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AbstractObjectiveTo assess efficacy and safety of laughter exercise in patients with symptomatic dry eye disease.DesignNon-inferiority randomised controlled trial.SettingRecruitment was from clinics and community and the trial took place at Zhongshan Ophthalmic Center, Sun Yat-sen University, the largest ophthalmic centre in China, between 18 June 2020 to 8 January 2021.ParticipantsPeople with symptomatic dry eye disease aged 18-45 years with ocular surface disease index scores ranging from 18 to 80 and tear film break-up time of eight seconds or less.InterventionsParticipants were randomised 1:1 to receive laughter exercise or artificial tears (0.1% sodium hyaluronic acid eyedrop, control group) four times daily for eight weeks. The laughter exercise group viewed an instructional video and participants were requested to vocalise the phrases “Hee hee hee, hah hah hah, cheese cheese cheese, cheek cheek cheek, hah hah hah hah hah hah” 30 times per five minute session. Investigators assessing study outcomes were masked to group assignment but participants were unmasked for practical reasons.Main outcome measuresThe primary outcome was the mean change in the ocular surface disease index (0-100, higher scores indicating worse ocular surface discomfort) from baseline to eight weeks in the per protocol population. The non-inferiority margin was 6 points of this index score. Main secondary outcomes included the proportion of patients with a decrease from baseline in ocular surface disease index score of at least 10 points and changes in dry eye disease signs, for example, non-invasive tear break up time at eight weeks.Results299 participants (mean age 28.9 years; 74% female) were randomly assigned to receive laughter exercise (n=149) or 0.1% sodium hyaluronic acid (n=150). 283 (95%) completed the trial. The mean change in ocular surface disease index score at eight weeks was −10.5 points (95% confidence interval (CI) −13.1 to −7.82) in the laughter exercise group and −8.83 (−11.7 to −6.02) in the control group. The upper boundary of the CI for difference in change between groups was lower than the non-inferiority margin (mean difference −1.45 points (95% CI −5.08 to 2.19); P=0.43), supporting non-inferiority. Among secondary outcomes, the laughter exercise was better in improving non-invasive tear break up time (mean difference 2.30 seconds (95% CI 1.30 to 3.30), P<0.001); other secondary outcomes showed no significant difference. No adverse events were noted in either study group.ConclusionsThe laughter exercise was non-inferior to 0.1% sodium hyaluronic acid in relieving subjective symptoms in patients with dry eye disease with limited corneal staining over eight weeks intervention.Trial registrationClinicalTrials.gov NCT04421300.

To explore the effectiveness of family participatory clown therapy in venipuncture in hospitalized children. We recruited 104 children aged 3 to 6 years for a non-randomized controlled trial from March to December 2022. All participants required peripheral venepuncture infusions for treatment. The children were assigned to either the control group (n = 52) or the experimental group (n = 52).Standard care was utilized in the control group. In the experimental group, two clown nurses and a parent provided family participatory clown therapy for 35-45 minutes per child before, during, and after venipuncture. We assessed children's pain (FLACC and W-B FPS), anxiety (VAS-A), medical fear (CFS), crying incidence, compliance, parental anxiety (S-AI), and parental satisfaction. At venipuncture, the FLACC score was lower in the experimental group (4.46±2.053) compared to the control group (5.96±2.441), the W-B FPS score was also lower in the experimental group (4.96±2.392) than in the control group (6.35±2.266), with a statistically significant difference (P<0.05).The children in the experimental group had lower levels of anxiety, medical fear, crying, and parental anxiety than the control group. In addition, child compliance and parent satisfaction were higher in the experimental group than in the control group, with statistically significant differences (P<0.05). Family participatory clown therapy can reduce pain, anxiety, medical fear, and crying during venipuncture in children. It can also improve venipuncture compliance, reduce parental anxiety, and increase parental satisfaction.

Community-acquired pneumonia (CAP) is a leading cause of hospitalization in children. The hospitalization duration depends on factors as child’s well-being, vital signs, need for parenteral treatments, and development of complications. Medical clowns (MCs) are known to assist in reducing pain and alleviating anxiety and have been integrated into many aspects of hospital treatment routines. Our aim was to evaluate the effect of MC intervention on length of hospitalization in children admitted with CAP. A prospective quasi-randomized controlled trial allocated 51 children (2–18 years) hospitalized for CAP to receive standard care (control group, n  = 25) or standard care plus 15-minute MC visits twice daily during the first 48 h of hospitalization (intervention group, n  = 26). The primary outcome was hospitalization duration. Both groups were comparable in all demographic and clinical characteristics at admission with a mean age of 4.4 ± 3.6 years. The intervention group had significantly shorter duration of hospitalization (43.5 vs. 70 h, p  = 0.03) and IV antibiotic treatment duration (48 vs. 72 h, p  < 0.01) compared to controls. When comparing day 1 to day 2 in each group, significant decreases in respiratory rate, heart rate, white blood cell count, and absolute neutrophil count were noted in the study group. No significant differences were observed between the two groups in changes in patient well-being. The integration of MC into the pediatric CAP care-team reduced length of hospitalization and need for IV antibiotics. This can improve the quality of care as well as the burden and cost endured by hospitalization with CAP. Future larger studies are warranted to support these positive effects of MC. Trial registration ClinicalTrials.gov Identifier NCT06750029, 27/12/2024.

