1 127 137 A PILOT STUDY TO EVALUATE THE FEASIBILITY OF INDIVIDUALIZED YOGA FOR INPATIENT CHILDREN RECEIVING INTENSIVE CHEMOTHERAPY. BACKGROUND: FATIGUE IS AN IMPORTANT PROBLEM IN PAEDIATRIC CANCER PATIENTS AND YOGA MAY BE AN EFFECTIVE INTERVENTION. THE PRIMARY OBJECTIVE WAS TO DETERMINE THE FEASIBILITY OF INDIVIDUALIZED YOGA FOR HOSPITALIZED CHILDREN RECEIVING INTENSIVE CHEMOTHERAPY. METHODS: WE INCLUDED ENGLISH-SPEAKING CHILDREN AND ADOLESCENTS AGED 7-18 YEARS RECEIVING INTENSIVE CHEMOTHERAPY OR HAEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT). YOGA WAS CONDUCTED THREE TIMES WEEKLY FOR THREE WEEKS. THE PRIMARY OUTCOME WAS FEASIBILITY, DEFINED AS ABILITY TO DELIVER AT LEAST 60% OF PLANNED SESSIONS. SECONDARY OUTCOMES WERE PARENT-REPORTED PEDIATRIC QUALITY OF LIFE INVENTORY (PEDSQL) MULTIDIMENSIONAL FATIGUE SCALE, FATIGUE SCALE-PARENT, PEDSQL GENERIC CORE SCALES AND PEDSQL ACUTE CANCER MODULE. RESULTS: BETWEEN JANUARY AND OCTOBER 2013, 11 PATIENTS WERE ENROLLED. MEDIAN AGE WAS 14.0 (RANGE 7.7-16.4) YEARS AND 6 (55%) WERE BOYS. YOGA WAS FEASIBLE WITH 10/11 PARTICIPANTS MEETING THE THRESHOLD FOR FEASIBILITY. THE MEDIAN NUMBER OF YOGA SESSIONS WAS 9 (RANGE 3-13). NO ADVERSE EVENTS WERE ATTRIBUTED TO YOGA. MEAN+/-STANDARD DEVIATION FOR THE DAY 21 PROXY-REPORTED PEDSQL GENERAL FATIGUE SCORES WAS 55.6+/-15.5. QUALITATIVE COMMENTS SUGGESTED DESIGN CHANGES FOR FUTURE YOGA STUDIES. CONCLUSIONS: INDIVIDUALIZED YOGA IS FEASIBLE FOR INPATIENT CHILDREN RECEIVING INTENSIVE CHEMOTHERAPY. FUTURE WORK WILL INCLUDE DEVELOPMENT AND CONDUCT OF A RANDOMIZED TRIAL FOR FATIGUE AMELIORATION. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT02105389. 2015 2 70 62 A FEASIBILITY STUDY EXAMINING THE IMPACT OF YOGA ON PSYCHOSOCIAL HEALTH AND SYMPTOMS IN PEDIATRIC OUTPATIENTS RECEIVING CHEMOTHERAPY. PURPOSE: PEDIATRIC CANCER PATIENTS EXPERIENCE SYMPTOMS THAT NEGATIVELY IMPACT QUALITY OF LIFE; YOGA MAY BE AN EFFECTIVE INTERVENTION. THE PRIMARY OBJECTIVE WAS TO DETERMINE THE FEASIBILITY OF A 10-WEEK, WEEKLY INDIVIDUALIZED YOGA INTERVENTION FOR CHILDREN AND ADOLESCENTS RECEIVING OUTPATIENT CANCER THERAPY PRIMARILY DELIVERED REMOTELY USING SKYPE. SECONDARY OBJECTIVES WERE TO DESCRIBE DEPRESSION, ANXIETY, ANGER, FATIGUE, QUALITY OF LIFE, AND SYMPTOMS AT 5 AND 10 WEEKS AFTER ENROLLMENT. METHODS: WE INCLUDED ENGLISH-SPEAKING PATIENTS AGED 10 TO 18 YEARS RECEIVING OUTPATIENT CHEMOTHERAPY FOR