Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 11:18 AM
Study NCT ID:
NCT07404904
Status:
COMPLETED
Last Update Posted:
2026-02-12
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Touch on Pain, Delirium, Sleep, and Physiological Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019124', 'term': 'Therapeutic Touch'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants do not know which group they are in the study.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS (Visual Analog Scale)', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).', 'description': 'Pain intensity measured using a 0-10 Visual Analog Scale (0 = no pain, 10 = worst pain).'}, {'measure': 'RASS (Richmond Agitation and Sedation Scale)', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).', 'description': 'Sedation/agitation level scored from +4 (combative) to -5 (unarousable).'}, {'measure': 'RCSQ (Richards-Campbell Sleep Questionnaire)', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).', 'description': 'Sleep quality assessed with RCSQ, range 0-100.'}, {'measure': 'Blood pressure', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).', 'description': 'Systolic and diastolic blood pressure measured using standard bedside monitoring in the intensive care unit.'}, {'measure': 'Heart rate', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).', 'description': 'Heart rate measured using continuous bedside cardiac monitoring in the intensive care unit.'}, {'measure': 'Respiratory rate', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).', 'description': 'Respiratory rate measured and recorded as breaths per minute using bedside monitoring.'}, {'measure': 'Body temperature', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).', 'description': 'Body temperature measured using a standard clinical thermometer in the intensive care unit.'}, {'measure': 'Oxygen saturation', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).', 'description': 'Peripheral oxygen saturation measured by pulse oximetry.'}], 'secondaryOutcomes': [{'measure': 'VAS (Visual Analog Scale)', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).', 'description': 'Pain intensity measured using a 0-10 Visual Analog Scale.'}, {'measure': 'RASS (Richmond Agitation and Sedation Scale)', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).', 'description': 'Sedation/agitation scored from +4 to -5.'}, {'measure': 'RCSQ (Richards-Campbell Sleep Questionnaire)', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).', 'description': 'Sleep quality assessed with RCSQ, range 0-100.'}, {'measure': 'Blood pressure', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).', 'description': 'Systolic and diastolic blood pressure measured using standard bedside monitoring in the intensive care unit.'}, {'measure': 'Heart rate', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).', 'description': 'Heart rate measured using continuous bedside cardiac monitoring in the intensive care unit.'}, {'measure': 'Respiratory rate', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).', 'description': 'Respiratory rate measured and recorded as breaths per minute using bedside monitoring.'}, {'measure': 'Body temperature', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).', 'description': 'Body temperature measured using a standard clinical thermometer in the intensive care unit.'}, {'measure': 'Oxygen saturation', 'timeFrame': 'At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).', 'description': 'Peripheral oxygen saturation measured by pulse oximetry.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Therapeutic Touch', 'Pain', 'Sleep Quality', 'Delirium Level'], 'conditions': ['Sleep Disturbance', 'Delirium']}, 'descriptionModule': {'briefSummary': 'The study was conducted to determine the effects of therapeutic touch applied to intensive care patients on pain, delirium, sleep and physiological parameters.', 'detailedDescription': 'This study aims to evaluate the effects of therapeutic touch on pain, delirium, sleep, and physiological parameters in surgical intensive care patients. Patients will be assessed at 24, 48, and 72 hours. The intervention and control groups will be randomized. The intervention group will receive routine care and therapeutic touch, while the control group will receive only routine care. Parameters will be assessed before and after each measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who volunteer to participate in the study,\n* Patients aged 18 and over who receive post-surgical treatment at the Surgical Intensive Care Unit of Aksaray Education and Research Hospital,\n* Patients who do not have communication problems (hearing, speaking, understanding, etc.),\n* Patients who have received treatment in the surgical intensive care unit for at least 72 hours,\n* Patients with RASS: between -3 and +4 and Glasgow coma scale: 10 and above,\n* Patients who use only non-steroidal drugs as analgesics,\n* Patients whose medical diagnosis is not dementia,\n* Patients who do not have a mental state disorder/psychological disease and do not use sleeping pills.\n\nExclusion Criteria:\n\n* Patients who developed complications in the ICU after surgery,\n* Patients who received treatment in the surgical intensive care unit for less than 72 hours.'}, 'identificationModule': {'nctId': 'NCT07404904', 'briefTitle': 'Therapeutic Touch on Pain, Delirium, Sleep, and Physiological Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Aksaray University'}, 'officialTitle': 'Evaluation of the Effects of Therapeutic Touch on Pain, Delirium, Sleep, and Physiological Parameters in Intensive Care Patients', 'orgStudyIdInfo': {'id': 'Aksaray Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Randomized control', 'description': 'Experimental (therapeutic touch)', 'interventionNames': ['Other: therapeutic touch']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control (routine care)'}], 'interventions': [{'name': 'therapeutic touch', 'type': 'OTHER', 'otherNames': ['routine maintenance'], 'description': 'therapeutic touch', 'armGroupLabels': ['Randomized control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Aksaray', 'country': 'Turkey (Türkiye)', 'facility': 'Aksaray Universitesi', 'geoPoint': {'lat': 38.37255, 'lon': 34.02537}}], 'overallOfficials': [{'name': 'Sibel Öksüz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aksaray University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sibel Oksuz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aksaray University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sibel Oksuz', 'investigatorAffiliation': 'Aksaray University'}}}}