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1.  Hardiness and Outcome of Self-catheterisation Training (HOST): protocol for an observational study exploring the effects of personality traits in women on ability to learn clean intermittent self-catheterisation 
BMJ Open  2014;4(1):e003986.
Introduction
Clean intermittent self-catheterisation (CISC) is the recommended first-line management of voiding dysfunction; however, psychological factors involved in acceptance and take up are often neglected. There is a tendency to discuss the success of CISC in relation to factors that affect teaching and learning, with subsequent success or failure being attributed to these. There is limited research investigating what extent, personality traits impact on a woman's willingness to learn CISC and subsequent mastery of the technique.
Method and analysis
All women attending a tertiary urogynaecology department as eligible for CISC will be invited to participate in the study. Over the 14-month recruitment period, an estimated 130 women will be involved. The participants will complete a series of self-reported questionnaires. Personality types will be assessed using The Hardiness Scale and State-Trait Anxiety Inventory. The impact of urinary symptoms and CISC on quality of life (QoL) will be measured using an electronic pelvic-floor assessment questionnaire (ePAQ). Success and mastery will be measured by recording the number of hospital appointments and the length of time taken to learn. Confidence will be measured using the Likert scale. A sample of 20 women will be invited to participate in semi-structured in-depth interviews to explore women's views and experiences of CISC.
Ethics and dissemination
Regulatory approvals will be in place prior to the start of the study. Good clinical practice guidelines will be followed throughout. Eligibility and training for CISC will be undertaken in accordance to individualised care plans in line with unit protocol and will not be influenced by the study. Trial data will be anonymised and participant confidentiality will be maintained. The Study findings will be disseminated through publications in relevant journals and will be presented at multiprofessional conferences and scientific meetings.
doi:10.1136/bmjopen-2013-003986
PMCID: PMC3902464  PMID: 24401725
2.  The effect of MELatOnin on Depression, anxietY, cognitive function and sleep disturbances in patients with breast cancer. The MELODY trial: protocol for a randomised, placebo-controlled, double-blinded trial 
BMJ Open  2012;2(1):e000647.
Introduction
Breast cancer represents about one-third of all cancer diagnoses and accounts for about 15% of cancer deaths in women. Many of these patients experience depression, anxiety, sleep disturbances and cognitive dysfunction. This may adversely affect quality of life and also contribute to morbidity and mortality. Melatonin is a regulatory circadian hormone having, among others, a hypnotic and an antidepressive effect. It has very low toxicity and very few adverse effects compared with the more commonly used antidepressants and hypnotics.
Methods and analysis
The objective of this double-blind, randomised, placebo-controlled trial is to investigate whether treatment with oral melatonin has a prophylactic or ameliorating effect on depressive symptoms, anxiety, sleep disturbances and cognitive dysfunction in women with breast cancer. Furthermore, the authors will examine whether a specific clock-gene, PER3, is correlated with an increased risk of depressive symptoms, sleep disturbances or cognitive dysfunction. The MELODY trial is a prospective double-blinded, randomised, placebo-controlled trial in which the authors intend to include 260 patients. The primary outcome is depressive symptoms measured by the Major Depression Inventory. The secondary outcomes are anxiety measured by a Visual Analogue Scale, total sleep time, sleep efficiency, sleep latency and periods awake measured by actigraphy and changes in cognitive function measured by a neuropsychological test battery. Tertiary outcomes are fatigue, pain, well-being and sleep quality/quantity measured by Visual Analogue Scale and sleep diary and sleepiness measured by the Karolinska Sleepiness Scale. The PER3 genotype is also to be determined in blood samples.
Article summary
This is a protocol article on the MELODY trial. The objective of this double-blind randomized, placebo-controlled trial is to investigate whether daily treatment with 6 mg oral melatonin has a prophylactic or ameliorating effect on depressive symptoms, anxiety, sleep disturbances and cognitive dysfunction in women with breast cancer. Furthermore to examine whether a specific clock-gene PER3 is correlated with an increased risk of depressive symptoms, sleep disturbances or cognitive dysfunction.
doi:10.1136/bmjopen-2011-000647
PMCID: PMC3278491  PMID: 22240653

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