Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-17 @ 1:00 PM
Study NCT ID:
NCT01837732
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2013-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Relational Touch in Painful Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080105', 'term': 'Relational Autonomy'}], 'ancestors': [{'id': 'D026684', 'term': 'Personal Autonomy'}, {'id': 'D028662', 'term': 'Principle-Based Ethics'}, {'id': 'D004989', 'term': 'Ethics'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-03', 'studyFirstSubmitDate': '2013-04-02', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SCALE DOLOPLUS BEHAVIORAL ASSESSMENT OF PAIN IN THE ELDERLY (DOLOPLUS pain score variations)', 'timeFrame': 'change from baseline to 4th week', 'description': 'Pain assessment : DOLOPLUS pain score variations at baseline and in the 4th week following the intervention (for all patients)'}], 'secondaryOutcomes': [{'measure': 'Scale of Guy (Pain related symptoms)', 'timeFrame': 'at 3th week and 4th week', 'description': 'Pain related symptoms variation at 3th week (session 6) and 4th week (session 9)(for all patients)'}, {'measure': 'Global benefit questionary', 'timeFrame': '2 sessions per week for 4 weeks and one after the 6 sessions', 'description': 'Global benefit : 2 sessions per week for 4 weeks and one after the 6 sessions following the intervention (for all patients)'}, {'measure': 'Acceptability rate at each session', 'timeFrame': '2 sessions per week for 3 weeks and in 4 th week', 'description': 'Acceptability rate at each session and proportion of the patients completing the whole treatment (for all patients)'}, {'measure': 'score variations of Verbal Rating Scale (VRS)', 'timeFrame': 'change from baseline to 4th week', 'description': 'Pain variation according to VRS at baseline and in the 4th week following the intervention (for communicative patients only)'}, {'measure': 'Global benefit questionary (nurse, doctor, carer)', 'timeFrame': 'after the 6 sessions', 'description': 'Global benefit : 2 after the 6 sessions following the intervention by nurse, doctor, carer for all patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic pain', 'elderly', 'relational touch'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'The aim is to investigate the feasibility and efficacy of a relational touch / relational intervention on persistent pain in a long term geriatric hospital care ward population. The main issue is the pain reduction. The hypothesis is that this type of intervention is very useful on pain reduction in old people even with physical or mental disability.', 'detailedDescription': "The first 74 patients wanting to participate are randomly assigned to 2 groups: relational- touch or relational. Inclusion criteria are : patients with chronic pain; age \\>65y and informed consent. Where patients had mental impairment the family's agreement is solicited. The regional Ethics Committee agreement was granted. The intervention consists of 6 Relational versus Relational- Touch sessions (twice a week) .Evaluation takes place after the second, 4th and 6th sessions and in the 4th week following the intervention. The main outcome is the pain reduction.\n\nThe primary outcome measure is the pain reduction according to the DOLOPLUS scale and the VRS; the secondary outcomes measures are : patient's participation rate; pain related symptoms variation; overall benefit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>65 y\n* Chronic pain \\> 3 months\n* Follow up 4 weeks\n* Patient's speak french\n* Patient's or representative's agreement to participate and to the informatics treatment of the data\n\nExclusion Criteria:\n\n* acute pain\n* unstable clinical status"}, 'identificationModule': {'nctId': 'NCT01837732', 'acronym': 'EFFITOUREL', 'briefTitle': 'Effectiveness of Relational Touch in Painful Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Effectiveness of Relational Touch in the Management of Chronic Pain in Institutionalized Elderly', 'orgStudyIdInfo': {'id': 'K110702'}, 'secondaryIdInfos': [{'id': '2012-AO1042-41', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: relational touch', 'description': 'Relational touch 15 mn " relational touch", hand touch (neck, face and head)', 'interventionNames': ['Other: Relational Touch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B: relational', 'description': "Relational: 10 mn verbal patient's centered exchanges", 'interventionNames': ['Other: Relational:']}], 'interventions': [{'name': 'Relational Touch', 'type': 'OTHER', 'description': 'Relational touch 15 mn " relational touch", hand touch (neck, face and head)', 'armGroupLabels': ['A: relational touch']}, {'name': 'Relational:', 'type': 'OTHER', 'description': "Relational: 10 mn verbal patient's centered exchanges", 'armGroupLabels': ['B: relational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93270', 'city': 'Sevran', 'country': 'France', 'facility': 'Hopital René Muret - Head of department Long Term hospital ward', 'geoPoint': {'lat': 48.94472, 'lon': 2.52746}}], 'overallOfficials': [{'name': 'Philippe JOSEPH-SYLVESTRE, Nurse', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}