- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03156192
Music Use and Perceived Psycho-social Benefits of Music of Caregivers of Patients in an Intensive Care Unit
November 9, 2017 updated by: Yonsei University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 03722
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- primary caregivers (family members) of ICU patients
- aged over 20
Exclusion Criteria:
- the one who have difficulties in verbal communication due to the history of psychiatric illness or cognitive impairment (e.g., dementia)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Caregivers of ICU patients
Caregivers (family member) aged over 20 who provides care to ICU patients
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Beck Depression Index
Time Frame: a single point in time obtaining the questionnaire (1 day)
|
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)
|
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)
|
a single point in time obtaining the questionnaire (1 day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Azoulay 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.
- 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.
- Davidson 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.
- Chien 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
July 12, 2017
Study Completion (Actual)
July 12, 2017
Study Registration Dates
First Submitted
May 15, 2017
First Submitted That Met QC Criteria
May 16, 2017
First Posted (Actual)
May 17, 2017
Study Record Updates
Last Update Posted (Actual)
November 14, 2017
Last Update Submitted That Met QC Criteria
November 9, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 4-2016-1028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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