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Completed

NCT Number: NCT03389568

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

singing-based music therapy program

Behavioral

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).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 3, 2018
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.