Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-16 @ 7:57 AM
Study NCT ID:
NCT03389568
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Singing-based Music Therapy Program on the Level of Psychoemotional Benefits in Caregivers of ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2017-12-20', 'studyFirstSubmitQcDate': '2017-12-27', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': '5 minutes before the intervention', 'description': 'This study aimed to examine the changes in the measured CES-D in caregivers of ICU patients after participation in music therapy intervention. CES-D is the self-administered scale and consists of Likert-type 20 items on depressed affect, positive affect, somatic activity, and interpersonal relationship. The value measured from this scale indicates a level of depressive symptoms.'}, {'measure': 'Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': '5 minutes after the intervention', 'description': 'This study aimed to examine the changes in the measured CES-D in caregivers of ICU patients after participation in music therapy intervention. CES-D is the self-administered scale and consists of Likert-type 20 items on depressed affect, positive affect, somatic activity, and interpersonal relationship. The value measured from this scale indicates a level of depressive symptoms.'}], 'secondaryOutcomes': [{'measure': 'State Anxiety Inventory (STAI) for anxiety', 'timeFrame': '5 minutes before the intervention', 'description': 'As the secondary outcomes of intervention, changes in the level of anxiety are measured. The level of anxiety is measured by scores on State Anxiety Inventory (STAI). STAI is the self-administered scale and consists of 4-Likert type of 20 items on the perceived emotions in terms of anxiety.'}, {'measure': 'State Anxiety Inventory (STAI) for anxiety', 'timeFrame': '5 minutes after the intervention', 'description': 'As the secondary outcomes of intervention, changes in the level of anxiety are measured. The level of anxiety is measured by scores on State Anxiety Inventory (STAI). STAI is the self-administered scale and consists of 4-Likert type of 20 items on the perceived emotions in terms of anxiety.'}, {'measure': 'VAS(Visual Analog Scale) for emotional state', 'timeFrame': '5 minutes before the intervention', 'description': 'As the secondary outcomes of intervention, changes in the level of emotional states are measured. For emotional states, a 100mm visual analog scale (VAS) is used for participants to rate how they feel happiness, sadness, anger, fear, and comfort.'}, {'measure': 'VAS(Visual Analog Scale) for emotional state', 'timeFrame': '5 minutes after the intervention', 'description': 'As the secondary outcomes of intervention, changes in the level of emotional states are measured. For emotional states, a 100mm visual analog scale (VAS) is used for participants to rate how they feel happiness, sadness, anger, fear, and comfort.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Family Caregivers of ICU Patients']}, 'referencesModule': {'references': [{'pmid': '20124890', 'type': 'RESULT', 'citation': 'McAdam JL, Dracup KA, White DB, Fontaine DK, Puntillo KA. Symptom experiences of family members of intensive care unit patients at high risk for dying. Crit Care Med. 2010 Apr;38(4):1078-85. doi: 10.1097/CCM.0b013e3181cf6d94.'}, {'pmid': '15173543', 'type': 'RESULT', 'citation': 'Melnyk BM, Alpert-Gillis L, Feinstein NF, Crean HF, Johnson J, Fairbanks E, Small L, Rubenstein J, Slota M, Corbo-Richert B. Creating opportunities for parent empowerment: program effects on the mental health/coping outcomes of critically ill young children and their mothers. Pediatrics. 2004 Jun;113(6):e597-607. doi: 10.1542/peds.113.6.e597.'}, {'pmid': '18928132', 'type': 'RESULT', 'citation': "O'Kelly J. Saying it in song: music therapy as a carer support intervention. Int J Palliat Nurs. 2008 Jun;14(6):281-6. doi: 10.12968/ijpn.2008.14.6.30023."}]}, 'descriptionModule': {'briefSummary': 'This study applies an one-group pre-posttest design. Primary family caregivers of ICU patients are recruited. After obtaining an informed consent form from each participant, he or she participates in an individual 1-hour singing-based music therapy intervention. At pre- and posttest, the changes in the level of depression, anxiety, and emotional states are measured.', 'detailedDescription': "* Background: Family caregivers of ICU patients experience high level of distress due to the severity of illness that their family members demonstrate and the perceived limitation in control during their caregiving. This psychological issue in family caregivers have been documented to affect not only the caregivers' psychosocial health but also the quality of care for patients, which would also be influencing factors for treatment outcomes of patients. As such, family-centered care has been emphasized in related professions. Intervention efforts for family caregivers are also of interest. Given that music has been evidenced to effectively alleviate emotional stress of caregivers and that musical activities can be used in an individualized way at different levels, the use of music for addressing psychosocial needs of this population is potential. Among musical activities, singing is one of the most common activities and also available in everyday life regardless of the level of musical background in the past, which increases the possibility to utilize it as a personal strategy for individuals with a broad range of musical experiences and music use.\n* Purpose: This study aimed to examine the changes in the level of depression, anxiety, and emotional states of family caregivers of ICU patients after participation in singing-based music therapy intervention.\n* Intervention: Singing-based music therapy program consists of the sequences of the following: (1) listening to a participant's preferred music and identifying his and her emotional states, (2) singing for emotional changes, and (3) discussing what he or she experiences during singing and identifying how they apply such experience to their personal use of music for emotional changes in his or her everyday life.\n* Measures: In order to examine the changes in the perceived psychological health after participation in singing-based intervention, Center for Epidemiologic Studies Depression Scale (CES-D), State Anxiety Inventory (STAI), and a 100mm visual analog scale for ratings on emotional state are administered. Also, in order to identify and control the effect of level of caregiving burden on current emotional states, Subjective Caregiving Burden Scale is administered."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ages 18 years and over\n* Family members (spouse, parents, or children) of patients who stay in the ICU for more than 3 days\n* Provision of the majority of unpaid physical, emotional, and/or instrumental care to the patients\n* Voluntarily agreement with participation in the study\n\nExclusion Criteria:\n\n* A history of cognitive impairment (e.g., dementia), psychiatric disorders or neurological disorders\n* Indication of discernible hearing deficits\n* Difficulties in verbal communication\n* If the caregiver's relationship to a patient is close friend or relatives (not immediate family of patients)\n* Refusal to participate in the study"}, 'identificationModule': {'nctId': 'NCT03389568', 'briefTitle': 'The Effects of Singing-based Music Therapy Program on the Level of Psychoemotional Benefits in Caregivers of ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Effects of Singing-based Music Therapy Program on the Level of Psychoemotional Benefits in Caregivers of ICU Patients', 'orgStudyIdInfo': {'id': '4-2017-0963'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention for caregivers of ICU patients', 'interventionNames': ['Behavioral: singing-based music therapy program']}], 'interventions': [{'name': 'singing-based music therapy program', 'type': 'BEHAVIORAL', 'description': "A single 1-hour singing-based intervention is conducted with each primary caregiver of an ICU patient. The intervention is composed of three steps: 1) listening to a participant's preferred music and identifying his and her emotional states (15 minutes), (2) singing for emotional changes (30 minutes), and (3) discussing what he or she experiences during singing and identifying how they apply such experience to their personal use of music for emotional changes in his or her everyday life (15 minutes).", 'armGroupLabels': ['Intervention for caregivers of ICU patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}