Pediatric Laser Acupuncture and Renal Biopsy
Efficacy of Laser Therapy as an Adjuvant Treatment During Kidney Biopsies to Decrease Anxiety and Pain.
The purpose of this study is to test if treatment with laser therapy in pediatric patients undergoing renal biopsies will improve patient satisfaction of the overall procedure. In this study, the participant will receive a laser acupuncture treatment targeting either kidney acupoints or targeting "sham" points not associated with the kidney; the participant will not get both. Both treatment sessions are given by a certified medical acupuncturist. The patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure. All medication will be administered without regard for which group the participant has been randomized, as the treatment team will also be blinded.
Hypothesis:
We will test the hypothesis that treatment with laser acupuncture in patients undergoing renal biopsies will improve patient satisfaction of the overall procedure.
Specific Aims:
Specific Aim 1: Determine whether the use of laser acupuncture improves patient's overall satisfaction of renal biopsy.
Specific Aim 2: Determine whether the use of laser acupuncture decreases the amount of sedative medication given during renal biopsy.
調査の概要
詳細な説明
At University of California San Francisco, there are approximately 100 pediatric renal biopsies per year. All of these patients receive sedation, which is prescribed and supervised by the pediatric pain and palliative care team, with either ketamine or fentanyl and versed. Child life is involved; however, many children still experience anxiety and/or pain with the procedure. Use of a modality such as aculaser which may decrease these symptoms could enhance their experience.
The term "laser" stands for light amplification by stimulated emission of radiation. In laser acupuncture, a low power, cold light produced by a low-level laser diode is used to stimulate an acupuncture point. As it is non-invasive, laser acupuncture is thought to be safer than needle acupuncture, especially in the setting of patients with blood-borne infectious diseases. In a systematic review analyzing the evidence to support the effectiveness of laser acupuncture, randomized control trials in which adults with soft tissue injury, acute or chronic pain condition, or any systemic illness were included. This review reports moderate level of evidence for treatment of myofascial pain and post-operative nausea/vomiting and limited evidence of the clinical effectiveness of treating chronic tension headaches. Of note, no complications of the use of aculaser were reported in this review (1).
1. Baxter GD, Bleakley C, McDonough S. Clinical effectiveness of laser acupuncture: a systematic review. J Acupunct Meridian Stud. 2008 Dec;1(2):65-82.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94143
- University of California, San Francisco
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San Francisco、California、アメリカ、94143
- University of California San Francisco Hospital
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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
説明
Inclusion Criteria:
- older than 6 years old
- admitted for a transplant or native kidney biopsy performed by pediatric nephrology
Exclusion Criteria:
- Prisoners
- Pregnant females
- Those who are unable to participate with the visual analog scale
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
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
偽コンパレータ：Aculaser applied to sham points
The patient will receive aculaser, performed by licensed acupuncturist, to "sham" acupuncture sites.
In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.
|
The patient will receive aculaser, performed by licensed acupuncturist, to "sham" acupuncture sites.
In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.
他の名前：
|
|
実験的：Aculaser applied to kidney points
The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites.
In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.
|
The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites.
In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.
他の名前：
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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 |
|---|---|---|
|
Patient Pain/Anxiety
時間枠：1 day
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The patient will complete a visual analog scale (rate 0-10) to assess pain after the procedure.
Zero is no pain and 10 is worse pain.
Change was calculated by baseline minus day one.
|
1 day
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Parent Perception of Patient Pain Report
時間枠：1 day
|
Parent Perception of Patient Pain, scale is from 0 to 10, minimum value is 0, maximum value is 10, higher scores mean better outcome.
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1 day
|
協力者と研究者
捜査官
- 主任研究者：Cynthia Kim, MD、University of California, San Francisco
出版物と役立つリンク
一般刊行物
- Baxter GD, Bleakley C, McDonough S. Clinical effectiveness of laser acupuncture: a systematic review. J Acupunct Meridian Stud. 2008 Dec;1(2):65-82. doi: 10.1016/S2005-2901(09)60026-1.
- Schlager A, Offer T, Baldissera I. Laser stimulation of acupuncture point P6 reduces postoperative vomiting in children undergoing strabismus surgery. Br J Anaesth. 1998 Oct;81(4):529-32. doi: 10.1093/bja/81.4.529.
- Gottschling S, Meyer S, Gribova I, Distler L, Berrang J, Gortner L, Graf N, Shamdeen GM. Laser acupuncture in children with headache: a double-blind, randomized, bicenter, placebo-controlled trial. Pain. 2008 Jul 15;137(2):405-412. doi: 10.1016/j.pain.2007.10.004. Epub 2007 Nov 19.
- Resim S, Gumusalan Y, Ekerbicer HC, Sahin MA, Sahinkanat T. Effectiveness of electro-acupuncture compared to sedo-analgesics in relieving pain during shockwave lithotripsy. Urol Res. 2005 Aug;33(4):285-90. doi: 10.1007/s00240-005-0473-7. Epub 2005 Jun 22.
- Oates A, Benedict KA, Sun K, Brakeman PR, Lim J, Kim C. Laser acupuncture reduces pain in pediatric kidney biopsies: a randomized controlled trial. Pain. 2017 Jan;158(1):103-109. doi: 10.1097/j.pain.0000000000000734.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (実際)
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
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