NCT03156192

Brief 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. After obtaining the informed consent form, a questionnaire will be distributed to each participant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

May 15, 2017

Last Update Submit

November 9, 2017

Conditions

Caregivers of ICU Patients

Keywords

CaregiversFamily-centered careMusic usePsycho-social benefits of music

Outcome Measures

Primary Outcomes (3)

  • Beck Depression Index

    a single point in time obtaining the questionnaire (1 day)

  • quality of Life questionnaire

    a single point in time obtaining the questionnaire (1 day)

  • self-reported music use and perceived benefits of music questionnaire

    a single point in time obtaining the questionnaire (1 day)

Study Arms (1)

Caregivers of ICU patients

EXPERIMENTAL

Caregivers (family member) aged over 20 who provides care to ICU patients

Behavioral: Survey

Interventions

SurveyBEHAVIORAL

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

Caregivers of ICU patients

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary caregivers (family members) of ICU patients
  • aged over 20

You may not qualify if:

  • the one who have difficulties in verbal communication due to the history of psychiatric illness or cognitive impairment (e.g., dementia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 03722, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 15840894BACKGROUND

  • 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.

    PMID: 15665319BACKGROUND

  • 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.

    PMID: 19487778BACKGROUND

  • 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.

    PMID: 16183062BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 17, 2017

Study Start

January 1, 2017

Primary Completion

July 12, 2017

Study Completion

July 12, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)