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Randomized Controlled Trial
. 2018 Nov 27;17(1):125.
doi: 10.1186/s12904-018-0378-1.

A randomised controlled pilot and feasibility study of music therapy for improving the quality of life of hospice inpatients

Sam Porter  1 , Tracey McConnell  2 , Lisa Graham-Wisener  3 , Joan Regan  3 , Miriam McKeown  3 , Jenny Kirkwood  4 , Mike Clarke  5 , Evie Gardner  6 , Saskie Dorman  7 , Kerry McGrillen  3 , Joanne Reid  8
Affiliations
Randomized Controlled Trial

A randomised controlled pilot and feasibility study of music therapy for improving the quality of life of hospice inpatients

Sam Porter et al. BMC Palliat Care. .

Abstract

Background: Evidence about the effectiveness of music therapy for improving the quality of life of palliative care patients is positive but weak in terms of risk of bias.

Methods: This study aimed to determine the feasibility of a randomised controlled trial to evaluate the effectiveness of music therapy for improving the quality of life of hospice inpatients, as measured by the McGill Quality of Life questionnaire. Objectives included recruitment of 52 participants over 12 months and provision of data to support the calculation of the required sample size for a definitive randomised trial, taking into account the retention rates of recruited participants; and evaluation of the viability of the intervention and the acceptability of the assessment tool. The design was a single-centre, researcher-blinded randomised pilot and feasibility study involving two parallel groups. Participants were recruited from one inpatient hospice unit in Northern Ireland. Eligibility criteria were an Eastern Cooperative Oncology Group performance status of two or lower and an Abbreviated Mental Test score of seven or more. Consenting patients were randomly allocated to the intervention or control group using a 1:1 allocation ratio. The intervention group received up to six individual music therapy sessions over 3 weeks in addition to usual care. The control group received usual care only.

Results: Fifty one participants were recruited over 12 months. Twenty five were allocated to the intervention group and 26 to the control group. Seventy one percent of participants were lost to follow up by week 3, the proposed primary endpoint. The primary endpoint was moved from week 3, when 71% were lost to follow up to week 1, when 33% were lost. The McGill Quality of Life questionnaire was generally acceptable to participants. In order to detect a small to moderate effect size of 0.3, a fully powered study would require the recruitment of 698 participants.

Conclusions: A Phase III randomised controlled trial to evaluate the effectiveness of music therapy in improving the quality of life of hospice inpatients is feasible.

Trial registration: ClinicalTrials.gov: NCT02791048 . Registered 6 June 2016.

Keywords: End-of-life; Feasibility; Hospice; Music therapy; Palliative; Pilot; Quality of life.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval was provided from the Office of Research Ethics Committee Northern Ireland (ORECNI) (reference number 16/NI/0058), which also provided approval for alterations to the protocol made during the study. Patients and staff provided written informed consent prior to participation in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Patient flow through the study
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