CANCER. WEEKLY INDIVIDUALIZED YOGA SESSIONS WERE OFFERED FOR 10 WEEKS. WEEKS 1, 5, AND 10 WERE IN-HOSPITAL WHILE THE REMAINING SESSIONS WERE DELIVERED REMOTELY USING SKYPE. TWICE WEEKLY, HOMEWORK WAS ASSIGNED BETWEEN EACH SESSION. THE PRIMARY OUTCOME WAS FEASIBILITY, DEFINED AS 80% OF PARTICIPANTS COMPLETING AT LEAST 60% OF PLANNED IN-HOSPITAL OR REMOTE YOGA SESSIONS. RESULTS: BETWEEN MARCH AND NOVEMBER 2017, 10 PATIENTS WERE ENROLLED. TWO PATIENTS DISCONTINUED THE STUDY AFTER ONE AND TWO SESSIONS. ONLY SIX PARTICIPANTS ACHIEVED AT LEAST 60% OF PLANNED YOGA SESSIONS AND THUS, THE STUDY DID NOT MEET THE A PRIORI DEFINED FEASIBILITY THRESHOLD. AMONG ALL PARTICIPANTS, ONLY ONE HOMEWORK SESSION WAS PERFORMED. CONCLUSIONS: A 10-WEEK INDIVIDUALIZED IN-PERSON AND REMOTELY CONDUCTED YOGA INTERVENTION WAS NOT FEASIBLE IN CHILDREN RECEIVING CANCER TREATMENTS BECAUSE OF FAILURE TO ACHIEVE THE DESIRED FREQUENCY OF YOGA SESSIONS IN A SUFFICIENT NUMBER OF PARTICIPANTS. FUTURE RESEARCH SHOULD IDENTIFY APPROACHES TO IMPROVE COMPLIANCE WITH REMOTE YOGA SESSIONS AND HOME PRACTICE. TRIAL REGISTRATION: NCT03318068. 2019 3 1250 31 FEASIBILITY STUDY: THE EFFECT OF THERAPEUTIC YOGA ON QUALITY OF LIFE IN CHILDREN HOSPITALIZED WITH CANCER. PURPOSE: TO DESCRIBE THE EFFECT OF THERAPEUTIC YOGA ON CHILD AND PARENTAL REPORTS OF QUALITY OF LIFE IN CHILDREN HOSPITALIZED WITH ONCOLOGICAL DIAGNOSES. METHODS: SIX CHILDREN PARTICIPATED IN 5 YOGA SESSIONS OVER 2 MONTHS. THE PEDSQL 4.0 WAS ADMINISTERED TO EACH CHILD AND PARTICIPATING PARENT/CAREGIVERS AT BASELINE AND AFTER COMPLETION OF THE YOGA INTERVENTION. THE WILCOXON NONPARAMETRIC RANK TEST MEASURED INDIVIDUAL DIFFERENCES OVER TIME. RESULTS: STATISTICALLY SIGNIFICANT DIFFERENCES (P < .05) WERE FOUND IN CHILD PERCEPTION OF GROSS MOTOR FUNCTION. CONCLUSION: THESE FEASIBILITY STUDY DATA SUGGEST THAT THERAPEUTIC YOGA POSITIVELY AFFECTED CHILD PERCEPTION OF GROSS MOTOR FUNCTION MEASURED ON THE PEDSQL 4.0. FURTHER STUDIES ARE NEEDED, INCLUDING A RANDOMIZED CONTROL TRIAL AND WITH A LARGER NUMBER OF PARTICIPANTS, TO CLARIFY AND CONFIRM THE EFFECT OF THERAPEUTIC YOGA. 2011 4 1242 41 FEASIBILITY OF A YOGA INTERVENTION TO DECREASE PAIN IN OLDER WOMEN: A RANDOMIZED CONTROLLED PILOT STUDY. BACKGROUND: A SIGNIFICANT PROPORTION OF OLDER WOMEN SUFFER FROM CHRONIC PAIN, WHICH CAN DECREASE QUALITY OF LIFE. THE OBJECTIVE OF THIS PILOT RANDOMIZED STUDY WAS TO EVALUATE