title: Effect of Melatonin on Sleep in the Perioperative Period after Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.
abstract: OBJECTIVE
  To investigate whether administration of an oral dose of 6 mg melatonin before bedtime perioperatively in breast cancer surgery could change sleep outcomes measured by actigraphy.
  
  
  METHODS
  This paper reports secondary outcomes from a double-blind, placebo-controlled, randomized clinical trial where patients received 6 mg melatonin (n = 27) or placebo (n = 21) approximately 60 minutes before bedtime 3 nights preoperatively until at least one week postoperatively. Participants were monitored in the entire period with actigraphy, and were instructed to complete visual analogue scale (VAS) for sleep, and the Karolinska Sleepiness Scale (KSS) each morning.
  
  
  RESULTS
  Administration of 6 mg oral melatonin approximately 1 hour before bedtime resulted in significantly increased sleep efficiency and reduced wake after sleep onset for the entire 2-week postoperative period. No other significant differences for actigraphy determined sleep outcomes or subjective outcome parameters in the perioperative period were found between the groups. Overall, the patients sleep outcomes were within normal ranges and no participants had pathological sleep disturbances.
  
  
  CONCLUSIONS
  Melatonin significantly changed sleep efficiency and wake after sleep onset after surgery, but had no effects on other objective sleep outcomes or on subjective sleep quality (VAS and KSS).
authors.affiliation: Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.|Department of Breast Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
authors.forename: Michael Tvilling
authors.initials: MT
authors.lastname: Madsen
authors.affiliation: Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.|Department of Breast Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
authors.forename: Melissa Voigt
authors.initials: MV
authors.lastname: Hansen
authors.affiliation: Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.|Department of Breast Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
authors.forename: Lærke Toftegård
authors.initials: LT
authors.lastname: Andersen
authors.affiliation: Psychiatric Centre Copenhagen, Rigshospitalet, University of Copenhagen, København N, Denmark.
authors.forename: Ida
authors.initials: I
authors.lastname: Hageman
authors.affiliation: Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, København N, Denmark.
authors.forename: Lars Simon
authors.initials: LS
authors.lastname: Rasmussen
authors.affiliation: Department of Breast Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
authors.forename: Susanne
authors.initials: S
authors.lastname: Bokmand
authors.affiliation: Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
authors.forename: Jacob
authors.initials: J
authors.lastname: Rosenberg
authors.affiliation: Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
authors.forename: Ismail
authors.initials: I
authors.lastname: Gögenur
mesh_terms: D056044:Actigraphy; D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000523:psychology / Q000601:surgery*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D008550:Melatonin / Q000627:therapeutic use*; D008875:Middle Aged; D059035:Perioperative Period / Q000009:adverse effects; D012890:Sleep / Q000187:drug effects*; D064232:Visual Analog Scale
chemical_list: D006993:Hypnotics and Sedatives; D008550:Melatonin
keywords: actigraphy; breast cancer surgery; melatonin; randomized clinical trial; sleep