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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?
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Scientific title
Single-blinded randomized controlled trial with bariatric surgery patients investigating the effects of an written emotional disclosure intervention on surgical wound healing
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Secondary ID [1]
281774
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none
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Universal Trial Number (UTN)
U1111-1138-7122
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
healing of surgical wounds
288138
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Condition category
Condition code
Surgery
288509
288509
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
286350
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Other interventions
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
288757
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Timepoint [1]
288757
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14 days post surgery
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Secondary outcome [1]
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between group differences in stress-induced immune cell redistribution profiles.
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Assessment method [1]
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Timepoint [1]
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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.
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Secondary outcome [2]
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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.
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Assessment method [2]
300911
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Timepoint [2]
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24 hours post surgery
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Secondary outcome [3]
300912
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between group difference in sleep (hours of minimal motion) while in hospital, as measured by actiwatches.
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Assessment method [3]
300912
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Timepoint [3]
300912
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average hours of minimal motion over the days while in hospital.
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Secondary outcome [4]
300913
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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
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Assessment method [4]
300913
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Timepoint [4]
300913
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14 days, and 30 days post surgery
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Secondary outcome [5]
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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.
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Assessment method [5]
300914
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Timepoint [5]
300914
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30 days post surgery
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Secondary outcome [6]
300915
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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.
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Assessment method [6]
300915
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Timepoint [6]
300915
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Averaged over the 3 days of writing (pre-surgery)
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Secondary outcome [7]
300916
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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.
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Assessment method [7]
300916
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Timepoint [7]
300916
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averaged over the 3 days of writing (pre-surgery)
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Eligibility
Key inclusion criteria
all patients who are scheduled for bariatric surgery at ADHB
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
28/03/2013
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Actual
17/05/2013
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Date of last participant enrolment
Anticipated
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Actual
30/03/2015
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
90
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Accrual to date
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Final
54
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Recruitment outside Australia
Country [1]
4830
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New Zealand
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State/province [1]
4830
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Auckland
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Funding & Sponsors
Funding source category [1]
286655
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Charities/Societies/Foundations
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Name [1]
286655
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Auckland Medical Research Foundation
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Address [1]
286655
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PO Box 110139
Auckland Hospital
Auckland 1148
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Country [1]
286655
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New Zealand
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Primary sponsor type
Individual
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Name
Elizabeth Broadbent
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Address
Dept of Psychological Medicine
FMHS
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland
1142
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Country
New Zealand
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Secondary sponsor category [1]
285434
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None
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Name [1]
285434
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Address [1]
285434
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Country [1]
285434
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288727
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Health and Disability Ethics Committee
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Ethics committee address [1]
288727
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Ministry of Health
PO Box 5013
Wellington 6145
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Ethics committee country [1]
288727
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New Zealand
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Date submitted for ethics approval [1]
288727
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31/01/2013
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Approval date [1]
288727
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12/02/2013
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Ethics approval number [1]
288727
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13/NTB/17
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Summary
Brief summary
Surgery is a psychological stressor, with patients’ concerns including fear of pain, death, and separation from family. Psychological stress has been shown to impair the production of cytokines involved in wound healing and to slow the healing of small experimental wounds. Psychological stress has also been associated with altered levels of pro- and anti-inflammatory cytokines and metalloproteinases involved in wound repair in surgical patients. Furthermore, relaxation exercises have been found to improve indices of wound healing and levels of fatigue following surgery. More research is needed to investigate the effects of other types of interventions on healing after surgery. There is evidence that three, 20-minute sessions of writing about personal emotional events can improve the healing of small experimental wounds, but no research has investigated the effects of expressive writing on the healing of wounds in surgical patients. This research aims to test whether written emotional disclosure can improve wound healing in surgical patients. We will randomise 90 patients scheduled to undergo bariatric surgery to either write about traumatic events or to a control group. We will measure stress, mood, social support, cytokines, fatigue, and wound healing. This research has implications for the delivery of pre-operative care to optimise outcomes
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Trial website
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Trial related presentations / publications
In process of analyzing data - study closed, but not complete
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Public notes
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Contacts
Principal investigator
Name
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Dr Elizabeth Broadbent
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Address
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Dept Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland, New Zealand
1142
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Country
37046
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New Zealand
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Phone
37046
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+ 64 09 373 7599 ext 86756
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Fax
37046
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Email
37046
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[email protected]
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Contact person for public queries
Name
37047
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Dr Elizabeth Broadbent
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Address
37047
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Dept Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland, New Zealand
1142
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Country
37047
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New Zealand
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Phone
37047
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+ 64 09 373 7599 ext 86756
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Fax
37047
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Email
37047
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[email protected]
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Contact person for scientific queries
Name
37048
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Dr Elizabeth Broadbent and/or Heidi Koschwanez
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Address
37048
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Dept Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland, New Zealand
1142
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Country
37048
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New Zealand
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Phone
37048
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+ 64 09 373 7599 ext 86756
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Fax
37048
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Email
37048
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[email protected]
AND/OR
[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Randomized clinical trial of expressive writing on wound healing following bariatric surgery.
2017
https://dx.doi.org/10.1037/hea0000494
N.B. These documents automatically identified may not have been verified by the study sponsor.
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