Clinical trial NCT03389568: The Effects of Singing-based Music Therapy Program on the Level of Psychoemotional Benefits in Caregivers of ICU Patients
Official title: The Effects of Singing-based Music Therapy Program on the Level of Psychoemotional Benefits in Caregivers of ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Family Caregivers of ICU Patients
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 5 minutes before the intervention
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 5 minutes after the intervention
Secondary outcomes:
measure: State Anxiety Inventory (STAI) for anxiety
timeFrame: 5 minutes before the intervention
measure: State Anxiety Inventory (STAI) for anxiety
timeFrame: 5 minutes after the intervention
measure: VAS(Visual Analog Scale) for emotional state
timeFrame: 5 minutes before the intervention
measure: VAS(Visual Analog Scale) for emotional state
timeFrame: 5 minutes after the intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
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.
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.
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.