THE FEASIBILITY OF A FLOW-RESTORATIVE YOGA INTERVENTION DESIGNED TO DECREASE PAIN AND RELATED OUTCOMES AMONG WOMEN AGED 60 OR OLDER. METHODS: FLOW-RESTORATIVE YOGA CLASSES WERE HELD TWICE WEEKLY FOR 1 HOUR AND LED BY A CERTIFIED YOGA INSTRUCTOR. PARTICIPANTS RANDOMIZED TO THE INTERVENTION GROUP ATTENDED THE YOGA CLASSES FOR 12 WEEKS AND RECEIVED SUPPLEMENTAL MATERIALS FOR AT-HOME PRACTICE. THOSE RANDOMIZED TO THE CONTROL GROUP WERE ASKED TO MAINTAIN THEIR NORMAL DAILY ROUTINE. FEASIBILITY WAS EVALUATED USING RECRUITMENT AND RETENTION RATES, CLASS AND HOME PRACTICE ADHERENCE RATES, AND PARTICIPANT SATISFACTION SURVEYS. OUTCOME MEASURES (SELF-REPORTED PAIN, INFLAMMATORY MARKERS, FUNCTIONAL FITNESS, QUALITY OF LIFE, RESILIENCE, AND SELF-REPORTED PHYSICAL ACTIVITY) WERE ASSESSED AT BASELINE AND POST-INTERVENTION. PAIRED T-TESTS OR WILCOXON SIGNED-RANK TESTS WERE USED TO EXAMINE CHANGES IN OUTCOME MEASURES WITHIN TREATMENT GROUPS. RESULTS: THIRTY-EIGHT PARTICIPANTS WERE RECRUITED AND RANDOMIZED. PARTICIPANTS WERE PRIMARILY WHITE, COLLEGE-EDUCATED, AND HIGHER FUNCTIONING, DESPITE EXPERIENCING VARIOUS FORMS OF CHRONIC PAIN. ATTENDANCE AND RETENTION RATES WERE HIGH (91 AND 97%, RESPECTIVELY) AND THE MAJORITY OF PARTICIPANTS WERE SATISFIED WITH THE YOGA PROGRAM (89%) AND WOULD RECOMMEND IT TO OTHERS (87%). INTERVENTION PARTICIPANTS ALSO EXPERIENCED REDUCTIONS IN PAIN INTERFERENCE AND IMPROVEMENTS IN ENERGY AND SOCIAL FUNCTIONING. CONCLUSIONS: THIS PILOT STUDY PROVIDES ESSENTIAL DATA TO INFORM A FULL SCALE RANDOMIZED TRIAL OF FLOW-RESTORATIVE YOGA FOR OLDER WOMEN WITH CHRONIC PAIN. FUTURE STUDIES SHOULD EMPHASIZE STRATEGIES TO RECRUIT A MORE DIVERSE STUDY POPULATION, PARTICULARLY OLDER WOMEN AT HIGHER RISK OF DISABILITY AND FUNCTIONAL DECLINE. TRIAL REGISTRATION: CLINICALTRIALS.GOV , NCT03790098 . REGISTERED 31 DECEMBER 2018 - RETROSPECTIVELY REGISTERED. 2020 5 2579 37 YOGA FOR HEALTH-RELATED QUALITY OF LIFE IN ADULT CANCER: A RANDOMIZED CONTROLLED FEASIBILITY STUDY. AN INCREASE IN PATIENT-LED UPTAKE OF COMPLEMENTARY THERAPIES IN ADULT CANCER HAS LED TO A NEED FOR MORE RIGOROUS STUDY OF SUCH INTERVENTIONS AND THEIR OUTCOMES. THIS STUDY THEREFORE AIMED TO EVALUATE THE FEASIBILITY AND ACCEPTABILITY OF A YOGA INTERVENTION IN MEN AND WOMEN RECEIVING CONVENTIONAL TREATMENT FOR A CANCER DIAGNOSIS. PROSPECTIVE, MIXED METHODS FEASIBILITY TRIAL ALLOCATED PARTICIPANTS TO RECEIVE ONE OF