[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659128":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":28,"studyPopulation":21,"armGroups":29,"interventions":41,"overallOfficials":21,"centralContacts":50,"locations":56,"responsibleParty":81,"collaborators":83,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":21,"enrollmentInfo":96,"targetDuration":21,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":58,"whyStopped":21,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Institut Rafael","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Pain and quality of life","Change in pain and functional quality of life assessed between baseline (Day 0) and 6 weeks using the Brief Pain Inventory (BPI). • Calculation: The mean (average) of four items measuring pain in the last 24 hours or past week: worst pain, least pain, average pain, and current pain (\"pain right now\"). (Alternatively, a single item like \"worst pain\" can be evaluated on its own).\n\n• Scale Range: 0 to 10 (0 = \"no pain\", 10 = \"pain as bad as you could imagine\"). Cut-offs: 0 - 3: Mild pain, 4 - 6: Moderate pain, 7 - 10: Severe pain","6 weeks",[14,17],{"measure":15,"description":16,"timeFrame":12},"Emotional distress variation","Change in emotional distress assessed at baseline, 6 weeks, and 1 month using the K10 psychological distress questionnaire (Kessler). Questions: 10 items.\n\nScale: Each item is rated on a 5-point Likert scale from 1 (none of the time) to 5 (all of the time). Total Score Range: 10 to 50 (calculated by summing all 10 responses).\n\n.Results 10 - 15 (Low \u002F Well): Little to no psychological distress; likely within normal limits. 16 - 21 (Moderate Distress): Mild to moderate levels of emotional strain or symptoms. 22 - 29 (High Distress): High level of psychological distress; may indicate a mild-to-moderate mental health disorder requiring attention or early intervention; 30 - 50 (Very High \u002F Severe Distress): Severe psychological distress; strongly indicates a probable serious mental health condition and a need for professional evaluation or specialist referral.",{"measure":18,"description":19,"timeFrame":20},"Patient's experience","Semi-structured qualitative questionnaire on the experience and perception of the combined treatment, administered one month after the final session","1 month after final intervention",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":27,"maskingDescription":21,"whoMasked":21},"NONE","While increasingly effective, cancer treatments are often accompanied by severe side effects, including chronic pain, fatigue, and reduced quality of life. Pain has often a strong emotional component, influenced by anxiety, stress, or the psychological distress inherent in the treatment journey.\n\nOsteopathy is recognized as a beneficial complementary approach for cancer patients. By addressing tissue mobility, circulation, and muscle tension, it helps improve physical comfort, reduce musculoskeletal pain, and foster better functional recovery. Several studies have shown that osteopathy can help reduce pain intensity and improve the quality of life for patients undergoing cancer treatment.\n\nHowever, pain with a strong emotional component may require a more holistic approach; osteopathy offers gradual benefits that can be optimized by combining it with other complementary therapies, such as hypnosis.\n\nAs a complementary therapy, hypnosis is increasingly used for pain and stress management in oncology. It works by modulating pain perception and reducing anxiety, thereby helping patients cope better with their symptoms.\n\nCombining hypnosis with osteopathy could thus optimize treatment outcomes by integrating a holistic approach that addresses both physical and psychological needs. The aim of this study is to evaluate the impact of combined osteopathy and hypnosis treatment compared to osteopathic treatment alone in cancer patients, particularly regarding pain with a strong emotional component. This combined approach could represent a significant step forward in improving the well-being of oncology patients by offering care that is better suited to the multidimensional nature of pain.\n\nThis research combining osteopathy and hypnosis could help improve symptoms and quality of life of cancer patients, particularly those suffering from chronic pain, anxiety, fatigue, sleep disturbances, or impaired overall well-being.\n\nThe hypothesis is based on available data suggesting that the potential value of osteopathy in managing pain and functional disorders, and the patient's bodily experience and the value of hypnosis in managing anxiety and certain symptoms associated with cancer or its treatments.