Measuring implementation fidelity in a cluster-randomized pragmatic trial: development and use of a quantitative multi-component approach

Background In pragmatic trials, on-site partners, rather than researchers, lead intervention delivery, which may result in implementation variation. There is a need to quantitatively measure this variation. Applying the Framework for Implementation Fidelity (FIF), we develop an approach for measuring variability in site-level implementation fidelity. This approach is then applied to measure site-level fidelity in a cluster-randomized pragmatic trial of Music & MemorySM (M&M), a personalized music intervention targeting agitated behaviors in residents living with dementia, in US nursing homes (NHs). Methods Intervention NHs (N = 27) implemented M&M using a standardized manual, utilizing provided staff trainings and iPods for participating residents. Quantitative implementation data, including iPod metadata (i.e., song title, duration, number of plays), were collected during baseline, 4-month, and 8-month site visits. Three researchers developed four FIF adherence dimension scores. For Details of Content, we independently reviewed the implementation manual and reached consensus on six core M&M components. Coverage was the total number of residents exposed to the music at each NH. Frequency was the percent of participating residents in each NH exposed to M&M at least weekly. Duration was the median minutes of music received per resident day exposed. Data elements were scaled and summed to generate dimension-level NH scores, which were then summed to create a Composite adherence score. NHs were grouped by tercile (low-, medium-, high-fidelity). Results The 27 NHs differed in size, resident composition, and publicly reported quality rating. The Composite score demonstrated significant variation across NHs, ranging from 4.0 to 12.0 [8.0, standard deviation (SD) 2.1]. Scaled dimension scores were significantly correlated with the Composite score. However, dimension scores were not highly correlated with each other; for example, the correlation of the Details of Content score with Coverage was τb = 0.11 (p = 0.59) and with Duration was τb = − 0.05 (p = 0.78). The Composite score correlated with CMS quality star rating and presence of an Alzheimer’s unit, suggesting face validity. Conclusions Guided by the FIF, we developed and used an approach to quantitatively measure overall site-level fidelity in a multi-site pragmatic trial. Future pragmatic trials, particularly in the long-term care environment, may benefit from this approach. Trial registration Clinicaltrials.gov NCT03821844. Registered on 30 January 2019, https://clinicaltrials.gov/ct2/show/NCT03821844.

Impact of Music Intervention (Listening to Indian Classical Music) on Mental Wellbeing during COVID-19 Pandemic

Background: Reports show that mental wellbeing may be negatively affected by the COVID-19 pandemic. The ragas of Indian classical music are believed to have therapeutic effects. This study was done to investigate the impact of an Indian raga on mental wellbeing during the COVID-19 pandemic. Materials and Methods: It was a one-group before-after design study. A total of 45 adult subjects of Kolkata, recruited online, using convenience sampling during the lockdown, underwent a pre-test via Google forms using Warwick-Edinburg Mental Wellbeing Scale (WEMWBS) to evaluate mental wellbeing before the administration of music intervention. After two weeks of music intervention, that consisted of passively listening to raga Hamsadhwani, a post-test using the same scale and the same medium was done. Results: The results showed that the post-test mean of the total score 51.1 (SD = 3.9) of WEMWBS was significantly (p< 0.001) higher than the pre-test mean of the total score 30.9 (SD = 4.6). The same trend was reflected by the mean difference pertaining to all of the components of WEMWBS. Conclusion: It was concluded that raga Hamsadhwani may be effective in improving mental wellbeing in a pandemic situation. There is a need to do more work by improvising the research design employed in the present study. This will help to interpret more accurately and more meaningfully the effects of Indian raga music on mental wellbeing.