THREE YOGA INTERVENTIONS OVER A FOUR-WEEK STUDY PERIOD. DATA COLLECTION WAS COMPLETED THROUGH ONLINE SURVEY OF QOL-CA/CS AND CUSTOMIZED SURVEYS. FIFTEEN PARTICIPANTS WERE INCLUDED (11 FEMALE) UNDERGOING TREATMENT FOR BREAST, PROSTATE, COLORECTAL, BRAIN, AND BLOOD AND LUNG CANCER. TWO PARTICIPANTS DROPPED OUT AND COMPLETE QUALITATIVE AND QUANTITATIVE DATA SETS WERE COLLECTED FROM 12 PARTICIPANTS AND FOUR YOGA INSTRUCTORS. OTHER OUTCOME MEASURES INCLUDED IMPLEMENTATION COSTS PATIENT-REPORTED PREFERENCES FOR YOGA INTERVENTION AND CHANGES IN QOL-CA/CS. THREE TYPES OF YOGA INTERVENTION WERE SAFELY ADMINISTERED IN ADULT CANCER. MIXED METHODS, COST-EFFICIENCY, QOL-CA/CS, AND EVIDENCE-BASED DESIGN OF YOGA INTERVENTION HAVE BEEN USED TO ESTABLISH FEASIBILITY AND PATIENT-PREFERENCES FOR YOGA DELIVERY IN ADULT CANER. RESULTS SUGGEST THAT, WITH SOME METHODOLOGICAL IMPROVEMENTS, A LARGE-SCALE RANDOMIZED CONTROLLED TRIAL IS WARRANTED TO TEST THE EFFICACY OF YOGA FOR MALE AND FEMALE CANCER PATIENTS. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV NCT02309112. 2015 6 206 32 A SELF-DIRECTED HOME YOGA PROGRAMME FOR WOMEN WITH BREAST CANCER DURING CHEMOTHERAPY: A FEASIBILITY STUDY. RECENT STUDIES SUGGEST YOGA AS A PROMISING APPROACH FOR IMPROVING THE COGNITIVE FUNCTION OF CANCER SURVIVORS. WE STUDIED WHETHER A SELF-DIRECTED HOME YOGA PROGRAMME WAS FEASIBLE FOR PATIENTS WITH BREAST CANCER WHO WERE UNDERGOING CHEMOTHERAPY. PARTICIPANTS' PREFERENCES FOR THE TYPE OF YOGA COURSE AND THE CLINICAL EFFECTS OF THE PROGRAMME WERE ALSO ASSESSED. IN THIS STUDY, 18 WOMEN (MEAN AGE, 43.9 YEARS) WERE ENROLLED (44.7% RECRUITMENT RATE). OF THE PARTICIPANTS, 63.6% HAD STAGE II CANCER AND 71.4% RECEIVED ADJUVANT CHEMOTHERAPY. FAVOURABLE RETENTION (86%), ADHERENCE (94.4%) AND ACCEPTABILITY (96.5%) RATES WERE DETERMINED. MOST (94.4%) OF THE WOMEN PRACTICED THE HOME PROGRAMME MORE THAN TWICE A WEEK ON AVERAGE. THE PARTICIPANTS PREFERRED TO GRADUALLY INCREASE THE INTENSITY OF THE EXERCISES. WE ONLY OBSERVED IMPROVEMENTS IN THE COGNITIVE ASPECTS OF FATIGUE. NO SERIOUS ADVERSE EVENTS WERE ENCOUNTERED DURING THE PROGRAMME. THIS SELF-DIRECTED HOME YOGA PROGRAMME WAS SAFE AND FEASIBLE FOR PATIENTS WITH BREAST CANCER UNDERGOING CHEMOTHERAPY. 