Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000971639
Ethics application status
Approved
Date submitted
3/09/2014
Date registered
10/09/2014
Date last updated
10/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Emotional writing and wound healing
Scientific title
Emotional disclosure writing in healthy university students and how it effects wound healing
Secondary ID [1] 285279 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound healing 292941 0
Condition category
Condition code
Inflammatory and Immune System 293238 293238 0 0
Normal development and function of the immune system
Mental Health 293269 293269 0 0
Studies of normal psychology, cognitive function and behaviour
Skin 293270 293270 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Emotional disclosure writing
Participants who complete the intervention will be asked on 3 consecutive days. On each day they will write for 20 minutes about a traumatic or upsetting experience in their life. They will be instructed to delve (dig deep) into their deepest emotions and thoughts. This will be administered online. Participants will be sent a secure link each day to compete in their own time. The task will not be supervised. The writing will be stored on the researchers computer under the participants ID code and will only be shared with the study supervisors. Participants will receive a 4mm punch biopsy wound either 14 days after the first writing session or will start the task the day after the 4mm punch biopsy (in order to see whether the timing of the intervention matters). The biopsy will be performed by a registered dermatologist at the clinical research center in campus. To perform the biopsy, the skin on the upper arm will be marked and cleaned, then anaesthetised. A punch biopsy will be performed and the skin samples will be stored and transported to the lab for analysis.
Intervention code [1] 290169 0
Other interventions
Comparator / control treatment
Time management writing
Participants who complete the intervention will be asked on 3 consecutive days. On each day they will write for 20 minutes about how they spend their time. They will be instructed to be as objective and descriptive as possible (i.e. just the facts, no emotions, no opinions, no feelings). They will be asked to concentrate on the specific details of their activities, even when referring to everyday tasks. On the first day they will write about the past 7 days, on the second day they will write about the past 24 hours and the third day they will write about their plans for the next 7 days. Participants will be sent a secure link each day to compete in their own time. The task will not be supervised. The writing will be stored on the researchers computer under the participants ID code and will only be shared with the study supervisors. Participants will receive a 4mm punch biopsy wound either 14 days after the first writing session or will start the task the day after the 4mm punch biopsy (in order to see whether the timing of the intervention matters). The biopsy will be performed by a registered dermatologist at the clinical research center in campus. To perform the biopsy, the skin on the upper arm will be marked and cleaned, then anaesthetised. A punch biopsy will be performed and the skin samples will be stored and transported to the lab for analysis.
Control group
Active

Outcomes
Primary outcome [1] 293088 0
Speed of healing of a 4mm biopsy wound as indicated by photographs and immunological and histological analyses. The 1st biopsy will be embedded in paraffin and immunohistology will be performed to identify CD1a, HLA-DR, CD-68.
The 2nd biopsy will be 5mm and will be taken 14 days after the initial biopsy at the same site. This biopsy will be split into two – half with be snap frozen and half will be embedded in paraffin.
The snap frozen will be analyzed for
1. Cytokines – IL1, IL6, TNFalpha
2. Collagen – type I/III collagens, glycosaminoglycans and collagen crosslinking, PICP (collagen synthesis), MMP9 (inflammation) MMP2 (collagen remodelling)
The section embedded in paraffin will be analyzed for immunohistology (CD1a to identify Langarhan cells; HLA-DR for immune cell activation; CD-68 to identify macrophages)
Timepoint [1] 293088 0
14 days after the 4mm initial biopsy a 5mm biopsy will be taken at the same site
Secondary outcome [1] 310313 0
Mood-Affect Valuation Index; AVI
Timepoint [1] 310313 0
14 days after the initial biopsy
Secondary outcome [2] 310380 0
Mood- Life Orientation Test; LOT
Timepoint [2] 310380 0
14 days after initial biopsy
Secondary outcome [3] 310381 0
Perceived Stress-Perceived Stress Scale
Timepoint [3] 310381 0
14 days after the initial biopsy
Secondary outcome [4] 310382 0
Social support- Medical Outcomes Study: Social Support Survey Instrument
Timepoint [4] 310382 0
14 days after the initial biopsy
Secondary outcome [5] 310383 0
Depression -General Health Questionnaire
Timepoint [5] 310383 0
14 days after the initial biopsy
Secondary outcome [6] 310384 0
Sleep- Pittsburgh Sleep Quality Index
Timepoint [6] 310384 0
14 days after the initial biopsy

