Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-01-10 @ 3:19 AM
Study NCT ID:
NCT04111861
Status:
UNKNOWN
Last Update Posted:
2021-11-09
First Post:
2019-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Singing for Chronic Pain, a New Intervention for the Management of Chronic Pain
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': 'D063346', 'term': 'Singing'}], 'ancestors': [{'id': 'D010699', 'term': 'Phonation'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-08-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-08', 'studyFirstSubmitDate': '2019-09-10', 'studyFirstSubmitQcDate': '2019-09-30', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Focus Group', 'timeFrame': 'One year', 'description': "At week 10, participants will be invited to take part in a 60 minute focus group led by an experienced researcher. The focus groups will explore participants' perception of the programme and its outcomes, reasons for noncompliance, instrument appropriateness and suggestions for programme improvement"}], 'primaryOutcomes': [{'measure': 'Completion rate', 'timeFrame': 'One year', 'description': 'Measure of attendance at sessions'}, {'measure': 'Consent rate', 'timeFrame': 'One year', 'description': 'Measure of those offered the programme who consent to take part'}], 'secondaryOutcomes': [{'measure': 'Self reported self efficacy', 'timeFrame': 'One year', 'description': 'Pain Self-efficacy questionnaire'}, {'measure': 'Self reported ability to self-manage pain', 'timeFrame': 'One year', 'description': 'Patient Activation Measure questionnaire'}, {'measure': 'Increased mindfulness Increased mindfulness Increased mindfulness', 'timeFrame': 'One year', 'description': 'Frieburg Mindfulness questionnaire'}, {'measure': 'Self reported well-being', 'timeFrame': 'One year', 'description': 'Edinburgh Warwick Well-being questionnaire'}, {'measure': 'Self reported anxiety depression', 'timeFrame': 'One year', 'description': 'Hospital Anxiety and Depression questionnaire.The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Anxiety scores and depression scores can range for 0 -21 with a higher score being worse. The separate depression and anxiety scores scores can be combined to give an overall score.'}, {'measure': 'Self reported quality of life', 'timeFrame': 'One year', 'description': 'EQ5D Quality of Life Questionnaire The EQ-5D questionnaire has two components: health state description and evaluation.Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) or five-level (EQ-5D-5L) scale.\n\nIn the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).he answers given to ED-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'The aim of the project is to determine the feasibility of delivering a Singing for Chronic Pain (SCP) programme to patients with chronic pain attending a pain clinic.\n\nThe investigator will also be looking to provide a preliminary estimate of the benefit of SCP on self-efficacy, self -management skills, mindfulness and well-being as measured by standardized outcome measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older and have a diagnosis of chronic pain with a duration of 6 months or more.\n\nExclusion Criteria:\n\n* Having a mental health and/or physical health diagnosis that might prevent active engagement/participation in group sessions; Severe hearing impairment; Severe/profound cognitive impairment that may limit active engagement/participation in group sessions.'}, 'identificationModule': {'nctId': 'NCT04111861', 'briefTitle': 'Singing for Chronic Pain, a New Intervention for the Management of Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Royal Cornwall Hospitals Trust'}, 'officialTitle': 'Singing for Chronic Pain, a Pilot Study of a New Intervention for the Management of Chronic Pain', 'orgStudyIdInfo': {'id': '2019 RCHT 61'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intevention', 'description': 'To see if singing can be used as a detractive method from patients experiencing ongoing pain.', 'interventionNames': ['Other: Singing']}], 'interventions': [{'name': 'Singing', 'type': 'OTHER', 'description': 'To investigate whether singing can help people to manage their chronic pain the applicants, working together with people with chronic pain, have developed a singing intervention, Singing for Chronic Pain (SCP). The development of the programme has been supported by Snape Moultings, an international centre for the arts which offered the team a residency to develop the programme (https://snapemaltings.co.uk/music/residencies/). The model takes a holistic approach using voice and singing, movement, sound, mindfulness and breath work to provide opportunities to connect body, voice, breath and mind. This is important given that people often use body dissociation as a way to cope with physical pain', 'armGroupLabels': ['Intevention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TR1 3HD', 'city': 'Truro', 'state': 'Cornwall', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Jo Erwin', 'role': 'CONTACT'}], 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}], 'centralContacts': [{'name': 'Josephine Erwin', 'role': 'CONTACT', 'email': 'josephine.erwin@nhs.net', 'phone': '01872 256439'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Cornwall Hospitals Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}