Mindfulness and Wound healing.|
|- candidate number||13414|
|- NTR Number||NTR3652|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-okt-2012|
|- Secondary IDs||37182 CCMO|
|- Public Title||Mindfulness and Wound healing.|
|- Scientific Title||The effects of a mindfulness intervention on wound healing.|
|- hypothesis||Mindfulness improves wound healing|
|- Healt Condition(s) or Problem(s) studied||Healing process, Wound|
|- Inclusion criteria||1. Age between 18 and 40 years old;|
2. Only participants who voluntarily signed up to follow a mindfulness training.
|- Exclusion criteria||1. Self-reported health problems use that could influence cortisol levels, immune functioning and/or wound healing (e.g. auto-immune diseases, cancer, recent surgery, strokes, diabetes mellitus, peripheral vascular disease);|
2. Self-reported medication use that could influence cortisol levels, immune functioning and/or wound healing (e.g. anti-diuretics, blood pressure regulators, psychotropic medication, anti-inflammatory drugs);
3. Other factors that may impact on cortisol levels, immune functioning and/or wound healing: self reported recreational drug use, heavy alcohol use (i.e. more than 10 alcoholic beverages per week for women and more than 20 for men), more than 10 units of caffeinated drinks per day;
4. Psychopathological conditions / psychological treatment currently or over the past 6 months / previous psychiatric hospitalization (all self report);
5. Structural meditation practice (including yoga, tai chi, etc.);
6. Allergic responses to adhesives, bandages, or tapes, needle or blood phobias.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2012|
|- planned closingdate||1-apr-2013|
|- Target number of participants||66|
|- Interventions||In this study we're investigating the effects of an 8-week mindfulness intervention (protocollized according to Mindfulness Based Cognitive Therapy) on wound healing. The primary outcome variable of our study is wound healing which will be qunatified by measuring the wound surface area and trans epidermal water loss. As potential mediating factors (and thus potential pathways) we measure citokines that are released during the anflammatory stage in the wound fluid, and cortisol levels in saliva. In order to evaluate the effects of mindfulness on these factors, we compare these effects against a waiting list control group, meaning a group participants who are interested in mindfulness but who are placed on a waiting list and as a result do not participate in any intervention during 8 weeks.
As mentioned before, the mindfulness intervention comprises 8 weeks of weekly group meetings lasting between 2 to 2,5 hours and the participants will be encouraged to practice mindfulness exercises at home on a daily basis for 30 to 60 minutes.
|- Primary outcome||Wound healing:|
1. Wound surface area;
2. Trans epidermal water loss.
|- Secondary outcome||1. Psychological data (mindfulness, optimism, mood, stress);|
2. Salivary cortisol;
3. Cytokines in wound exudate.
|- Timepoints||Psychological assessments & salivary cortisol pre- and post-intervantion / waiting period.|
Wound assessment post-intervention / waiting period during 9 days.
|- Trial web site||toetsingonline.ccmo.nl|
|- CONTACT FOR PUBLIC QUERIES|| Yvo Meevissen|
|- CONTACT for SCIENTIFIC QUERIES|| Yvo Meevissen|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|- Brief summary||The process of wound healing has been demonstrated to be related to psychosocial factors. Most of these studies focused on vulnerability factors impairing the wound healing process whereas psychological resilience factors (e.g. optimism, positive affect) have hardly been studied. Two studies provide preliminary evidence for the role of psychological resilience in wound healing. However, these were correlational studies and potential underlying mechanisms were not examined. |
The present study attempts to establish a causal link between psychosocial resilience factors and wound healing by using an intervention to increase resilience. For this purpose mindfulness training is used because this intervention has previously been shown to be able to increases psychological resources like positive emotions and optimism. Moreover, mindfulness is able to affect immune functioning and cortisol responsivity, the proposed key mediators of the association between psychological resources and wound healing.
We hypothesize (1) that a mindfulness intervention compared to a waiting list control condition is related to increased psychological resilience and thereby to faster wound healing (i.e. wound surface area and trans-epidermal water loss); (2) that decreased cortisol levels and increased production of pro-inflammatory cytokines in wound fluid mediate the effects of mindfulness/resilience on wound healing.
The experimental group receives a 8 week mindfulness intervention, following a standardized protocol, and delivered by trained mindfulness trainers. The control group enters a waiting list.
Eight small 8mm diameter wounds are created on the forearm by a safe and standardized blister-suction procedure performed by a medically trained assistant. 350 mmHg suction is applied through the holes of a template during 1 to 1 ½ hour creating 8 small blisters. After removal of the epidermis another sterile template with 8 wells containing a standardized isotone 0,9% NaCl in albumin solution covers the wounds to allow for exudate extraction. The well template is detached the next day, and the wound site is covered sterile.
Wound surface is determined by digital imaging of the wound 3 – 8 days post wound-induction; Re-epithelialization is measured by comparing trans-epidermal water loss above the wound with non-damaged skin at 3-8 days.
Secondary outcomes/mediators: Cytokines (IL-1α, IL-1β IL6, IL8, TNF-β) from wound exudate 3, 6, and 22 hours post wound-induction; Daily cortisol levels and cortisol awakening response; Optimism and positive affect.
Participants are screened for in- and exclusion variables and randomized in one of two conditions. Before and after the 8 week intervention/waiting period, psychological questionnaires are administered and on 3 consecutive days cortisol samples are taken (4/day). After the intervention/waiting period participants are individually invited to the lab from 7 am to 4 pm for wound induction and the 3 and 6 hours extraction of wound fluid. They return the next day for another wound fluid extraction (22 hours).At 3-8 days post wound-induction wound surface and trans-epidermal water loss is determined.
|- Main changes (audit trail)|
|- RECORD||6-okt-2012 - 7-nov-2012|
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