Dataset Information

Implementation of music in the perioperative standard care of colorectal surgery: study protocol of the IMPROVE Study.

ABSTRACT:

Introduction

Perioperative music intervention has been proven effective in reducing anxiety, pain, neurohormonal stress response and medication requirement. Unfortunately, there is a gap between new effective interventions and their (interventions) integration in standard care protocols. The aim of this preimplementation and postimplementation study is to investigate the adherence to a music intervention in a tailored, multilevel, systematic implementation strategy and the initial impact of the implementation on postoperative pain in patients undergoing colorectal surgery.

Methods and design

A monocentre prospective preimplementation and postimplementation study was set up using The Consolidated Framework for Implementation Research to conduct a systematic implementation of music intervention in three phases. Primary outcomes are adherence to the music intervention and the initial impact of the music intervention implementation on postoperative pain scores on the first postoperative day. At least 100 patients will be included in the study. Secondary outcomes include adherence to the implementation strategy, penetration of music intervention in the standard care, assessment of the determinants for implementation, impact of the implemented music intervention on pain during the entire admission, anxiety, medication usage, complications, hospital and intensive care unit (ICU) length of stay.

Ethics and dissemination

The Medical Ethics Review Board of Erasmus MC University Medical Centre Rotterdam, The Netherlands, has approved this protocol. The study is being conducted in accordance with the Declaration of Helsinki. Results of this trial will be published in peer-reviewed scientific journals and conference presentations.

Trial registration

Dutch Trial Register NL8071.

SUBMITTER: Kakar E

PROVIDER: S-EPMC8557300 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Publications

Implementation of music in the perioperative standard care of colorectal surgery: study protocol of the IMPROVE Study.

Kakar Ellaha E Ista Erwin E Klimek M M Jeekel Johannes J

BMJ open 20211028 10

<h4>Introduction</h4>Perioperative music intervention has been proven effective in reducing anxiety, pain, neurohormonal stress response and medication requirement. Unfortunately, there is a gap between new effective interventions and their (interventions) integration in standard care protocols. The aim of this preimplementation and postimplementation study is to investigate the adherence to a music intervention in a tailored, multilevel, systematic implementation strategy and the initial impact ...[more]

PMID: 34711596

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Project description:IntroductionThe enhanced recovery after surgery (ERAS) protocol provides optimised care guidelines for patients undergoing elective colorectal surgery. To ensure high compliance with active ERAS elements, patients must be educated to actively participate in the perioperative care pathway. Mobile health is a rapidly expanding area of the digital health sector that is effective in educating and engaging patients during follow-up. iColon is a mobile application designed by the Operative Unit of General Surgery of IRCCS Sacro Cuore Don Calabria Hospital of Negrar of Valpolicella, which is specifically targeted at patients undergoing elective colorectal surgery. iColon is organised into ERAS phases, and it provides real-time feedback to surgeons about a patient's adherence to perioperative active ERAS elements.Methods and analysisWe hypothesise that by providing a patient-focused mobile application, compliance with active ERAS elements could be improved.The first coprimary objective is to build patient confidence in using the mobile application, iColon, during perioperative care. The second coprimary objective is to establish patient compliance with active ERAS elements.Secondary objectives include examining: length of stay, 30-day readmission rate, postoperative complications and patient satisfaction of received care.This study is a prospective observational real-world study of patients undergoing elective colorectal surgery who are following the ERAS protocol and using iColon during perioperative periods between September 2020 and December 2022.By educating and engaging patients in the ERAS protocol, the mobile application, iColon, should stimulate patients to be more proactive in managing their healthcare by complying more closely with active ERAS elements.Ethics and disseminationThis study has been approved by the local Ethics Committee with the protocol number 29219 of 25 May 2020. The results will be actively disseminated through peer-reviewed journals, conference presentations and various community engagement activities.

Project description:BackgroundValvular heart diseases are frequent and increasing in prevalence. Minimally invasive heart valve surgery embedded in an interdisciplinary enhanced recovery after surgery (ERAS) program may have potential benefits with regard to reduced length of stay and improved patient reported outcomes. However, no prospective randomized data exist regarding the superiority of ERAS program for the patients' outcome.MethodsWe aim to randomize (1:1) a total of 186 eligible patients with minimally invasive heart valve surgery to an ERAS program vs. standard treatment at two centers including the University Medical Center Hamburg-Eppendorf, Germany, and the University Hospital Augsburg, Germany. The intervention is composed out of pre-, peri-, and postoperative components. The preoperative protocol aims at better preparation for the operation with regard to physical activity, nutrition, and psychological preparedness. Intraoperative anesthesiologic and surgical management are trimmed to enable an early extubation. Patients will be transferred to a specialized postoperative anesthesia care unit, where first mobilization occurs 3 h after surgery. Transfer to low care ward will be at the next day and discharge at the fifth day. Participants in the control group will receive treatment as usual. Primary endpoints include functional discharge at discharge and duration of in-hospital care during the first 12 months after index surgery. Secondary outcomes include health-related quality of life, health literacy, and level of physical activity.DiscussionThis is the first randomized controlled trial evaluating the effectiveness of an ERAS process after minimally invasive heart valve surgery. Interprofessional approach is the key factor of the ERAS process and includes in particular surgical, anesthesiological, physiotherapeutic, advanced nursing, and psychosocial components. A clinical implication guideline will be developed facilitating the adoption of ERAS model in other heart teams.Trial registrationThe study has been registered in ClinicalTrials.gov ( NCT04977362 assigned July 27, 2021).

Project description:BackgroundPhotoplethysmography with a digital sensor (ClearSight, Edwards Lifesciences, Irvine, CA, USA) connected to a dedicated monitor (EV 1000, Edwards Lifesciences) was recently proposed for use in performing hemodynamic optimization during surgery. The objective of this study is to evaluate the effect of photoplethysmography on the incidence of postoperative complications compared with the conventional hemodynamic algorithm, which uses mean arterial pressure.Methods/designThe hemodynamic optimization using photoplethysmography (PANEX3) trial is a monocentric, randomized, single-blind, controlled, two parallel arm, superiority trial, randomizing 160 patients with an intermediate risk of postoperative complications after colorectal surgery. Informed consent will be obtained from all participants. The hemodynamic optimization is conducted using a specified hemodynamic algorithm either with photoplethysmography (the photoplethysmography group) or with conventional mean arterial pressure (the control group). The anesthesiologist performed a 1:1 randomization the day before surgery using a scratch card, which is available 24/7. The randomization sequence is generated using permutated blocks. Both the patients and surgeons are blinded to the allocation group. The primary outcome is the incidence of at least one postoperative complication during the 30 days following surgery. Two independent experts, who were blinded to the group allocations, validate the complication for each patient using an a priori classification. The secondary outcomes are to study the total number of postoperative complications, the real length of hospital stays, and the postoperative mortality between each group.DiscussionThe PANEX3 trial is the first randomized controlled study conducted to investigate whether perioperative hemodynamic optimization using photoplethysmography during colorectal surgery could decrease the incidence of patients having at least one postoperative complication.Trial registrationClinicalTrials.gov Identifier: NCT02343601.

Dataset Information

Implementation of music in the perioperative standard care of colorectal surgery: study protocol of the IMPROVE Study.

Introduction

Methods and design

Ethics and dissemination

Trial registration

Publications

Implementation of music in the perioperative standard care of colorectal surgery: study protocol of the IMPROVE Study.

Similar Datasets

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