Primary Family Caregivers of ICU PatientsNCT03389568
The Effects of Singing-based Music Therapy Program on the Level of Psychoemotional Benefits in Caregivers of ICU Patients
A study testing singing-based music therapy program in people with Primary Family Caregivers of ICU Patients, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Family Caregivers of ICU Patients
- What is being tested?
- singing-based music therapy program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2018to 3 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 03722
About this study
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.
Read the 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.
- Being tested
- singing-based music therapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
singing-based music therapy programBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention for caregivers of ICU patients | Experimental | Not described Receives: Behavioral: singing-based music therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiologic Studies Depression Scale (CES-D)
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.
Measured: 5 minutes before the intervention
Center for Epidemiologic Studies Depression Scale (CES-D)
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.
Measured: 5 minutes after the intervention
Secondary outcomes (4)
State Anxiety Inventory (STAI) for anxiety
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.
Measured: 5 minutes before the intervention
State Anxiety Inventory (STAI) for anxiety
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.
Measured: 5 minutes after the intervention
VAS(Visual Analog Scale) for emotional state
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.
Measured: 5 minutes before the intervention
VAS(Visual Analog Scale) for emotional state
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.
Measured: 5 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start1 Feb 2018
- Primary completion3 Apr 2018
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Family Caregivers of ICU PatientsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389568
- Sponsor's protocol ID
- 4-2017-0963
- Status last verified
- Jan 2019
- First submitted
- 20 Dec 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20124890Melnyk 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.
PubMed 15173543O'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.
PubMed 18928132
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Singing-based Music Therapy Program on the Level of Psychoemotional Benefits in Caregivers of ICU Patients
- ClinicalTrials.gov ID
- NCT03389568
- Acronym / sponsor ID
- 4-2017-0963
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention for caregivers of ICU patients | Experimental | Behavioral: singing-based music therapy program |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| singing-based music therapy programA 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). | Behavioural | Intervention for caregivers of ICU patients |
Primary outcome
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.
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.
4 secondary outcomes
State Anxiety Inventory (STAI) for anxiety
Time frame: 5 minutes before the intervention
State Anxiety Inventory (STAI) for anxiety
Time frame: 5 minutes after the intervention
VAS(Visual Analog Scale) for emotional state
Time frame: 5 minutes before the intervention
VAS(Visual Analog Scale) for emotional state
Time frame: 5 minutes after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Results publication: PubMed 20124890McAdam 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.
- Results publication: PubMed 15173543Melnyk 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.
- Results publication: PubMed 18928132O'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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing singing-based music therapy program in people with Primary Family Caregivers of ICU Patients, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center for Epidemiologic Studies Depression Scale (CES-D) (time frame: 5 minutes before the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03389568, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.