| ObjectiveThis study focuses on elderly patients with insomnia of liver and kidney Yin deficiency syndrome.Under the guidance of the classic theory of five viscera generating five spirits and considering the etiology and pathogenesis of elderly insomnia with liver and kidney yin deficiency syndrome,differentiation chose Yu-tone and Jue-tone music which corresponding to the kidney and liver for intervention.And also combines the inner connection between sound and color confirmed by psychophysics theories and the relationship among five elements,five viscera,fivetone,five-color on music intervention.It is hoped that by adjusting the different colors of music intervention ambient light,to explore the intervention effect of music therapy based on five-tone corresponding to five-color in improving sleep quality,daytime fatigue,traditional Chinese medicine(TCM)syndrome,negative emotions and quality of life in elderly insomnia patients with Yin deficiency syndrome of liver and kidney.This study further explains the scientific nature of the five-element music therapy guided by the classic theory of five viscera generating five spirits from the theoretical and empirical perspectives.Standardize and enrich the operation process of fiveelement music therapy;to explore the effectiveness and superiority of music therapy based on five-tone and five-color;in order to lay a foundation for the popularization and promotion of the music therapy based on five-tone corresponding to five-color.MethodsThe research was designed as randomized controlled trial.Before the formal trial,according to the domestic and foreign literature review and the opinions of teachers of Chinese medicine and music practitioners,the intervention plan of the study was rationally designed from the selection of music and implementation process of the fiveelement music therapy.From July 2020 to January 2021,84 elderly insomnia patients with liver and kidney yin deficiency syndrome who met the inclusion and exclusion criteria were collected from two elderly care institutions in Ziyang City,Sichuan Province.Used the random serial number generated by SPSS 21.0 statistical software to randomly group the patients,put the random allocation card(84 random serial numbers and groups)into the corresponding air-tight,opaque envelope,and the other person will not participate in the third-party storage of the trial process,and blindly blind the data collectors.The eligible research subjects opened the corresponding numbered envelopes in the order of entry,and randomly assigned 42 cases to the experimental group(the music therapy based on five-tone and five-color group)and the control group(the five-element music therapy group)according to the content of the random allocation card in the envelope.Both groups of patients were given 4 weeks of sleep hygiene health education as a basic intervention,including individual guidance and concentrated lectures.Individual guidance is one-to-one,face-to-face guidance,once every 2 weeks,20~30min each time,2 times in total;concentrated lectures are divided into 2 topics,namely senile insomnia related knowledge and sleep hygiene health education,once every 2 weeks,30~40min each time,2 times in total.On this basis,the experimental group used the Yu-tone and the Jue-tone five-element therapy based on the five-tone and the five-color to intervene [corresponding zang-fu selected music + listen to the Yu-tone music by adjust the environment to dark(color temperature to 2700 K,illuminance to 5lux;when listening to Jue-tone music by adjust to green light environment(light wavelength is 535nm~568nm,illuminance to 15lux)].the control group used the Yu-tone and the Jue-tone(corresponding to the zang-fu organs to choose music)five-element therapy for intervention.Both two groups of patients received music intervention once a day,each intervention for 30 minutes,continuous intervention for 5 days a week,2 weeks as a course of treatment,a total of2 courses of intervention.The Pittsburgh Sleep Quality Index(PSQI),Insomnia Severity Index(ISI),Flinders Fatigue Scale(FFS),Self-rating Anxiety scale(SAS),Self-rating Depression Scale(SDS)were used to evaluate the sleep quality,daytime fatigue and the negative emotions of the participants before intervention,at the second and fourth weekend of intervention.TCM syndrome score scale of liver and kidney Yin deficiency and The Short Form-36 Health Survey(SF-36)were used to evaluate the TCM syndrome and quality of life of the patients.At the fouth weekend of intervention,nimodipine method was used to calculate the reduction rate of PSQI score and liver and kidney Yin deficiency syndrome scores of patients in the two groups,the clinical efficacy of this study was evaluated according to the clinical efficacy criteria in Guiding Principles for Clinical Research of New Chinese Medicine.ResultsIn the study,a total of 81 elderly patients with insomnia completed data collection and were included in the final statistical analysis.Among them,there were 40 cases in the experimental group(2 cases dropped)and 41 cases in the control group(1 case dropped).There were comparable of the baseline data of the two groups before intervention.And the specific analysis results after intervention were as follows:1.Evaluation results of sleep quality(1)Comparison of PSQI scores1)The results of comparison between groups showed that: at the end of the second,fourth weekend of intervention,there were statistically significant differences in the total score of PSQI and the score of the dimensions of sleep quality,sleep time,sleep efficiency and daytime dysfunction between the experimental group and the control group(P<0.05).2)The results of repeated measure ANOVA showed that: The total score of PSQI and the score of subjective sleep quality dimension,time to fall asleep dimension and daytime dysfunction score of experimental group and control group had statistical significance in time effect,inter-group effect and interaction effect(P<0.05).The scores of PSQI sleep time dimension,sleep efficiency dimension,sleep disorder dimension and hypnotic drug dimension in two groups had statistical significance in time effect(P<0.05).The score of PSQI sleep efficiency dimension in both group patients had statistical significance in the inter-group effect(P<0.05).3)The pairwise comparison results of PSQI at each time point in the two groups showed that: the scores of PSQI subjective sleep quality dimension,sleep time dimension,sleep time dimension,sleep efficiency dimension,sleep disorder dimension,daytime dysfunction dimension and total score in the experimental group before intervention,at the second weekend of intervention and at the fourth weekend of intervention were all lower than those in the former time point,with statistical significance(P<0.05).The score of PSQI hypnotic drug dimension in the experimental group at the second and fourth weekend of intervention were lower than those before intervention,with statistical significance(P<0.05).The scores of PSQI subjective sleep quality,sleep time,sleep time,sleep efficiency,sleep disorder and daytime dysfunction in the control group before intervention,at the second weekend of intervention and at the fourth weekend of intervention were all lower than those in the previous time point,with statistical significance(P<0.05).The score of hypnotic drug dimension in control group at the fourth weekend of intervention was lower than that before intervention,the difference was statistically significant(P<0.05).The total PSQI scores of the control group at the second and fourth weekend of intervention were lower than those before intervention,and the difference was statistically significant(P<0.05).