Effect of Soundscape Augmentation on Behavioral Symptoms in People With Dementia: A Pilot Randomized Controlled Trial

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Abstract

Background and Objectives

Sound is an important environmental factor that influences the expression of behavioral and psychological symptoms of dementia. Recent research on the effect of soundscape has shown promising results in improving environmental impact on people with dementia. However, no controlled studies have aimed to quantify the effects of soundscape intervention on resident outcomes. The aim of this study was to assess the feasibility and impact of a soundscape intervention on people with dementia and behavioral symptoms.

Research Design and Methods

Pilot single-blind repeated-measures randomized controlled trial of an augmented soundscape intervention. Participants were people with dementia in a hospital-based specialized dementia unit. Participants were randomized to an augmented soundscape intervention delivered in their room in the morning and evening or treatment as usual, with 2 baseline weeks and 4 weekly post-randomization assessments of the primary and secondary behavioral outcomes.

Results

The soundscape intervention was feasible in terms of recruitment, retention, and delivery of the intervention. There were improvements in the neuropsychiatric inventory total scores over time in both groups (−5.89, 95%CI −8.45 to −3.28, p < .001), but no differences between groups. There were no significant group, time, or group × time differences for the Pittsburgh Agitation Scale (PAS) total score. For the PAS-resisting care subscale, there was a significant group × time difference, with a greater reduction in the soundscape group over the study period (−0.81, 95% CI −1.59 to −0.03, p = .042).

Discussion and Implications

In this pilot study, soundscape augmentation was a feasible and effective nonpharmacological approach to reducing resistance to care in people with dementia, although it did not improve neuropsychiatric symptoms more globally. Further studies with larger samples and of longer duration are needed to investigate the long-term effects of augmented sonic environments on people with dementia.

Clinical Trials Registration Number

NCT04809545

Related collections

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CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Sandra M. Eldridge, Claire L Chan, Michael J Campbell … (2017)

The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.

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Author and article information

Contributors

Arezoo Talebzadeh

Dick Botteldooren

Pieter Thomas

Steven Stewart

Dominique Van de Velde

Patricia De Vriendt

Paul Devos

Andrea Iaboni:

ORCID: https://orcid.org/0000-0003-4268-6832

Amanda N Leggett: Role: Decision Editor

Journal

Journal ID (nlm-ta): Innov Aging

Journal ID (iso-abbrev): Innov Aging

Journal ID (publisher-id): innovateage

Title: Innovation in Aging

Publisher: Oxford University Press (US )

ISSN (Electronic): 2399-5300

Publication date Collection: 2024

Publication date (Electronic): 05 August 2024

Publication date PMC-release: 05 August 2024

Volume: 8

Issue: 9

Electronic Location Identifier: igae069

Affiliations

Department of Information Technology, WAVES—Ghent University , Ghent, Belgium

KITE—Toronto Rehabilitation Institute, University Health Network , Toronto, Ontario, Canada

Faculty of Mediciness and Health Care Sciences, Department of Rehabilitation Sciences, Occupational Therapy Research Group, Ghent University , Ghent, Belgium

Occupational Therapy Department, Artevelde University of Applied Sciences , Ghent, Belgium

Department of Information Technology, WAVES—Ghent University , Ghent, Belgium

KITE—Toronto Rehabilitation Institute, University Health Network , Toronto, Ontario, Canada

Temerty Faculty of Medicine, Department of Psychiatry, University of Toronto , Toronto, Ontario, Canada

Author notes

Address correspondence to: Andrea Iaboni, MD, DPhil. E-mail: andrea.iaboni@ 123456uhn.ca

Author information

Andrea Iaboni https://orcid.org/0000-0003-4268-6832

Article

Publisher ID: igae069

DOI: 10.1093/geroni/igae069

PMC ID: 11441324

PubMed ID: 39350940

SO-VID: b045d7ed-f567-4afb-ad2f-134d45213686

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

History

Date received : 27 February 2024

Date: 30 June 2024

Date: 30 September 2024

Page count

Pages: 10

Funding

Funded by: HEAD-Genuit-Stiftung, DOI 10.13039/501100015717;

Award ID: P-19/04-W

Funded by: Ghent University, DOI 10.13039/501100004385;

Funded by: Walter & Maria Schroeder Institute for Brain Innovation and Recovery;

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