To establish a causal link between psychosocial resilience factors and wound healing and to elucidate potential underlying pathways.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
n.v.t.: Onderzoek vindt plaats met gezonde mentaal capabele en wilsbekwame participanten.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes:
Wound surface is determined by digital imaging of the wound 3 - 8 days post
wound-induction;
Reepithalisation is measured by comparing trans-epidermal water loss above the
wound with taht above non damaged skin at 3-8 days .
Secondary outcome
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 (AUC) and cortisol awakening response;
Optimism and positive affect.
Background 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 of mindfulness/resilience on
woundhealing.
Study objective
To establish a causal link between psychosocial resilience factors and wound
healing and to elucidate potential underlying pathways.
Study design
Experimental between subjects design (single blind, randomized) with 2
conditions (waiting list control vs. mindfulness).
Intervention
Psychological intervention: The experimental group receives a standardized 8
week mindfulness intervention adopting the mindfulness based cognitive therapy
(MBCT) protocol. The control group enters a waiting list.
Wound induction: 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 * 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.
Study burden and risks
The risks of the blister-suction protocol are very minor. Although no skin
deformation or scarring has been reported minor skin discoloration may occur in
dark-skinned people. Since wounds are created in the epidermis there*s a
potential risk of infection. This risk is kept at an minimum by using
sterilized materials and covering the wound sites.
Universiteitssingel 40
Maastricht 6200MD
NL
Universiteitssingel 40
Maastricht 6200MD
NL
Listed location countries
Age
Inclusion criteria
- Age between 18 and 40 years old
- Only participants who voluntarily signed up to follow a mindfulness training
Exclusion criteria
- 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)
-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)
- 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
- Psychopathological conditions / psychological treatment currently or over the past 6 months / previous psychiatric hospitalization (all self report)
- Structural meditation practice (including yoga, tai chi, etc.)
- Allergic responses to adhesives, bandages, or tapes, needle or blood phobias
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Nederlands Trial Register nummer 13414 |
| CCMO | NL37182.068.12 |