The Effects of Singing-based Music Therapy Program on the Level of Psychoemotional Benefits in Caregivers of ICU Patients
2019年1月10日 更新者：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.
調査の概要
詳細な説明
- 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.
研究の種類
介入
入学 (実際)
22
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Seoul、大韓民国、03722
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～100年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention for caregivers of ICU patients
|
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).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Center for Epidemiologic Studies Depression Scale (CES-D)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
State Anxiety Inventory (STAI) for anxiety
時間枠：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.
|
5 minutes before the intervention
|
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State Anxiety Inventory (STAI) for anxiety
時間枠：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.
|
5 minutes after the intervention
|
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VAS(Visual Analog Scale) for emotional state
時間枠：5 minutes before 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 before the intervention
|
|
VAS(Visual Analog Scale) for emotional state
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年2月1日
一次修了 (実際)
2018年4月3日
研究の完了 (実際)
2018年4月3日
試験登録日
最初に提出
2017年12月20日
QC基準を満たした最初の提出物
2017年12月27日
最初の投稿 (実際)
2018年1月3日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月11日
QC基準を満たした最後の更新が送信されました
2019年1月10日
最終確認日
2019年1月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 4-2017-0963
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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