(2)Comparison of ISI scores1)The results of comparison between groups showed that: at the second weekend of intervention and the fourth weekend of intervention,the ISI scores in the experimental group compared with the control group were statistically significant(P<0.05).2)The results of repeated measure ANOVA showed that: the ISI scores of the experimental group and the control group were statistically significant in time effect,inter-group effect,time and inter-group interaction(P<0.05).3)The pairwise comparison results of ISI at each time point in the two groups showed that: before intervention,at the second weekend of intervention and the fourth weekend of intervention,the ISI scores at the later time point in the two groups were all lower than those at the previous time point,with statistical significance(P<0.05).2.Evaluation of daytime fatigue degree(1)The results of comparison between groups showed that: there was statistically significant difference in FFS scores between the two groups at the second and fourth weekend of intervention(P<0.05).(2)The results of repeated measure ANOVA showed that: there were significant differences in FFS scores in time effect,inter-group effect and interaction effect between the two groups(P<0.05).(3)The pairwise comparison results of FFS at each time point in the two groups showed that: the FFS scores at the later time point of the two groups were all lower than those at the previous time point,with statistical significance(P<0.05).3.Evaluation of TCM syndromes(1)The results of comparison between groups showed that: at the fourth weekend of the intervention,there was a statistically significant difference between the TCM liver and kidney yin deficiency syndrome scores of the experimental group and the control group(P<0.05).(2)The results of intra-group comparison showed that: there were statistically significant differences in TCM syndrome scores of the experimental group and the control group before intervention and at the fourth weekend of the intervention(P<0.05).4.Evaluation results of negative emotions(1)Comparison of SAS scores1)The results of comparison between groups showed that: there were statistically significant differences in SAS scores between the two groups at the second and fourth weekend of intervention(P<0.05).2)The results of repeated measure ANOVA showed that: SAS scores in the two groups had statistical significance in time effect,inter-group effect and interaction effect(P<0.05).(3)The pairwise comparison results of SAS at each time point in the two groups showed that: SAS scores at the later time point in the two groups were lower than those at the previous time point,with statistical significance(P<0.05).(2)Comparison of SDS scores1)The results of comparison between groups showed that: there was a significant difference in SDS scores between the two groups at the end of the fourth weekend of intervention(P<0.05).2)The results of repeated measure ANOVA showed that: SDS scores of the two groups had statistical significance in time effect and interaction effect(P<0.05),but had no statistical significance in intergroup effect(P>0.05).3)The pairwise comparison results of SDS at each time point in the two groups showed that:SDS scores at the later time point in the two groups were lower than those at the previous time point,with statistical significance(P<0.05).5.Quality of life evaluation results(1)The results of comparison between groups showed that: at the end of the fourth weekend intervention,there were statistically significant differences between the two groups in the dimensions of SF-36 energy and mental health(P<0.05).But there were no statistically significant differences in the dimensions of physiological function,physiological function,body pain,general health condition,social function and emotional function(P<0.05).(2)The results of intra-group comparison showed that:before intervention and at the end of fourth weekend intervention,excepting the dimension of physiological function,comparison of scores within the group were without statistically significant differences in the rest of 7 dimensions(physiological function,physical pain,general health status,energy,social function,mental health,emotional function).However,there was no statistically significant difference between the two groups in the SF-36 physiological function dimension within the group comparison(P<0.05).6.Efficacy evaluation resultsNimodipine method was used to calculate the PQI score and TCM liver and kidney Yin deficiency syndrome score reduction rate of the experimental group and the control group after intervention.And the efficacy of the two groups were determined according to the Guiding Principles for Clinical Research of New Chinese Medicine.(1)The clinical efficacy evaluation results of PSQI showed that: in the experimental group,0 cases were cured,6 cases were significantly effective,26 cases were effective and 8 cases were ineffective,and the total effective rate was 80%.In the control group,0 cases were cured,1 case showed obvious effect,24 cases were effective,16 cases were ineffective,and the total effective rate was 60.9%.(2)The clinical efficacy evaluation results of TCM syndrome showed that: in the experimental group,0 cases were cured,2 cases showed obvious effect,29 cases were effective,9 cases were ineffective,and the total effective rate was 77.5%.In the control group,0 cases were cured,0 cases showed obvious effect,24 cases were effective,17 cases were ineffective,and the total effective rate was 55.8%.After intervention,the total effective rates of PSQI and liver and kidney Yin deficiency syndrome in experimental group were higher than those in control group,with statistical significance(P<0.05).ConclusionsGuided by the theory of five viscera generating five spirits and treated by the harmonization of liver and kidney,the music therapy based on five-tone corresponding to five-color could improve patients’ sleep quality,daytime fatigue,TCM syndrome,negative emotions and quality of life,and its efficacy is better than that of conventional five-element music therapy,furthermore,the efficacy is better with the extension of intervention time.Based on the correspondence relationship between five-tone and five-color,applying the five-color of Chinese medicine to the implementation process of five-element music therapy to further enrich the implementation process of the fiveelement music therapy,and promote the development of the effectology of traditional Chinese medicine five-element music therapy,which is worthy of further application and promotion in clinical practice. |