Caregivers of ICU PatientsNCT03156192
Music Use and Perceived Psycho-social Benefits of Music of Caregivers of Patients in an Intensive Care Unit
A study testing Survey in people with Caregivers of ICU Patients, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate how family caregivers of ICU patients perceive their psycho-social needs and quality of life, how they use music in their everyday life and perceive music as beneficial to themselves. Participants are adult family members of critically ill patients in ICU. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers of ICU Patients
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2017to 12 Jul 2017
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- primary caregivers (family members) of ICU patients
- aged over 20
Who cannot join
- the one who have difficulties in verbal communication due to the history of psychiatric illness or cognitive impairment (e.g., dementia)
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
The purpose of this study is to investigate how family caregivers of ICU patients perceive their psycho-social needs and quality of life, how they use music in their everyday life and perceive music as beneficial to themselves. Participants are adult family members of critically ill patients in ICU. After obtaining the informed consent form, a questionnaire will be distributed to each participant.
Read the detailed description
The purpose of this study is to investigate how family caregivers of ICU patients perceive their psycho-social needs and quality of life, how they use music in their everyday life and perceive music as beneficial to themselves. Participants are adult family members of critically ill patients in ICU. After obtaining the informed consent form, a questionnaire will be distributed to each participant. The questionnaire consists of Beck Depression Index, Quality of Life scale, and the self-reported items on music use in everyday lives and perceived benefits of music. Based on the completed measures, how caregivers of ICU patients use music and perceive music as beneficial media for their psycho-social health will be analyzed in relation to demographic information and the current level of depression and quality of life.
- Conditions
- Caregivers of ICU Patients
- Being tested
- Survey
- Keywords
- Caregivers, Family-centered care, Music use, Psycho-social benefits of music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
Survey on the level of depression, quality of life, current and past music experiences, and perceived benefits of music in relation to psycho-social needs
| Study group | Role | What they receive |
|---|---|---|
| Caregivers of ICU patients | Experimental | Caregivers (family member) aged over 20 who provides care to ICU patients Receives: Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Index
Measured: a single point in time obtaining the questionnaire (1 day)
quality of Life questionnaire
Measured: a single point in time obtaining the questionnaire (1 day)
self-reported music use and perceived benefits of music questionnaire
Measured: a single point in time obtaining the questionnaire (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Jan 2017
- Primary completion12 Jul 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 200 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
- NCT03156192
- Sponsor's protocol ID
- 4-2016-1028
- Status last verified
- Nov 2017
- First submitted
- 15 May 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Auerbach SM, Kiesler DJ, Wartella J, Rausch S, Ward KR, Ivatury R. Optimism, satisfaction with needs met, interpersonal perceptions of the healthcare team, and emotional distress in patients' family members during critical care hospitalization. Am J Crit Care. 2005 May;14(3):202-10.
PubMed 15840894Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
PubMed 15665319Davidson JE. Family-centered care: meeting the needs of patients' families and helping families adapt to critical illness. Crit Care Nurse. 2009 Jun;29(3):28-34; quiz 35. doi: 10.4037/ccn2009611. No abstract available.
PubMed 19487778Chien WT, Chiu YL, Lam LW, Ip WY. Effects of a needs-based education programme for family carers with a relative in an intensive care unit: a quasi-experimental study. Int J Nurs Stud. 2006 Jan;43(1):39-50. doi: 10.1016/j.ijnurstu.2005.01.006. Epub 2005 Sep 22.
PubMed 16183062
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Use and Perceived Psycho-social Benefits of Music of Caregivers of Patients in an Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03156192
- Acronym / sponsor ID
- 4-2016-1028
- Conditions
- Caregivers of ICU Patients
- Keywords
- Caregivers, Family-centered care, Music use, Psycho-social benefits of music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 17 May 2017 (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.
The purpose of this study is to investigate how family caregivers of ICU patients perceive their psycho-social needs and quality of life, how they use music in their everyday life and perceive music as beneficial to themselves. Participants are adult family members of critically ill patients in ICU. After obtaining the informed consent form, a questionnaire will be distributed to each participant.
Detailed description
The purpose of this study is to investigate how family caregivers of ICU patients perceive their psycho-social needs and quality of life, how they use music in their everyday life and perceive music as beneficial to themselves. Participants are adult family members of critically ill patients in ICU. After obtaining the informed consent form, a questionnaire will be distributed to each participant. The questionnaire consists of Beck Depression Index, Quality of Life scale, and the self-reported items on music use in everyday lives and perceived benefits of music. Based on the completed measures, how caregivers of ICU patients use music and perceive music as beneficial media for their psycho-social health will be analyzed in relation to demographic information and the current level of depression and quality of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers of ICU patients | Experimental | Behavioral: SurveyCaregivers (family member) aged over 20 who provides care to ICU patients |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary caregivers (family members) of ICU patients
- aged over 20
Key exclusion criteria (1 listed)
- the one who have difficulties in verbal communication due to the history of psychiatric illness or cognitive impairment (e.g., dementia)
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 |
|---|---|---|
| SurveySurvey on the level of depression, quality of life, current and past music experiences, and perceived benefits of music in relation to psycho-social needs | Behavioural | Caregivers of ICU patients |
Primary outcome
Beck Depression Index
Time frame: a single point in time obtaining the questionnaire (1 day)
quality of Life questionnaire
Time frame: a single point in time obtaining the questionnaire (1 day)
self-reported music use and perceived benefits of music questionnaire
Time frame: a single point in time obtaining the questionnaire (1 day)
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 14 Nov 2017.
- Background: PubMed 15840894Auerbach SM, Kiesler DJ, Wartella J, Rausch S, Ward KR, Ivatury R. Optimism, satisfaction with needs met, interpersonal perceptions of the healthcare team, and emotional distress in patients' family members during critical care hospitalization. Am J Crit Care. 2005 May;14(3):202-10.
- Background: PubMed 15665319Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
- Background: PubMed 19487778Davidson JE. Family-centered care: meeting the needs of patients' families and helping families adapt to critical illness. Crit Care Nurse. 2009 Jun;29(3):28-34; quiz 35. doi: 10.4037/ccn2009611. No abstract available.
- Background: PubMed 16183062Chien WT, Chiu YL, Lam LW, Ip WY. Effects of a needs-based education programme for family carers with a relative in an intensive care unit: a quasi-experimental study. Int J Nurs Stud. 2006 Jan;43(1):39-50. doi: 10.1016/j.ijnurstu.2005.01.006. Epub 2005 Sep 22.
- Individual participant dataSharing planned: No
Related trials for Caregivers of ICU Patients
Not yet recruiting
Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)
Caregiver, ICU Patients
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 Survey in people with 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 2 inclusion and 1 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 14 Nov 2017. 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?
Beck Depression Index (time frame: a single point in time obtaining the questionnaire (1 day)). The study lists 3 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 NCT03156192, which also lists 4 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 14 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.