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穴位按压改善住院患者满意度及康复质量的随机试验:一项随机对照试验的研究方案

Randomized trial of acupressure to improve patient satisfaction and quality of recovery in hospitalized patients: study protocol for a randomized controlled trial.

作者信息

Noll Eric, Shodhan Shivam, Madariaga Maria Cecilia, Page Christopher R, Santangelo Diane, Guo Xiaojun, Al Bizri Ehab, Pryor Aurora D, Romeiser Jamie, Bennett-Guerrero Elliott

机构信息

Department of Anesthesiology Stony Brook Medicine, Stony Brook, NY, USA.

Institut de Chirurgie Guidee par l'Image, IHU Hopitaux Universitaire de Strasbourg, Strasbourg, France.

出版信息

Trials. 2017 Mar 7;18(1):110. doi: 10.1186/s13063-017-1839-1.

Abstract

BACKGROUND

Acupressure therapy may be potentially beneficial in improving postoperative symptoms like postoperative nausea and vomiting (PONV), pain and sleep disorder and improving postoperative quality of recovery. The primary aim of this study is to investigate the efficacy of acupressure therapy on postoperative patient satisfaction and quality of recovery in hospitalized patients after surgical treatment.

METHODS/DESIGN: This three-group, parallel, superiority, blinded, randomized controlled trial will test the hypothesis that a combination of PC6, LI4 and HT7 acupressure is superior to sham or no intervention for improving postoperative quality of recovery in hospitalized patients. A minimum of 150 patients will be randomly allocated to one of the three experimental groups: control (no visit), light touch (sham acupressure) or active acupressure therapy in a 1:1:1 ratio. Interventions will be performed three times a day for 2 days. Patient satisfaction, quality of recovery, PONV and pain will be measured during the 3 days following randomization. The study protocol was approved by the Stony Brook University Institutional Review Board on 21 March 2016. Written informed consent will be recorded from every consented patient.

DISCUSSION

This study has the potential to improve the recovery of hospitalized patients by adding knowledge on the efficacy of acupressure therapy in this setting. A multipoint acupressure protocol will be compared to both a no intervention group and a light touch group, providing insight into different aspects of the placebo effect.

TRIAL REGISTRATION

ClinicalTrial.gov, NCT02762435 . Registered on 14 April 2016.

摘要

背景

穴位按压疗法可能有助于改善术后症状,如术后恶心呕吐(PONV)、疼痛和睡眠障碍,并提高术后恢复质量。本研究的主要目的是探讨穴位按压疗法对手术治疗后住院患者术后满意度和恢复质量的疗效。

方法/设计:这项三组平行、优效性、盲法、随机对照试验将检验以下假设:合谷穴(LI4)、内关穴(PC6)和神门穴(HT7)穴位按压联合应用在改善住院患者术后恢复质量方面优于假按压或无干预。至少150名患者将按1:1:1的比例随机分配到三个实验组之一:对照组(无访视)、轻触组(假穴位按压)或主动穴位按压疗法组。干预将每天进行3次,共2天。在随机分组后的3天内测量患者满意度、恢复质量、PONV和疼痛情况。该研究方案于2016年3月21日获得石溪大学机构审查委员会批准。将记录每位同意参与的患者的书面知情同意书。

讨论

本研究有可能通过增加穴位按压疗法在这种情况下的疗效知识来改善住院患者的恢复情况。将一种多点穴位按压方案与无干预组和轻触组进行比较,从而深入了解安慰剂效应的不同方面。

试验注册

ClinicalTrial.gov,NCT02762435。于2016年4月14日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0d2e/5341349/186f50d5d896/13063_2017_1839_Fig1_HTML.jpg

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