None listed
Conditions
Brief summary
There is currently a shortage of kidneys for donation in New Zealand. Any measures that can improve the process of patients giving live donation of kidneys will help meet this shortage. Kidney donor patients pre-operatively are fit and well. Studies have shown that a laparoscopic (keyhole) approach to nephrectomy aids in a quick recovery. Despite this, in the follow up of these patients it appears that fatigue may persist post surgery. This may be due to sleep disturbance from the operation, anaesthetic and hospital stay. Surgery and anaesthesia are known to cause sleep disturbances and fatigue, in part due to a disturbance in the circadian clock which controls sleep. In a pilot study we are currently completing at Wellington hospital (approved by the central ethics committee) we have already shown that sleep and circadian rhythms are disrupted in kidney donor patients. In the current study we will extend these findings further with a protocol with higher resolution than used in the pilot. In addition we will also investigate the efficacy of light in treating this sleep and circadian disruption. We will recruit 40 patients scheduled to undergo laparoscopic donor nephrectomy surgery at Auckland City Hospital, and will monitor sleep and activity (using actiwatches), circadian rhythms (using urine samples) and fatigue and mood (using questionnaires) for three days prior to and three days after their surgery. Half of these patients will receive 180 minutes of light administration during surgery and half will receive placebo light administration. Data from these patients will provide a clear understanding of the extent of sleep disruption and mood reduction which is attributable to hospitalization and surgery, and importantly the efficacy of light therapy in treating/preventing this disruption.
Interventions
The intervention consists of administration of bright light (max. 10, 000 lux) for up 180 minutes during surgery. Light is delivered to the patient via a specifically designed human light mask.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Patients must: a)be scheduled for elective laproscopic nephrectomy surgery at Auckland City Hospital b) be over 18 years of age. c) provide written informed consent.
Exclusion criteria
Patients will be excluded if: a) they do not meet the inclusion criteria. b) they are already enrolled in another concurrent clinical trial. c) A documented sleep condition which they have current active treatment for. d) At the principal investigator’s discretion.
Outcome results
None listed