Effects of a group music-based intervention in improving attachment and psychosocial adaptation in adolescents with parental attachment insecurity: A randomized trial

The effects of a group music-based intervention on attachment and psychosocial adaptation in adolescents with parental attachment insecurity were examined in Taiwan. A randomized controlled trial with a pre–post and follow-up design was performed. The music group ( N = 28) attended a 40-min session twice weekly for 10 weeks. The nonmusic group ( N = 28) received health education. The groups underwent a parental attachment and psychosocial adaptation assessment before and after the music intervention and at the 1-week follow-up. The results were analyzed using paired-samples t-tests and a mixed analysis of variance. Fifty-four participants completed both the pre- and posttests and were included in the final data analysis. The interaction effect was statistically significant, parental attachment, F(1.07, 25.81) = 8.18, p < .005, η2 = .14; and psychosocial maladaptation, F(1.30, 31.93) = 8.01, p < .01, η2 = .13, scores, implying a successful intervention. A significant difference in the postintervention parental attachment, F(1.03, 25.81) = 19.19, p < .001, and psychosocial maladaptation, F(1.28, 31.93) = 14.22, p < .001, scores was found between the music and nonmusic groups. The present study confirmed that group music-based interventions may effectively improve adolescents’ parental attachment and mitigate their psychosocial maladaptation.

Effect of specific melodic scales of Indian music in reducing state and trait anxiety: A randomized clinical trial

Music is an aesthetic stimulus that evokes a subjective experience in every individual involved with it. Music as a modality to reduce anxiety and stress has been researched scientifically across the world, but evidence regarding Indian musical scales (ragas) is meager. Healthy individuals were randomly divided into four groups where three groups—A ( Ahir Bhairav), B ( Kaunsi Kanada), and C ( Bhimpalas)—received a music intervention (10 min) while Group D was the control group. Anxiety was scored using the State-Trait Anxiety Inventory (STAI) before and after the intervention. Data analysis was done using analysis of covariance (ANCOVA). All three scales reduced STAI scores significantly, with Scale B causing the maximum reduction in the score. After adjusting for the pre-trait scores, it was observed that age ( p = .002) and gender ( p = .018) affected the post-trait scores. A regression analysis on gender showed a significant association of trait scores in Group C ( p = .01; odds ratio [OR] = 0.125). Scales A and C had more beneficial effects in females while Scale B was beneficial among males. Thus, listening to any of the three chosen Indian scales reduced anxiety. Listening to music does have therapeutic implications for anxious and stressed individuals.

Using a Portable Gait Rhythmogram to Examine the Effect of Music Therapy on Parkinson’s Disease-Related Gait Disturbance

External cues improve walking by evoking internal rhythm formation related to gait in the brain in patients with Parkinson’s disease (PD). This study examined the usefulness of using a portable gait rhythmogram (PGR) in music therapy on PD-related gait disturbance. A total of 19 subjects with PD who exhibited gait disturbance were evaluated for gait speed and step length during a 10 m straight walking task. Moreover, acceleration, cadence, and trajectory of the center of the body were estimated using a PGR. Walking tasks were created while incorporating music intervention that gradually increased in tempo from 90 to 120 beats per minute (BPM). We then evaluated whether immediate improvement in gait could be recognized even without music after walking tasks by comparing pre- (pre-MT) and post-music therapy (post-MT) values. Post-MT gait showed significant improvement in acceleration, gait speed, cadence, and step length. During transitions throughout the walking tasks, acceleration, gait speed, cadence, and step length gradually increased in tasks with music. With regard to the trajectory of the center of the body, we recognized a reduction in post-MT medio-lateral amplitude. Music therapy immediately improved gait disturbance in patients with PD, and the effectiveness was objectively shown using PGR.

Music intervention affects the quality of life on Alzheimer’s disease: a meta-analysis

Review question / Objective: Inclusion criteria: population: 1) A randomized controlled study on the impact of music intervention on the QOL of patients with AD; 2) The participants in this study is patients with AD; 3) There is no significant difference among age, gender and education background in sorted groups before analysis which make these groups comparable; intervention: 1)Intervention Modality Music-based intervention; comparison: 1) All data were sorted into two groups: the music intervention group and the control group without any music intervention; outcome: 1) The indicators evaluated in the literature included the score of QOL-AD or WHOQOL-BERF scale, at least one of the two scales summarized in selected publications; language: 1) Only articles published in English and Chinese were considered. Exclusion criteria: 1) The participants were not diagnosed with AD; 2) Non-musical intervention;3) Non-RCTs; 4) No specific values for outcome variables; 5) Articles lacking original data; 6) Repeat published reports; 7) Full text could not be obtained.

