The effects of humor therapy on nursing home residents measured using observational methods: the SMILE cluster randomized trial.

OBJECTIVES: To evaluate the effects of humor therapy assessed using observational methods on agitation, engagement, positive behaviors, affect, and contentment. DESIGN: Single-blind cluster randomized controlled trial. SETTING: A total of 35 Sydney nursing homes. PARTICIPANTS: All eligible residents within geographically defined areas within each nursing home were invited to participate. INTERVENTION: Professional "ElderClowns" provided 9 to 12 weekly humor therapy sessions, augmented by resident engagement by trained staff "LaughterBosses." Controls received usual care. MEASUREMENTS: The Behavior Engagement Affect Measure (BEAM) touchpad observational tool was used to capture real-time behavioral data. The tool assesses the duration in seconds of agitation, positive behavior toward others, engagement, and affect (angry, anxious, happy, neutral, sad). RESULTS: Seventeen nursing homes (189 residents) received the intervention and 18 homes (209 residents) received usual care. Over 26 weeks, in comparison with controls, the humor therapy group decreased in duration of high agitation (effect size = 0.168 and 0.129 at 13 and 26 weeks, respectively) and increased in duration of happiness (effect size = 0.4 and 0.236 at 13 and 26 weeks, respectively). CONCLUSION: We confirmed that humor therapy decreases agitation and also showed that it increases happiness. Researchers may consider evaluating impacts of nonpharmaceutical interventions on positive outcomes. Computer-assisted observational measures should be considered, particularly for residents with dementia and when the reliability of staff is uncertain.

Successful ingredients in the SMILE study: resident, staff, and management factors influence the effects of humor therapy in residential aged care.

OBJECTIVE: To test the hypothesis that individual and institutional-level factors influence the effects of a humor therapy intervention on aged care residents. METHODS: Data were from the humor therapy group of the Sydney Multisite Intervention of LaughterBosses and ElderClowns, or SMILE, study, a single-blind cluster randomized controlled trial of humor therapy conducted over 12 weeks; assessments were performed at baseline, week 13, and week 26. One hundred eighty-nine individuals from 17 Sydney residential aged care facilities were randomly allocated to the humor therapy intervention. Professional performers called "ElderClowns" provided 9-12 weekly humor therapy 2-hour sessions, augmented by trained staff, called "LaughterBosses." Outcome measures were as follows: Cornell Scale for Depression in Dementia, Cohen-Mansfield Agitation Inventory, Neuropsychiatric Inventory, the withdrawal subscale of Multidimensional Observation Scale for Elderly Subjects, and proxy-rated quality of life in dementia population scale. Facility-level measures were as follows: support of the management for the intervention, commitment levels of LaughterBosses, Environmental Audit Tool scores, and facility level of care provided (high/low). Resident-level measures were engagement, functional ability, disease severity, and time-in-care. Multilevel path analyses simultaneously modeled resident engagement at the individual level (repeated measures) and the effects of management support and staff commitment to humor therapy at the cluster level. RESULTS: Models indicated flow-on effects, whereby management support had positive effects on LaughterBoss commitment, and LaughterBoss commitment increased resident engagement. Higher resident engagement was associated with reduced depression, agitation, and neuropsychiatric scores. CONCLUSION: Effectiveness of psychosocial programs in residential aged care can be enhanced by management support, staff commitment, and active resident engagement.

The Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) study: cluster randomised trial of humour therapy in nursing homes.

OBJECTIVES: To determine whether humour therapy reduces depression (primary outcome), agitation and behavioural disturbances and improves social engagement and quality-of-life in nursing home residents. DESIGN: The Sydney Multisite Intervention of LaughterBosses and ElderClowns study was a single-blind cluster randomised controlled trial of humour therapy. SETTING: 35 Sydney nursing homes. PARTICIPANTS: All eligible residents within geographically defined areas within each nursing home were invited to participate. INTERVENTION: Professional 'ElderClowns' provided 9-12 weekly humour therapy sessions, augmented by resident engagement by trained staff 'LaughterBosses'. Controls received usual care. MEASUREMENTS: Depression scores on the Cornell Scale for Depression in Dementia, agitation scores on the Cohen-Mansfield Agitation Inventory, behavioural disturbance scores on the Neuropsychiatric Inventory, social engagement scores on the withdrawal subscale of Multidimensional Observation Scale for Elderly Subjects, and self-rated and proxy-rated quality-of-life scores on a health-related quality-of-life tool for dementia, the DEMQOL. All outcomes were measured at the participant level by researchers blind to group assignment. RANDOMISATION: Sites were stratified by size and level of care then assigned to group using a random number generator. RESULTS: Seventeen nursing homes (189 residents) received the intervention and 18 homes (209 residents) received usual care. Groups did not differ significantly over time on the primary outcome of depression, or on behavioural disturbances other than agitation, social engagement and quality of life. The secondary outcome of agitation was significantly reduced in the intervention group compared with controls over 26 weeks (time by group interaction adjusted for covariates: p=0.011). The mean difference in change from baseline to 26 weeks in Blom-transformed agitation scores after adjustment for covariates was 0.17 (95% CI 0.004 to 0.34, p=0.045). CONCLUSIONS: Humour therapy did not significantly reduce depression but significantly reduced agitation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry -ACTRN12611000462987.