2016 7 446 54 CHALLENGES OF IMPLEMENTING MULTICENTER STUDIES OF YOGA FOR PEDIATRIC CANCER AND HEMATOPOIETIC STEM CELL TRANSPLANTATION RECIPIENTS. THE PRIMARY OBJECTIVE OF THIS WORK WAS TO DETERMINE THE FEASIBILITY OF A RANDOMIZED TRIAL OF INDIVIDUALIZED YOGA FOR CHILDREN RECEIVING INTENSIVE CHEMOTHERAPY AND FOR HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) RECIPIENTS OUTSIDE OF THE PRINCIPAL COORDINATING INSTITUTION. WE EVALUATED THE FEASIBILITY OF A RANDOMIZED TRIAL OF INDIVIDUALIZED YOGA VERSUS AN IPAD CONTROL PROGRAM AT A SITE WHERE EXTERNAL YOGA INSTRUCTORS WERE HIRED AND COMPENSATED PER SESSION. SUBJECTS WERE CHILDREN RECEIVING INTENSIVE CHEMOTHERAPY FOR HEMATOLOGICAL MALIGNANCIES AND AUTOLOGOUS OR ALLOGENEIC HSCT RECIPIENTS EXPECTED TO BE HOSPITALIZED FOR 3 WEEKS. YOGA OR IPAD CONTROL CONTACT OCCURRED DAILY FOR 21 DAYS (EXCLUDING WEEKENDS AND HOLIDAYS); FATIGUE AND QUALITY-OF-LIFE OUTCOMES WERE MEASURED AT BASELINE, DAY 10, AND DAY 21. TEN ELIGIBLE SUBJECTS WERE IDENTIFIED; SIX SUBJECTS CONSENTED AND WERE ENROLLED. THREE WERE RANDOMIZED TO THE INDIVIDUALIZED YOGA INTERVENTION AND THREE TO THE IPAD CONTROL PROGRAM. THE MEDIAN AGE OF PARTICIPANTS WAS 12 (RANGE 8-15) YEARS, AND 2 (33%) WERE BOYS. CHALLENGES PRIMARILY RELATED TO THE HIRING OF YOGA INSTRUCTORS WHO WERE NOT TRAINED IN RESEARCH METHODS. WE FOUND ISSUES WITH: (1) LOGISTICS OF HIRING, TRAINING, AND RETAINING INSTRUCTORS; (2) COMMUNICATION BETWEEN TEAMS; (3) FIDELITY TO THE PROTOCOL AND OUTCOME ASSESSMENTS; AND (4) ENSURING SAFETY. WE FOUND THAT A RANDOMIZED TRIAL OF INDIVIDUALIZED YOGA PRESENTED NEW CHALLENGES WHEN RELYING ON EXTERNALLY CONTRACTED YOGA INSTRUCTORS. FUTURE MULTICENTER STUDIES OF YOGA SHOULD SEEK TO BETTER INTEGRATE PRACTITIONERS WITHIN THE RESEARCH TEAM TO IMPROVE PROCESSES, COMMUNICATION, FIDELITY TO THE PROTOCOL, AND SAFETY. 2021 8 1233 39 FEASIBILITY AND PRELIMINARY EFFICACY OF TAILORED YOGA IN SURVIVORS OF HEAD AND NECK CANCER: A PILOT STUDY. PURPOSE: TREATMENT FOR HEAD AND NECK CANCER (HNC) RESULTS IN LONG-TERM TOXICITIES AND INCREASED PHYSICAL AND PSYCHOSOCIAL SURVIVOR BURDEN. THERE ARE A LIMITED NUMBER OF TREATMENTS FOR THESE LATE EFFECTS. YOGA POSTURES, BREATH WORK, RELAXATION, AND MEDITATION, MAY IMPROVE THESE LATE EFFECTS. THE PURPOSE OF THIS STUDY WAS TO EXAMINE THE FEASIBILITY OF A TAILORED YOGA PROGRAM IN HNC SURVIVORS AND OBTAIN PRELIMINARY EFFICACY DATA. METHODS: THIS WAS A RANDOMIZED WAIT-LIST CONTROL STUDY OF YOGA-NAIVE HNC SURVIVORS WHO WERE >3 MONTHS POST-CANCER TREATMENT. BASELINE DATA WERE COLLECTED. PARTICIPANTS WERE RANDOMIZED