Effect of specific melodic scales of Indian music in reducing state and trait anxiety – a randomized clinical trial

Music is an aesthetic stimulus that evokes a subjective experience in every individual involved in it. Music as a modality to reduce anxiety and stress has been researched scientifically across the world, but evidence regarding Indian musical scales (ragas) is meager. Healthy individuals were randomly divided into 4 groups where 3 groups [A(Ahir bhairav), B (Kaunsi Kanada), C (Bhimpalas)] received music intervention (10 minutes) while Group D was the control group. Anxiety was scored using State trait anxietyinventory (STAI) before and after the intervention.

Implementing a Personalized Music Intervention for Persons Living With Dementia in Nursing Facilities

The Mason Music & Memory Initiative (M3I) team has implemented a personalized music intervention in nursing facilities across Virginia aiming to improve behavioral and psychological symptoms of persons living with dementia. This person-centered intervention uses a unique music playlist comprising songs, artists, and preferred musical genres. The preliminary findings from a randomized controlled trial will be reported, the purpose of which was to examine the intervention impact on nursing home residents’ mood and behavior. Based on the findings from 16 facilities with 158 residents who have completed the study, both quantitative and qualitative data indicate the positive effects on residents, including improved sleep and mood, as well as reduced agitation. The challenges in implementing intervention research in nursing facilities during the COVID-19 pandemic and the principles of telehealth and virtual support for facilities that were used to address those challenges will also be discussed.

An Intergenerational Zoom Music Therapy Group During COVID-19

The COVID-19 pandemic has led to an increase in ageist attitudes and psychological distress and loneliness among older people. The social isolation exacerbated the intergenerational segregation between young and older adults, and has also been expressed within families, since grandparents could not meet their grandchildren in person. The present study involved an intergenerational music intervention, as a vehicle to bridge the gap between grandparents and grandchildren at the COVID-19 pandemic. 41 grandparents aged 56-80, and 45 grandchildren aged 9.9-11.8 took part. Of these, 21 pairs of grandparents and grandchildren participated in a weekly online intergenerational zoom music therapy group for eight weeks, and the rest constituted a waitlist-controlled group. All participants completed the same questionnaires during the same time periods before and after the intervention. The results point to the effectiveness of participation in the sessions in improving intergenerational connections and psychological well-being, and in reducing ageist attitudes and loneliness.

Effect of music on clinical outcome after hip fracture operations (MCHOPIN): study protocol of a multicentre randomised controlled trial

BackgroundPatients undergoing proximal femur fracture surgery are at high risk of postoperative complications, with postoperative delirium occurring in 25%–40% of patients. Delirium has profound effects on patient outcome and recovery, the patient’s family, caregivers and medical costs. Perioperative music has a beneficial effect on eliciting modifiable risk factors of delirium. Therefore, the aim of this trial was to evaluate the effect of perioperative recorded music on postoperative delirium in patients with proximal femur fracture undergoing surgery.Methods and analysisThe Music on Clinical Outcome after Hip Fracture Operations study is an investigator-initiated, multicentre, randomised controlled, open-label, clinical trial. Five hundred and eight patients with proximal femur fracture meeting eligibility criteria will be randomised to the music intervention or control group with concealed allocation in a 1:1 ratio, stratified by hospital site. The perioperative music intervention consists of preselected lists totalling 30 hours of music, allowing participants to choose their preferred music from these lists (classical, jazz and blues, pop and Dutch). The primary outcome measure is postoperative delirium rate. Secondary outcome measures include pain, anxiety, medication requirement, postoperative complications, hospital length of stay and 30-day mortality. A 90-day follow-up will be performed in order to assess nursing home length of stay, readmission rate and functional ability to perform daily living activities. Furthermore, the cost and cost-effectiveness of the music intervention will be assessed. Data will be analysed according to an intention-to-treat principle.Ethics and disseminationThe study protocol has been approved by the Medical Research Ethics Committee Erasmus MC on 8 October 2018 (MEC-2018–110, NL64721.078.18). The trial will be carried out following the Declaration of Helsinki principles, Good Clinical Practice guidelines and Dutch Medical Research Involving Human Subjects Act. Research data will be reported following Consolidated Standards of Reporting Trials guidelines and study results will be published in a peer-reviewed journal.Trial registration numberNTR7036.