Eligibility
Key inclusion criteria
Aged between 18 and 55, able to read and write in English, non smoker
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria will include people with current inflammatory skin disease and chronic illness and people with immunological-related health problems or people taking medication that affect immune functioning. Additionally participants allergic to lignocaine (or any other local anaesthetic) will be excluded because this will be used to locally anaesthetize the tissue before performing the punch biopsy procedure.

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)
Participants will be recruited from the University of Auckland through an advertisement flyer promoted through social media, the University of Auckland’s junk email address book, in public areas at the university’s campuses, from emails sent by course coordinators to the university’s students, and student notice boards throughout the Auckland University campus’.
Interested participants will be screened for eligibility using inclusion/exclusion criteria. Upon verbally consenting the researcher will look at a randomized list created through random.org to allocate the participant to one of four groups. The researcher would ask a colleague to put the participants code on a sealed envelope and the group allocation inside. When the researcher contacts them and determines they are eligible she will open the envelope to reveal the group.
Participants will then be sent a link to go online and complete consent and a baseline questionnaire. Depending on whether they receive the intervention before or after the initial biopsy they will also be given the control or intervention instructions for the writing task.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomized list will be generated used the website random.org. This will allocate participants to one of four conditions: emotional writing before initial biopsy, control writing before initial biopsy, emotional writing after initial biopsy or control writing after initial biopsy
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power calculation based on Koshwanez et al. (2013) was conducted using a medium effect size. With power set at .80 and a two tailed significant level of a = .05; the total sample size required for an ANCOVA analysis with 4 groups was calculated to be 128 (32 per group). 140 participants will be recruited in total (35 per group) to allow for attrition.
Analysis will be conducted on immunological and histological outcomes using an ANOVA

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment outside Australia
Country [1] 6334 0
New Zealand
State/province [1] 6334 0
Auckland

Funding & Sponsors
Funding source category [1] 289903 0
University
Name [1] 289903 0
The University of Auckland
Country [1] 289903 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 288592 0
None
Name [1] 288592 0
Address [1] 288592 0
Country [1] 288592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291624 0
The University of Auckland Human Ethics Committee
Ethics committee address [1] 291624 0
Ethics committee country [1] 291624 0
New Zealand
Date submitted for ethics approval [1] 291624 0
29/07/2014
Approval date [1] 291624 0
16/08/2014
Ethics approval number [1] 291624 0
012656

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

Contacts
Principal investigator
Name 51186 0
Dr Elizabeth Broadbent
Address 51186 0
AUCKLAND HOSPITAL
Level 1, Room 599-12003
PARK RD
Auckland 1023
GRAFTON
New Zealand
Country 51186 0
New Zealand
Phone 51186 0
+64 (0) 9 923 6756
Fax 51186 0
Email 51186 0
[email protected]
Contact person for public queries
Name 51187 0
Elizabeth Broadbent
Address 51187 0
AUCKLAND HOSPITAL
Level 1, Room 599-12003
PARK RD
Auckland 1023
GRAFTON
New Zealand
Country 51187 0
New Zealand
Phone 51187 0
+64 (0) 9 923 6756
Fax 51187 0
Email 51187 0
[email protected]
Contact person for scientific queries
Name 51188 0
Elizabeth Broadbent
Address 51188 0
AUCKLAND HOSPITAL
Level 1, Room 599-12003
PARK RD
Auckland 1023
GRAFTON
New Zealand
Country 51188 0
New Zealand
Phone 51188 0
+64 (0) 9 923 6756
Fax 51188 0
Email 51188 0
[email protected]

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
No additional documents have been identified.