 300913 0
14 days, and 30 days post surgery
Secondary outcome [5] 300914 0
Between group differences in 'return back to work date'.

This will be assessed using a self-report question contained in the 30-Day Post-Surgery Questionnaire booklet that will be mailed to each participant.
Timepoint [5] 300914 0
30 days post surgery
Secondary outcome [6] 300915 0
Between group differences in the percentage of positive, negative, insightful, cognitive words, and total pronouns used in essays.

To assess this, the essays will be transcribed into electronic format. These files will be processed using the Linguistic Inquiry and Word Counts (LIWC) software package. The LIWC program will calculate the percentage of positive, negative, causal/insightful words and total pronouns included in each essay.
Timepoint [6] 300915 0
Averaged over the 3 days of writing (pre-surgery)
Secondary outcome [7] 300916 0
Between group differences in how emotional writing was rated. Emotional ratings will be obtained from the post-writing questionnaire supplied with the writing instructions, to be filled out by the patient after each 20 minute writing session.
Timepoint [7] 300916 0
averaged over the 3 days of writing (pre-surgery)

Eligibility
Key inclusion criteria
all patients who are scheduled for bariatric surgery at ADHB
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
aged less than 16 years; unable to communicate in English; have enduring power of attorney (e.g. may lack the ability to consent freely); and, are currently clinically depressed

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)
The clinic specialist nurse and/or surgeons will inform eligible patients of the study while at their specialist GI clinic appointment.

The study co-ordinator will meet with interested eligible patients after their clinic appointment to answer questions and to go over the Participant Information Sheet and Consent Form (Patient has up to 3 days to provide informed consent).

The patient can take up to three days to give informed consent. This allows the patient time to discuss their participation in the study with their family/loved ones. The Study Co-ordinator will arrange to meet the patient (either at the University or at Auckland City Hospital/Greenlane) if the patient does not consent the same day as their clinic appointment.

Once written informed consent is obtained, the participant will be randomly allocated to one of two writing groups. The study co-ordinator will be blinded to group allocation. Participants will be given an opaque envelope containing the writing instructions for the group they have been assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed by a computer-generated random list and concealed in consecutively numbered opaque envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS will be used to analyse the data. The primary analysis will be an independent t-test to test the hypothesis that the intervention group will have higher hydroxyproline than the control group. Independent t-tests will also be performed to test differences in symptom reports and fatigue at follow-up. To test immune pathways involved, we will assess whether patients who receive the emotional disclosure intervention show a more adaptive circulating leukocyte redistribution, and an altered balance of pro-inflammatory and anti-inflammatory cytokines in wound fluid. ANCOVA on change scores controlling for baseline will be conducted to compare groups with respect to changes in stress and mood following the intervention. Regression analyses will be conducted to assess whether stress reduction or increases in positive mood mediate the effects of the intervention on wound healing. We will also assess the effects of the intervention on sleep and health behaviours as potential mechanisms.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/03/2013
Actual
17/05/2013
Date of last participant enrolment
Anticipated
Actual
30/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
54
Recruitment outside Australia
Country [1] 4830 0
New Zealand
State/province [1] 4830 0
Auckland

Funding & Sponsors
Funding source category [1] 286655 0
Charities/Societies/Foundations
Name [1] 286655 0
Auckland Medical Research Foundation
Country [1] 286655 0
New Zealand
Primary sponsor type
Individual
Name
Elizabeth Broadbent
Address
Dept of Psychological Medicine
FMHS
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland
1142
Country
New Zealand
Secondary sponsor category [1] 285434 0
None
Name [1] 285434 0
Address [1] 285434 0
Country [1] 285434 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288727 0
Health and Disability Ethics Committee
Ethics committee address [1] 288727 0
Ethics committee country [1] 288727 0
New Zealand
Date submitted for ethics approval [1] 288727 0
31/01/2013
Approval date [1] 288727 0
12/02/2013
Ethics approval number [1] 288727 0
13/NTB/17

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37046 0
Dr Elizabeth Broadbent
Address 37046 0
Dept Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland, New Zealand
1142
Country 37046 0
New Zealand
Phone 37046 0
+ 64 09 373 7599 ext 86756
Fax 37046 0
Email 37046 0
e.broadbent@auckland.ac.nz
Contact person for public queries
Name 37047 0
Elizabeth Broadbent
Address 37047 0
Dept Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland, New Zealand
1142
Country 37047 0
New Zealand
Phone 37047 0
+ 64 09 373 7599 ext 86756
Fax 37047 0
Email 37047 0
e.broadbent@auckland.ac.nz
Contact person for scientific queries
Name 37048 0
Elizabeth Broadbent and/or Heidi Koschwanez
Address 37048 0
Dept Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland, New Zealand
1142
Country 37048 0
New Zealand
Phone 37048 0
+ 64 09 373 7599 ext 86756
Fax 37048 0
Email 37048 0
e.broadbent@auckland.ac.nz AND/OR h.koschwanez@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomized clinical trial of expressive writing on wound healing following bariatric surgery.2017https://dx.doi.org/10.1037/hea0000494
N.B. These documents automatically identified may not have been verified by the study sponsor.