TO EITHER AN 8-WEEK HATHA YOGA INTERVENTION GROUP OR A WAIT-LIST GROUP. FEASIBILITY AND EFFICACY DATA WERE COLLECTED. AT 4 AND 8 WEEKS, PATIENTS UNDERWENT A REPEAT ASSESSMENT OF HEALTH. WAIT-LIST CONTROL GROUP PARTICIPANTS WERE OFFERED THE YOGA PROGRAM AFTER DATA COLLECTION. DESCRIPTIVE STATISTICS EVALUATED FEASIBILITY. MIXED EFFECTS GENERAL LINEAR MODELS WERE USED TO GENERATE ESTIMATES OF THE EFFICACY OUTCOMES. RESULTS: SEVENTY-THREE INDIVIDUALS WERE SCREENED AND 40 WERE ELIGIBLE. ALL ELIGIBLE INDIVIDUALS CONSENTED AND ENROLLED. FIVE OF THE INTERVENTION GROUP DISCONTINUED EARLY AND NONE IN THE WAIT-LIST CONTROL GROUP. FEASIBILITY WAS AFFIRMED AS PARTICIPANTS WERE RECRUITED AND RETAINED IN THE STUDY, THERE WERE NO ADVERSE EVENTS, FIDELITY TO PROTOCOL WAS DEMONSTRATED, AND SATISFACTION RATES WERE HIGH. EFFICACY MEASURES INDICATED POTENTIAL BENEFIT FOR SHOULDER RANGE OF MOTION ( D = 0.57-0.86, P < .05), PAIN ( D = 0.67-0.90, P .05) OR ANXIETY (F = 2.7, P > .05). CONCLUSIONS/IMPLICATIONS FOR PRACTICE: THE 8-WEEK YOGA EXERCISE PROGRAM DEVELOPED IN THIS STUDY EFFECTIVELY REDUCED FATIGUE IN PATIENTS WITH BREAST CANCER BUT DID NOT REDUCE DEPRESSION OR ANXIETY. ONCOLOGY NURSES SHOULD STRENGTHEN THEIR CLINICAL HEALTH EDUCATION AND APPLY YOGA TO REDUCE THE FATIGUE EXPERIENCED BY PATIENTS WITH BREAST CANCER WHO UNDERGO ADJUVANT CHEMOTHERAPY. 2014 18 2605 34 YOGA FOR PERSISTENT FATIGUE IN BREAST CANCER SURVIVORS: RESULTS OF A PILOT STUDY. APPROXIMATELY ONE-THIRD OF BREAST CANCER SURVIVORS EXPERIENCES PERSISTENT FATIGUE FOR MONTHS OR YEARS AFTER SUCCESSFUL TREATMENT COMPLETION. THERE IS A LACK OF EVIDENCE-BASED TREATMENTS FOR CANCER-RELATED FATIGUE, PARTICULARLY AMONG CANCER SURVIVORS. THIS SINGLE-ARM PILOT STUDY EVALUATED THE FEASIBILITY AND PRELIMINARY EFFICACY OF A YOGA INTERVENTION FOR FATIGUED BREAST CANCER SURVIVORS BASED ON THE IYENGAR TRADITION. IYENGAR YOGA PRESCRIBES SPECIFIC POSES FOR INDIVIDUALS WITH SPECIFIC MEDICAL PROBLEMS AND CONDITIONS; THIS TRIAL EMPHASIZED POSTURES BELIEVED TO BE EFFECTIVE FOR REDUCING FATIGUE AMONG BREAST CANCER SURVIVORS, INCLUDING INVERSIONS AND BACKBENDS PERFORMED WITH THE SUPPORT OF PROPS. TWELVE WOMEN WERE ENROLLED IN THE TRIAL, AND 11 COMPLETED THE FULL 12-WEEK COURSE OF TREATMENT. THERE WAS A SIGNIFICANT IMPROVEMENT IN FATIGUE SCORES FROM PRE- TO POST-INTERVENTION THAT WAS MAINTAINED AT THE 3-MONTH POST-INTERVENTION FOLLOWUP. SIGNIFICANT IMPROVEMENTS WERE ALSO OBSERVED IN MEASURES OF PHYSICAL FUNCTION, DEPRESSED MOOD, AND QUALITY OF LIFE. THESE RESULTS SUPPORT THE ACCEPTABILITY OF THIS INTERVENTION AND SUGGEST THAT IT MAY HAVE BENEFICIAL EFFECTS ON PERSISTENT POST-TREATMENT FATIGUE. HOWEVER, RESULTS REQUIRE REPLICATION IN A LARGER RANDOMIZED CONTROLLED TRIAL. 