Study protocol for a randomized controlled trial of humor therapy in residential care: the Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE).

BACKGROUND: Humor therapy is a non-pharmacological intervention with potential to improve mood and quality of life for institutionalized older persons, including those with dementia. The primary aims of the Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) are to examine the effects of humor therapy on residents' mood, quality of life, social engagement, and agitation. METHODS: SMILE is a single-blinded cluster-randomized controlled trial where 398 consented residents in 35 residential aged care facilities will be allocated to receive humor therapy or usual care. Residents allocated to the intervention group will engage in humor therapy with professional performers (ElderClowns) and trained facility staff (LaughterBosses) for a minimum of nine two-hour sessions over 12 weeks as well as engaging humorously with LaughterBosses during the course of daily care. The usual care control group will not engage in any formal humor therapy. Researchers, blind to treatment allocation, will assess residents at baseline (week 0), post-intervention (week 13), and follow-up (week 26). The measurement suite includes the Cornell Scale for Depression in Dementia, the Dementia Quality of Life Scale, the Multidimensional Observation Scale for Elderly Subjects, the Cohen-Mansfield Agitation Inventory, and the Neuropsychiatric Inventory. Observations of residents' engagement will be recorded at each humor therapy session. CONCLUSIONS: SMILE is the first large rigorous study of humor therapy in aged care.

Paediatric oncology patient preference for oral nutritional supplements in a clinical setting.

PURPOSE: Oral nutrition supplements are commonly used to increase the nutrient intake of children who are undergoing treatment for cancer. However, little research has been conducted systematically examining preferences for oral supplements in this population. This study aims to address a gap in the literature by examining taste preferences of oral nutrition supplements routinely recommended for children undergoing treatment for cancer. METHODS: Twenty-one children undergoing treatment for cancer and 38 healthy control subjects participated in an acute double-blinded feeding trial. A variety of energy drinks, available both commercially and in the hospital, were sampled. Patients rated the taste of the drinks on a 10-cm coloured analogue scale. RESULTS: A commercially-based drink (Moove™) rated the highest in the blinded and branded tests for the treatment (mean rating out of 10, 6.44±2.69 and 7.26±2.33, respectively) and control groups (mean rating, 7.61±1.91 and 7.70±2.32, respectively). Taste ratings were significantly higher for commercially available supplements over the hospital-prepared supplements, (p=0.041), with no main effect for tasting condition (i.e. blinded versus branded, p=0.902). There was a statistically significant trend such that ratings, when the brand that was known decreased for hospital supplements, while ratings for commercially available supplements increased (p=0.014). CONCLUSION: Fresh milk-based supplements were the preferred type of oral nutrition supplement in a cohort of paediatric oncology patients. The data also suggest that commercially available products are more likely to be accepted than hospital-prepared supplements. This pilot study supports the need for further research in the area of oral nutrition supplements for paediatric oncology patients as a way of determining a reliable way to estimate preferences and therefore maximise compliance. Results from this research could be also used as the basis for designing research to study the effects of flavour fatigue and long-term compliance with oral nutrition supplements in this population.

Effects of attentional direction, age, and coping style on cold-pressor pain in children.

This study assessed the relative efficacy of two imagery-based attentional strategies for modifying pain experience in children. Children aged 7-14 years (n = 120) were randomly assigned to one of three conditions: distraction, sensory-focussing or control (no imagery). The distraction condition prompted children to focus their attention externally; the sensory-focussing condition prompted the child to focus internally on physical sensations. Self-report measures of pain coping style preferences and imagery ability were completed. Children's pain tolerance and perceptions of pain intensity were assessed using a 10 degrees C cold-pressor task. Results showed pain intensity ratings after 1 min were lower for both intervention conditions than for the controls. Younger children (7-9 years) showed higher pain tolerance in the distraction condition than in the sensory-focussing condition, whereas both interventions were equally effective for older children (10-14 years). Among older children, coping style interacted with the intervention type: in the sensory-focussing condition, pain tolerance was negatively associated with self-reported distraction-based coping style, whereas in the distraction condition this association was positive. The results are interpreted with reference to current models of attention. The implications for use of attentional strategies in helping children to cope with clinical pain are discussed.