- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03389568
The Effects of Singing-based Music Therapy Program on the Level of Psychoemotional Benefits in Caregivers of ICU Patients
10 januari 2019 uppdaterad av: Yonsei University
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
- 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.
Studietyp
Interventionell
Inskrivning (Faktisk)
22
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Seoul, Korea, Republiken av, 03722
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 100 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Intervention for caregivers of ICU patients
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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).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Center for Epidemiologic Studies Depression Scale (CES-D)
Tidsram: 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.
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5 minutes before the intervention
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Center for Epidemiologic Studies Depression Scale (CES-D)
Tidsram: 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.
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5 minutes after the intervention
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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State Anxiety Inventory (STAI) for anxiety
Tidsram: 5 minutes before the intervention
|
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.
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5 minutes before the intervention
|
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State Anxiety Inventory (STAI) for anxiety
Tidsram: 5 minutes after the intervention
|
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.
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5 minutes after the intervention
|
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VAS(Visual Analog Scale) for emotional state
Tidsram: 5 minutes before the intervention
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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.
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5 minutes before the intervention
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VAS(Visual Analog Scale) for emotional state
Tidsram: 5 minutes after the intervention
|
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.
|
5 minutes after the intervention
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Samarbetspartners och utredare
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Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2018
Primärt slutförande (Faktisk)
3 april 2018
Avslutad studie (Faktisk)
3 april 2018
Studieregistreringsdatum
Först inskickad
20 december 2017
Först inskickad som uppfyllde QC-kriterierna
27 december 2017
Första postat (Faktisk)
3 januari 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 januari 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 januari 2019
Senast verifierad
1 januari 2019
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 4-2017-0963
Plan för individuella deltagardata (IPD)
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NEJ
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