2011 19 119 41 A PILOT STUDY OF THE ACCEPTABILITY, FEASIBILITY AND SAFETY OF YOGA FOR CHRONIC PAIN IN SICKLE CELL DISEASE. OBJECTIVES: TO DETERMINE THE ACCEPTABILITY, FEASIBILITY AND SAFETY OF YOGA FOR CHRONIC PAIN IN SICKLE CELL DISEASE. DESIGN AND SETTING: IN PART A OF THIS TWO-PART STUDY, ADOLESCENTS WITH SCD AND CHRONIC PAIN (GROUP 1) AND THEIR PARENT (GROUP 2) COMPLETED A SURVEY DESIGNED TO CAPTURE PAIN CHARACTERISTICS, ATTITUDES AND PRACTICES RELATED TO YOGA, AND POTENTIAL ACCEPTABILITY OF A YOGA PROGRAM. IN PART B, THE STUDY ASSESSED THE FEASIBILITY AND SAFETY OF AN INSTRUCTOR-LED GROUP YOGA PROGRAM. THE STUDY WAS REGISTERED ON CLINICALTRIALS.GOV (NCT03694548). INTERVENTION: EIGHT INSTRUCTOR-LED GROUP YOGA SESSIONS. MAIN OUTCOME MEASURES: FEASIBILITY AND SAFETY OUTCOMES WERE CHOSEN A PRIORI, AS FOLLOWS: 1) PROPORTION OF ADOLESCENT PATIENTS WITH SCD AND CHRONIC PAIN APPROACHED THAT CONSENT TO PARTICIPATE IN PART A, 2) PROPORTION OF ADOLESCENT PARTICIPANTS ENROLLED IN PART A THAT CONSENT TO PARTICIPATE IN PART B, 3) PROPORTION OF PARTICIPANTS ENROLLED IN PART B THAT ATTEND AT LEAST 6 OF 8 YOGA SESSIONS, 4) PROPORTION OF PARTICIPANTS ENROLLED IN PART B WITH AN ED VISIT OR A HOSPITALIZATION FOR PAIN WITHIN 24 H OF COMPLETION OF EACH YOGA SESSION, 5) PROPORTION OF PARTICIPANTS IN PART B WHO COMPLETE ALL STUDY ASSESSMENTS BEFORE, AND AT THE END OF THE YOGA PROGRAM, 6) ADHERENCE TO SUBMISSION OF PAIN DIARY. RESULTS: THE MEDIAN AGE OF 15 PATIENT PARTICIPANTS IN PART A WAS 16 (IQR 14-17), AND 14 PARENTS WAS 43.5 (IQR 42-51). MOST PARTICIPANTS WERE FEMALE. MOST PARTICIPANT RESPONSES INDICATED A POSITIVE OPINION OF YOGA. NINE ADOLESCENTS (60 %) FROM PART A PARTICIPATED IN PART B OF THE STUDY. THE MEDIAN AGE OF 9 PARTICIPANTS IN PART B WAS 17 (IQR 15-18), AND 5 OF THE 9 PARTICIPANTS WERE FEMALE (53.3 %). ONLY ONE PARTICIPANT WAS ABLE TO ATTEND 3 OF THE 8 YOGA SESSIONS OFFERED, AND DID NOT EXPERIENCE ANY ED VISITS OR HOSPITALIZATIONS FOLLOWING THE YOGA SESSIONS. NONE OF THE OTHER FEASIBILITY ENDPOINTS WERE MET IN THIS STUDY. CONCLUSIONS: PATIENTS WITH SCD AND CHRONIC PAIN OVERALL HAVE A POSITIVE OPINION OF YOGA, BUT THERE ARE CHALLENGES WITH RECRUITMENT AND RETENTION OF PARTICIPANTS IN A CLINICAL TRIAL OF YOGA, AND BARRIERS TO FEASIBILITY OF AN IN-PERSON GROUP YOGA INTERVENTION. 