Background Clowning has been used in many hospitals, particularly for children. Studies suggest the effectiveness of this methodology, but more evidence is needed. The aim of this study was to evaluate the impact of a humour therapy intervention on biological markers, pain and anxiety levels in paediatric patients. Methods Three different clinical contexts were chosen to assess the effect of clowning interventions: patients who were subjected to venepuncture (group 1), patients undergoing general anesthesia for any cause (group 2)and patients hospitalized in the pediatric ward without distinction of their disease (group 3). Groups 1 and 2 were divided into control (C) and intervention (I) subgroups. A saliva sample was taken from all the children to measure oxytocin and cortisol levels by ELISAs. Validated scales and crying time were used to determine pain, stress, and anxiety levels. Children in group 3 were assessed before and after the intervention, employing the same methods. Results A total of 272 patients were included. The children in group 1 ( n  = 125) were 7.7 ± 3.2 years old, and 53.6% were females. 48% were in the I group, which showed decreased cortisol levels and increased oxytocin levels. The I group exhibited a decrease in perceived pain and crying time. The children in group 2 ( n  = 69) were aged 7.1 ± 3.5 years, and 36% were females. 51% were in the I group, which showed increased oxytocin levels and decreased cortisol levels, acute stress levels, perceived pain, and crying time. The children in group 3 ( n  = 78) were 8.6 ± 3.3 years old, and 54% of the children were females. There was an increase in oxytocin levels and a decrease in cortisol levels, stress levels and perceived pain following the intervention. Conclusions This study suggested that an intervention based on clowning is an effective strategy for decreasing pain, stress, and anxiety levels in paediatric patients in different clinical contexts. These findings support the implementation of humour therapy programs in paediatric units.

Background Humor trainings have positive effects on mental health and well-being. However, studies investigating the effects of humor trainings in clinical samples are still rare. This study investigated the efficacy and feasibility of a humor training for people suffering from depression, anxiety and adjustment disorders. Methods Based on a diagnostic interview (SCID I and II), 37 people were randomized into a training ( n  = 19) or wait list control group ( n  = 18) and completed questionnaires at pre, post, and 1 month follow-up. After the training group had completed its training and evaluation measures, the wait list control group received the training and the outcomes of the group were additionally evaluated (post2 and follow-up2). Results After training, improvements in humor-related outcomes were observed for the training group, but these were relativized when compared to the wait list control group. Secondary outcomes remained unaffected by the training. In addition, the training group reported interpersonal difficulties. Within-group analyses of the wait list control group after completion of their training showed effects on almost all primary and secondary outcomes and feedback indicated a better atmosphere. Conclusions In summary, the different outcomes of the two groups are surprising and can show potential moderators of efficacy, such as interpersonal and group-specific climate variables. Since moderators of humor trainings in clinical samples have not been investigated at all, future studies should consider integrating them into their design. Trial registration The study was retrospectively registered in the German Clinical Trials Register ( DRKS00012443 ) on May 16, 2017.

The aim of the study is to investigate if the presence of medical clowns during painful procedures in the emergency department (ED) affects children’s anxiety and pain. Forty children (4–11 years) admitted to the ED with the need of painful procedures were prospectively enrolled. They were randomly assigned to the clown group, where children interacted with clowns or to the control group in which they were entertained by parents and ED nurses. The children’s anxiety was assessed by the Children’s Anxiety and Pain Scales; pain was evaluated with the Numerical Rating Scale and Wong-Backer Scale, according to the children’s age. Staff and clown’s opinions were evaluated by means of dedicated questionnaires. Children’s anxiety levels in the clown group were significantly lower than those compared with the control group, while children’s pain levels did not change between the two groups. Conclusion : The presence of clowns in the ED before and during painful procedures was effective in reducing children’s anxiety. What is Known: • Anxiety and fear caused by medical procedures exacerbate children’s pain and may interfere with the procedure. • To reduce anxiety, fear, and pain and to facilitate patient’s evaluation, different non-pharmacological approaches have been proposed and positive effects of laughter and humor have been reported. What is New: • The presence of clowns in the waiting room and in the ED during medical evaluation and painful procedures helps to reduce children’s anxiety.

