Music Therapy: An Adjunct To Gastroschisis Infants' Care (MAGIC)
The Effect of Music Therapy On Infants Born With Gastroschisis
The investigators hope to determine if music therapy will have beneficial effects on physiologic parameters, behavioral states, and pain scale evaluations in infants with gastroschisis defects and if music therapy promotes parental/caregiver relaxation and demonstrates to the parent/caregiver that music is an effective tool to calm and soothe their infant at risk for chronic gastrointestinal discomfort.
Babies will be enrolled during the perinatal period, with therapy to begin after surgical repair of the gastroschisis defect and when the neonatologist deems the baby stable enough for music therapy intervention. Enrolled subjects may receive up to 3 music therapy sessions/week and these sessions may continue until discharge. There is no follow up after discharge.
Each one hour session (20-30 minutes of music and 30 minutes of quiet) will include:
- Pre music therapy behavior state will be assessed using CRIES scale and recorded.
- Five minutes of baseline vital signs will be recorded.
- Music therapy lasting 20-30 minutes, will start. Music therapist will use guitar and lap harp to perform live lullaby tupe music with or with out vocals. Decibel levels will be maintained at 65-75dB. Session will stop if infant shows any signs of distress/agitation. Vital signs will be collected every 1-4 minutes during music session.
- After session behavior state using CRIES scale will be recorded.
- Family/caregiver will be given a questionnaire to fill out.
- 30 min of quiet will start.
- At the end of quiet time, behavior state and vital signs will be recorded for the last time.
調査の概要
状態
条件
詳細な説明
Prior to starting the music therapy session, family/caregivers, if present, will be informed of study session progression. They will be reminded of appropriate behavioral protocol to maintain therapeutic environment during session - i.e. minimal taking & touching, cell phones off etc. A "Do Not Disturb - Music Therapy Session in Progress" will be posted outside pts room on the door.
Behavioral state data and vitals signs collected during sessions will be entered into a database. Also recorded, will be general information about the baby and its mother, such as, gestational age, apgar scores, mothers age and race, number of days post surgical repair etc.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Catherine T Worwa, LRT, BS, CCRP
- 電話番号:612-813-6864
- メール:cathy.worwa@childrensmn.org
研究場所
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55404
- 募集
- Childrens Hospitals and Clinics of MN
-
コンタクト:
- Catherine T Worwa
- 電話番号:612-813-6864
- メール:cathy.worwa@childrensmn.org
-
主任研究者:
- Ellen Bendel-Stenzel, MD
-
副調査官:
- Melissa Wenszell, MT-BC, NMT
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Diagnosis of Gastroschisis
- Patient is stable enough to receive music therapy as determined by Neonatologist
- Patient has passed their newborn hearing screen
Exclusion Criteria:
1. Neonatologist feels patient/family would not be an acceptable research candidate.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:見込みのある
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 |
---|---|---|
Music Therapy will produce stable physiologic, states as well as, positive behavior states
時間枠:3 years
|
Vital signs monitor data and stress assessment scores will be collected before, during and post Music Therapy sessions
|
3 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1110096A
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。