2021 20 2187 43 THE EFFECTS OF YOGA ON STUDENT MENTAL HEALTH: A RANDOMISED CONTROLLED TRIAL. BACKGROUND: UNIVERSITIES AROUND THE WORLD ARE FACING AN EPIDEMIC OF MENTAL DISTRESS AMONG THEIR STUDENTS. THE PROBLEM IS TRULY A PUBLIC HEALTH ISSUE, AFFECTING MANY AND WITH SERIOUS CONSEQUENCES. THE GLOBAL BURDEN OF DISEASE-AGENDA CALLS FOR EFFECTIVE INTERVENTIONS WITH LASTING EFFECTS THAT HAVE THE POTENTIAL TO IMPROVE THE MENTAL HEALTH OF YOUNG ADULTS. IN THIS STUDY WE AIMED TO DETERMINE WHETHER YOGA, A POPULAR AND WIDELY AVAILABLE MIND-BODY PRACTICE, CAN IMPROVE STUDENT MENTAL HEALTH. METHODS: WE PERFORMED A RANDOMISED CONTROLLED TRIAL WITH 202 HEALTHY UNIVERSITY STUDENTS IN THE OSLO AREA. THE PARTICIPANTS WERE ASSIGNED TO A YOGA GROUP OR WAITLIST CONTROL GROUP IN A 1:1 RATIO BY A SIMPLE ONLINE RANDOMISATION PROGRAM. THE INTERVENTION GROUP WAS OFFERED 24 YOGA SESSIONS OVER 12 WEEKS. MEASUREMENTS WERE TAKEN AT WEEK 0 (BASELINE), WEEK 12 (POST-INTERVENTION), AND WEEK 24 (FOLLOW-UP). THE PRIMARY OUTCOME WAS PSYCHOLOGICAL DISTRESS ASSESSED BY THE HSCL-25 QUESTIONNAIRE. ANALYSIS WAS PERFORMED BASED ON THE INTENTION TO TREAT-PRINCIPLE. RESULTS: BETWEEN 24 JANUARY 2017, AND 27 AUGUST 2017, WE RANDOMLY ASSIGNED 202 STUDENTS TO A YOGA INTERVENTION GROUP (N = 100), OR WAITLIST CONTROL GROUP (N = 102). COMPARED WITH THE CONTROL GROUP, THE YOGA PARTICIPANTS DEMONSTRATED A SIGNIFICANT REDUCTION IN DISTRESS SYMPTOMS BOTH AT POST-INTERVENTION (ADJUSTED DIFFERENCE IN THE MEAN CHANGE -0.15, 95% CI -0.26 TO -0.03, P = 0.0110) AND FOLLOW-UP (ADJUSTED DIFFERENCE IN THE MEAN CHANGE -0.18, 95% CI -0.29 TO -0.06, P = 0.0025). SLEEP QUALITY ALSO IMPROVED AT POST-INTERVENTION AND FOLLOW-UP. NO ADVERSE EVENTS WERE REPORTED. CONCLUSIONS: OUR FINDINGS SUGGEST THAT YOGA HAS A MODERATELY LARGE AND LASTING EFFECT, AT LEAST FOR SOME MONTHS, REDUCING SYMPTOMS OF DISTRESS AND IMPROVING SLEEP QUALITY AMONG STUDENTS. FURTHER RESEARCH SHOULD SEEK WAYS TO ENHANCE THE EFFECT, ASSESS AN EVEN LONGER FOLLOW-UP PERIOD, INCLUDE ACTIVE CONTROL GROUPS, AND CONSIDER PERFORMING SIMILAR STUDIES IN OTHER CULTURAL SETTINGS.TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT04258540. 2020