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The Effects of Singing-based Music Therapy Program on the Level of Psychoemotional Benefits in Caregivers of ICU Patients

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ClinicalTrials.gov Identifier: NCT03389568
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Primary Family Caregivers of ICU Patients Behavioral: singing-based music therapy program

Detailed Description:
  • 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.
  • 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.
  • 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.
  • 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Singing-based Music Therapy Program on the Level of Psychoemotional Benefits in Caregivers of ICU Patients
Anticipated Study Start Date : January 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention for caregivers of ICU patients Behavioral: singing-based music therapy program
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).


Outcome Measures

Primary Outcome Measures :
  1. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 5 minutes before the intervention ]
    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.

  2. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 5 minutes after the intervention ]
    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.


Secondary Outcome Measures :
  1. State Anxiety Inventory (STAI) for anxiety [ Time Frame: 5 minutes before the intervention ]
    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.

  2. State Anxiety Inventory (STAI) for anxiety [ Time Frame: 5 minutes after the intervention ]
    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.

  3. VAS(Visual Analog Scale) for emotional state [ Time Frame: 5 minutes before the intervention ]
    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.

  4. VAS(Visual Analog Scale) for emotional state [ Time Frame: 5 minutes after the intervention ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 18 years and over
  • Family members (spouse, parents, or children) of patients who stay in the ICU for more than 3 days
  • Provision of the majority of unpaid physical, emotional, and/or instrumental care to the patients
  • Voluntarily agreement with participation in the study

Exclusion Criteria:

  • A history of cognitive impairment (e.g., dementia), psychiatric disorders or neurological disorders
  • Indication of discernible hearing deficits
  • Difficulties in verbal communication
  • If the caregiver's relationship to a patient is close friend or relatives (not immediate family of patients)
  • Refusal to participate in the study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389568


Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine Not yet recruiting
Seoul, Korea, Republic of, 03722
Contact: Sungwon Na, MD    82-2-2228-2420    nswksj@yuhs.ac   
Sponsors and Collaborators
Yonsei University