\n\nCombining these two interventions could allow for a complementary approach addressing the physical, emotional, and cognitive dimensions of the patient's experience. Osteopathy could promote improved mobility, reduced tension, and better body awareness, while hypnosis could help modulate pain perception, reduce anxiety, and strengthen the patient's coping mechanisms regarding the disease and treatments.\n\nConsequently, patients receiving this combined care are expected to show improvements in certain quality-of-life parameters, a reduction in pain intensity or impact, decreased stress or anxiety, and enhanced overall well-being. This study will explore these effects in a population of cancer patients while documenting the feasibility, acceptability, and perceived clinical value of this integrative intervention.",[30,35],{"label":31,"type":6,"description":32,"interventionNames":33},"Osteopathy","Patients assigned to this group will benefit from osteopathy sessions.",[34],"Behavioral: Osteopathy",{"label":36,"type":37,"description":38,"interventionNames":39},"Osteopathy + Hypnosis","EXPERIMENTAL","Patients assigned to this group will benefit from supportive care combining osteopathy and hypnosis.",[34,40],"Behavioral: Hypnosis",[42,46],{"type":43,"name":31,"description":44,"armGroupLabels":45,"otherNames":21},"BEHAVIORAL","An osteopathy session includes a health history chat, physical assessment, hands-on treatment, and aftercare advice.",[31,36],{"type":43,"name":47,"description":48,"armGroupLabels":49,"otherNames":21},"Hypnosis","Hypnosis sessions consisted in deep relaxation and focused concentration, delivered by practitioners trained in the therapy.",[36],[51],{"name":52,"role":53,"phone":54,"phoneExt":21,"email":55},"Alain TOLEDANO, M.D.","CONTACT","+ 33 (0)1 84 00 70 07","alain.toledano@horg.fr",[57],{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Levallois-Perret","Île-de-France Region","92300","France","FR",{"type":65,"coordinates":66},"Point",[67,68],2.28864,48.89389,{"lat":68,"lon":67},[71,75,78],{"name":72,"role":53,"phone":73,"phoneExt":21,"email":74},"Nathaniel SCHER, M.D.","+ 33 (0)1 47 58 05 96","n.scher@rt-hartmann.fr",{"name":76,"role":53,"phone":54,"phoneExt":21,"email":77},"Daniele GRAZZIOTIN, PharmD, PhD","daniele.grazz@institut-rafael.fr",{"name":79,"role":80,"phone":21,"phoneExt":21,"email":21},"Alain TOLEDANO, M.D","PRINCIPAL_INVESTIGATOR",{"type":82,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[84],{"name":85,"class":6},"Hartmann Oncology Radiotherapy Group, France","100659128","impact-of-therapeutic-osteopathy-hypnosis-on-cancer-patients-100659128",false,"NCT07860476","Impact of Therapeutic Osteopathy-hypnosis on Cancer Patients.","Functional and Psychological Evaluation of Combined Osteopathy and Therapeutic Hypnosis in Cancer Patients Living With Chronic Pain: a Randomized Study Comparing Osteopathy and Hypnosis With Osteopathy Alone.","HYPOSTEO","Inclusion Criteria:\n\n* 18 years,\n* Patient diagnosed with cancer (currently undergoing treatment or having completed oncological treatment),\n* Experiencing chronic pain (≥ 3 months),\n* Presenting a strong emotional component to the pain: K10 score between 20 and 29,\n* Patient able to attend all visits and follow study procedures,\n* Patient who has provided consent.\n\nExclusion Criteria:\n\n* Patients with no emotional distress or with severe distress\n* Sensory (auditory, visual) or cognitive deficits likely to hinder the conduct of hypnosis sessions\n* Patient who has undergone hypnotherapy sessions within the last 3 months\n* Patient unable to provide consent","ALL","18 Years",{"count":97,"type":98},80,"ESTIMATED","INTERVENTIONAL",[101],"NA","Osteopathy is recognized as a beneficial complementary approach for cancer patients. By addressing tissue mobility, circulation, and muscle tension, it helps improve physical comfort, reduce musculoskeletal pain, and foster better functional recovery. Several studies have shown that osteopathy can help reduce pain intensity and improve the quality of life for patients undergoing cancer treatment.\n\nCombining hypnosis with osteopathy could thus optimize treatment outcomes by integrating a holistic approach that addresses both physical and psychological needs. The aim of this study is to evaluate the impact of combined osteopathy and hypnosis treatment compared to osteopathic treatment alone in cancer patients, particularly regarding pain with a strong emotional component.",[104],"Cancer",[106,107,108,109,110,111,112,113,114],"osteopathy","hypnosis","holistic approach","integrative medicine","cancer","cancer care","pain management","chronic pain","supportive care","2026-10-06",{"date":117,"type":118},"2026-10-09","ACTUAL",{"date":120,"type":118},"2026-09-30",{"date":122,"type":98},"2028-09",{"name":5,"class":6},1]