title: Nevasic audio program for the prevention of chemotherapy induced nausea and vomiting: A feasibility study using a randomized controlled trial design.
abstract: OBJECTIVE
  Pharmacological therapy is only partially effective in preventing or treating chemotherapy induced nausea and vomiting (CINV). Therefore, exploring the complementary role of non-pharmacological approaches used in addition to pharmacological agents is important. Nevasic uses specially constructed audio signals hypothesized to generate an antiemetic reaction. The aim of this study was to examine the feasibility of conducting a randomized controlled trial (RCT) to evaluate the effectiveness of Nevasic to control CINV.
  
  
  METHODS
  A mixed methods design incorporating an RCT and focus group interviews. For the RCT, female breast cancer patients were randomized to receive either Nevasic plus usual care, music plus usual care, or usual care only. Data were analysed using descriptive statistics and linear mixed-effects models. Five focus group interviews were conducted to obtain participants' views regarding the acceptability of the interventions in the trial.
  
  
  RESULTS
  99 participants were recruited to the RCT and 15 participated in focus group interviews. Recruitment targets were achieved. Issues of Nevasic acceptability were highlighted as weaknesses of the program. This study did not detect any evidence for the effectiveness of Nevasic; however, the results showed statistically significant less use of anti-emetics (p = 0.003) and borderline non-significant improvement in quality of life (p = 0.06).
  
  
  CONCLUSIONS
  Conducting a non-pharmacological intervention using such an audio program is feasible, although difficulties and limitations exist with its use. Further studies are required to investigate the effectiveness of Nevasic from perspectives such as anti-emetic use, as well as its overall effect on the levels of nausea and vomiting.
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK. Electronic address: dr.smoradian@gmail.com.
authors.forename: Saeed
authors.initials: S
authors.lastname: Moradian
authors.affiliation: International Observatory on End of Life Care, Division of Health Research, Lancaster University, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Walshe
authors.affiliation: Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Soodabeh
authors.initials: S
authors.lastname: Shahidsales
authors.affiliation: Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Mohammad Reza
authors.initials: MR
authors.lastname: Ghavam Nasiri
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Pilling
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK; School of Nursing, The Hong Kong Polytechnic University, Hong Kong.
authors.forename: Alexander
authors.initials: A
authors.lastname: Molassiotis
mesh_terms: D000328:Adult; D000932:Antiemetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007492:Iran; D008875:Middle Aged; D009147:Music Therapy; D009325:Nausea / Q000139:chemically induced / Q000628:therapy*; D010865:Pilot Projects; D011788:Quality of Life; D014839:Vomiting / Q000139:chemically induced / Q000628:therapy*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents
keywords: Chemotherapy-induced nausea and vomiting; Feasibility; Music therapy; Nevasic