Effectiveness Not Established

Nevasic Audio

for Chemotherapy-Induced Nausea and Vomiting—Adult

Nevasic is an audio program that is believed to work by emitting specific tones, frequencies, and pulses that disrupt normal auditory signals at the vestibular level, affecting balance receptors and creating an antiemetic reaction. Nevasic originally was developed as an audio tape and has been used for symptoms such as morning sickness and motion sickness. Nevasic audio was examined for its effects on chemotherapy-induced nausea and vomiting in patients with cancer.

Research Evidence Summaries

Moradian, S., Walshe, C., Shahidsales, S., Ghavam Nasiri, M.R., Pilling, M., & Molassiotis, A. (2014). Nevasic audio program for the prevention of chemotherapy induced nausea and vomiting: A feasibility study using a randomized controlled trial design. European Journal of Oncology Nursing, 19, 282–291. 

Study Purpose

To examine the feasibility of implementing and conducting a randomized controlled trial to assess the effects of Nevasic on chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Nevasic, a medical device, is an audio program that generates an antiemetic reaction. Nevasic is thought to work by emitting specific constructed tones, frequencies, and pulses that disrupt the normal auditory signal chain at the vestibular level, affecting the experience of nausea and vomiting.

This study was a pilot, multicenter, randomized, controlled trial with three parallel arms (intervention, attention, and control) in Mashhad, Iran. After randomization, all participants were given the treatment progression questionnaire. Those in the intervention and attention groups also were issued a CD player and headphones with the Nevasic program or music files. Patients could keep the equipment at the end of the study. The procedure for the intervention and attention groups were identical except that those in the Nevasic intervention group listened to the active intervention of Nevasic, and those in the attention group listened to preselected music. Participants were given clear instructions on the use of the Nevasic program or the music, which included: only listening through the headphones provided; listening to Nevasic or the music immediately once they started feeling nauseous or vomiting during or after chemotherapy administration; listening to the Nevasic or music program all the way through the 27 minutes or till they felt symptoms diminished; and not skipping any part of the Nevasic or music program. They were instructed to repeat these stages if their symptoms returned. The duration of the intervention or attention was six days. Participants in all three groups were told to take their antiemetics after chemotherapy as prescribed. The participants were instructed in the completion of the measures and follow-up questionnaire. They were asked to return the measures and questionnaires using prepaid, selfaddressed envelopes.

Sample Characteristics

  • N = 99 (Nevasic Arm: 34, Music Arm: 32, Control Arm; 33)  
  • MEAN AGE RANGE = 46–51 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer

Setting

  • SITE: Single site
  • SETTING TYPE: Not specified    
  • LOCATION: Mashhad, Iran

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Pilot, multicenter, randomized, controlled trial with three parallel arms (intervention, attention, and control)

Measurement Instruments/Methods

  • The frequency and duration of nausea and the amount of vomiting was measured using the translated (Persian) version of Rhodes Index of Nausea, Vomiting, and Retching (INVR).
  • Health-related quality of life (HR-QOL) was measured with the validated Iranian version of the European Organization Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and EORTC QLQ-BR23 (Safaee and Dehkordi, 2007).

Results

Effectiveness of Nevasic in Managing CINV
 
A linear mixed-effects model was conducted to explore the impact of the interventions on nausea and vomiting scores at different times (time 0 [before chemotherapy] to time 6 [day 6 postchemotherapy]). There was no statistically significant difference in nausea or vomiting experience scores between the three groups.
 
Effects on Patients’ HR-QOL
 
The results show that there was a borderline nonsignificant result for global health status.

Conclusions

Based on these study results, Nevasic is not an effective treatment in the management of CINV. The researchers stated that the findings from the trial highlight the need for several modifications to the design and the mode of intervention delivery.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Other limitations/explanation: First, this feasibility trial was not powered to detect statistically significant differences between groups. Second, no blinding was used for this study, and participants were aware of which arm they were in.

Nursing Implications

Based on these study results, Nevasic is not an effective nonpharmacologic treatment technique to control or manage CINV.

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