title: Touch massage: a pilot study of a complex intervention.
abstract: OBJECTIVE
  To report and evaluate a complex touch massage intervention according to the British Medical Research Council framework. This study aimed to evaluate the effects of touch massage on levels of anxiety and physiological stress in patients scheduled for elective aortic surgery.
  
  
  BACKGROUND
  The use of touch massage has increased during the past decade but no systematic studies have been implemented to investigate the effectiveness of such treatment. It is important to conduct multidisciplinary investigations into the effects of complex interventions such as touch massage. For this, the British Medical Research Council has provided a useful framework to guide the development, piloting, evaluation and reporting of complex intervention studies.
  
  
  METHODS
  A pilot study with a randomized controlled design including 20 patients (10 + 10) scheduled for elective aortic surgery. Selected outcome parameters included; self-reported anxiety, measured by the State-Trait Anxiety Inventory Form Y instrument, and physiological stress, measured by heart rate variability, blood pressure, respiratory frequency, oxygen saturation and concentrations of cortisol, insulin and glucose in serum.
  
  
  RESULTS
  There were significant differences in self-reported anxiety levels before and after touch massage (p = 0.007), this was not observed in the control group (p = 0.833). There was a significant difference in self-reported anxiety levels between the touch massage group and the control group after touch massage and rest (p = 0.001). There were no significant differences in physiological stress-related outcome parameters between patients who received touch massage and controls.
  
  
  CONCLUSIONS
  In our study, touch massage decreased anxiety levels in patients scheduled for elective aortic surgery, and the British Medical Research Council framework was a useful guideline for the development, evaluation and reporting of a touch massage intervention.
  
  
  CONCLUSIONS
  Touch massage can reduce patients' anxiety levels and is thus an important nursing intervention in intensive and post-operative care.
authors.affiliation: L Lindgren, RN, MSn, PhD, Department of Nursing, Umeå University and Department of Surgical and Perioperative Science Anesthesiology and Intensive Care, Umeå, Sweden.
authors.forename: Lenita
authors.initials: L
authors.lastname: Lindgren
authors.forename: Stefan
authors.initials: S
authors.lastname: Lehtipalo
authors.forename: Ola
authors.initials: O
authors.lastname: Winsö
authors.forename: Marcus
authors.initials: M
authors.lastname: Karlsson
authors.forename: Urban
authors.initials: U
authors.lastname: Wiklund
authors.forename: Christine
authors.initials: C
authors.lastname: Brulin
mesh_terms: D000368:Aged; D001007:Anxiety / Q000097:blood / Q000523:psychology*; D001018:Aortic Diseases / Q000601:surgery*; D001794:Blood Pressure / Q000502:physiology; D017558:Elective Surgical Procedures; D055318:Evidence-Based Nursing; D005215:Fasting / Q000097:blood; D006339:Heart Rate / Q000502:physiology; D006801:Humans; D007362:Intensive Care Units; D008405:Massage; D008875:Middle Aged; D010100:Oxygen / Q000378:metabolism; D010865:Pilot Projects; D057566:Self Report; D018709:Statistics, Nonparametric; D013312:Stress, Physiological / Q000502:physiology*; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D010100:Oxygen
keywords: Adult intensive care; Care nursing; Clinical research; Complex interventions; Intensive; Psychological care of patients; Research