We investigated the impact of clown-care on pain in 45 children with cerebral palsy who underwent recurrent Botulinum-toxin injections (age 7.04± 4.68 years). Participants were randomized to receive either clown (n = 20) or standard (n = 25) -care. Pain Visual-Analogue-Scale (range 1-5) was reported before and after procedures. Pain assessment was lower for children undergoing Botulinum-toxin injections with clown-care (2.89± 1.36) compared to standard-care (3.85± 1.39; p = 0.036) even though pain anticipated prior to procedures was similar (~3). Children who underwent the first procedure with clown-care reported lower pain even after they crossed-over to the following procedure which was standard (p = 0.048). Carryover effect was more prominent in injection-naïve children (p = 0.019) and during multiple procedures (p = 0.009). Prior pain experience correlated with pain in subsequent procedures only when first experience was standard-care (p = 0.001). Clown-care alleviated pain sensation during Botulinum-toxin injections and initial clown-care experience reduced pain during subsequent injections even though clowns were not present. clinicaltrials.gov ID # NCT01377883.

We investigated the contribution of group therapy delivered by a medical clown to young children diagnosed with autism spectrum disorder (ASD). So far, scientific publications regarding medical clowning focus on general health advantages. The current study is the first controlled research examining the use of medical clowning in the therapy for children with ASD. Twenty-four children aged 2–6 years old with ASD enrolled in our special education intensive program were examined before and after group sessions with clown intervention (CI) and other intervention (OI). We tested stereotypic behaviors, verbal expression, play reciprocity, and social smiles. Data was collected during 12 weeks of intervention, and the trajectory of change was evaluated in addition to the pre-/post-intervention.Conclusion: improvement over time in all measures: Significant increase in word production, play reciprocity, and amount of social smiles during CI as compared with OI. We also found a reduction in frequency of stereotypic behaviors during and following CI as compared with before CI. These preliminary results indicate that medical clowning may be beneficial for young children with ASD, since it promotes communication and social reciprocity in a fun and lively interventional setting.What is Known:• Many therapies are used and proven as efficacious interventions for children with ASD.• So far, medical clowning was not tested as an intervention or therapy for ASD.What is New:• Medical clowning sessions with children with ASD elicited enhanced communication during the interventions as compared with other interventions.• Medical clowning sessions contributed to a decrease in frequency of stereotypic movements over time, in children with ASD.

BackgroundRecurrent gynecologic cancer patients experience symptoms that affect psychologic, emotional, social, and physical well-being. Chemotherapy can further exacerbate these symptoms. Poor mood, pain, and fatigue are linked and are detrimental to quality of life. Interventions targeting these symptoms may improve patient-reported outcomes and performance status.ObjectivesTo determine the ability of a humorous digital media attention diversion to improve symptom domains of positive and negative mood during chemotherapy for patients with recurrent gynecologic cancers.Study designThis randomized, crossover clinical trial enrolled women with recurrent gynecologic cancers. Subjects participated over three cycles of chemotherapy. The primary outcome was the change in mood on the validated Positive and Negative Affect Scale-Extended (PANAS-X) instrument, which measures positive and negative affect domains. All subjects completed the PANAS-X after receiving chemotherapy during cycle 1 on study. In atudy arm 1, subjects watched their choice of humorous movies on a digital media device while receiving chemotherapy during cycle 2 on study. They selected from non-humorous movies during cycle 3 on study. In arm 2, the order of movies was reversed. After each cycle, mood, fatigue, and other patient-reported outcomes were assessed for comparison with baseline measurements.ResultsThe target enrollment of 66 subjects was achieved. Subjects watched humorous content for an average of 96.0 min and non-humorous content for an average of 62.5 min. Negative mood improved after exposure to humorous (p=0.017) and non-humorous content (p=0.001). Patient-reported fear also improved after exposure to both humorous (p=0.038) and non-humorous content (p=0.002). Subjects reported higher use of affiliating and self-effacing humor types.ConclusionsOffering patients a choice of digital media during chemotherapy significantly improved negative mood and fear. This was seen with both humorous and non-humorous content. This low-cost and low-risk intervention should be implemented as an attention diversion to improve negative mood and fear for patients receiving chemotherapy.

One objective of this study was to assess the effects of laughter on the psychological, immunological and physiological systems of the body. Another objective was to introduce the Laughing Qigong Program (LQP), as a method of standardization for simulated laughter interventions. A randomized, prospective, experimental study of the LQP was conducted in a group of adolescents (n=67) in Taiwan. During study-hall sessions, experimental subjects (n=34) attended the LQP for eight-weeks. Simultaneously, control subjects (n=33) read or did their homework. All subjects were tested before and after the intervention on the following: Rosenberg Self-Esteem scale (RSE), Chinese Humor Scale (CHS) and Face Scale (FS) as psychological markers; saliva cortisol (CS) as an immunological marker; blood pressure (BP), heart rate (HR), and heart rate variability (HRV) as physiological markers of the body's response to stress. Mood states (FS) were measured before/after each LQP session. Mood states (p=.00) and humor (p=.004; p=.003) improved in the experimental group; no significant changes were found in the controls (p=69; p=60). The immunological marker of stress, cortisol levels, decreased significantly for those who participated in the LQP (p=.001), suggesting lower levels of stress after completion of the program. The LQP is a non-pharmacological and cost-effective means to help adolescents mitigate stresses in their everyday life.