Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT05677412
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2023-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep, Pain and Stress in Adolescents With Persistent 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Experimental within-subject study design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2023-01-09', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep quality', 'timeFrame': 'one night', 'description': 'The overnight PSG (Somnomedics) is used to measure sleep during two nights (Somnomedics, Somnoscreen plus HD), with the following recorded parameters: electroencephalography (left and right for F, C, O); left and right eletrooculogram; left and right electromyogram; electrocardiogram. Sleep recordings are done with portable devices so that the patients will sleep at their home during the recordings.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Chronic', 'Sleep']}, 'descriptionModule': {'briefSummary': 'The main aim is the gain information of sleep structures in adolescents with persistent pain. Also to study simple interventions to support their sleep and pain management. The main aim of this study is to test the efficacy and feasibility of suggestive presleep relaxation technique in improving sleep quality and sleep-related emotional memory processing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 15-17 years with persistent (\\> 3months) pain reporting average pain intensity over 3/10 on the Numerical Rating Scale (NRS).\n\nExclusion Criteria:\n\n* ongoing medication for sleep or pain.'}, 'identificationModule': {'nctId': 'NCT05677412', 'acronym': 'PedPainSleep', 'briefTitle': 'Sleep, Pain and Stress in Adolescents With Persistent Pain', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Sleep, Pain and Stress in Adolescents With Persistent Pain', 'orgStudyIdInfo': {'id': 'ULSHelsinki'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'neutral story', 'description': 'Neutral story before the sleep onset', 'interventionNames': ['Behavioral: Neutral story']}, {'type': 'EXPERIMENTAL', 'label': 'suggestive story', 'description': 'Suggestive story to find out the effect of relaxation to sleep structures.', 'interventionNames': ['Behavioral: suggestive relaxation']}], 'interventions': [{'name': 'suggestive relaxation', 'type': 'BEHAVIORAL', 'description': 'suggestive story before sleep onset', 'armGroupLabels': ['suggestive story']}, {'name': 'Neutral story', 'type': 'BEHAVIORAL', 'description': 'neutral story before sleep', 'armGroupLabels': ['neutral story']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Reetta M Sipilä, PhD', 'role': 'CONTACT', 'email': 'reetta.sipila@hus.fi', 'phone': '+358406812427'}], 'facility': 'New Childrens Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Reetta M Sipilä, PhD', 'role': 'CONTACT', 'email': 'reetta.sipila@hus.fi', 'phone': '+358406812427'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Helsinki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of research', 'investigatorFullName': 'Reetta Sipilä', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}