이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

The Effectiveness of Hand Massage on the Pain of Cardiac Surgery Critically Ill

2016년 4월 25일 업데이트: Céline Gélinas, McGill University

The Effectiveness of Hand Massage on the Pain of Cardiac Surgery Critically Ill- A Randomized Controlled Trial

Postoperative pain is a common phenomenon in the intensive care unit (ICU) despite the multitude of efforts dedicated to promote its effective relief. Mounting evidence shows that cardiac surgery ICU patients experience moderate to severe pain reaching proportions as high as 74% despite the use of analgesics. The highest pain intensity is experienced in the first 24 hours post surgery when patients are still in the ICU, and represents a strong predictor for the presence and severity of persistent postoperative pain. To maximize pain relief, massage has been suggested in the recent clinical practice guidelines of the Society of Critical-Care Medicine as a complementary non-pharmacological therapy in the ICU given its opioid-sparing and analgesia-enhancing potential. Some randomized controlled trials showed promising pain relief effects of massage when administered to cardiac surgery patients in acute care units, however, its effects on pain relief while patients are still in the ICU and when pain severity is highest remain unknown.

This study aims to compare the effect of three 20-minute hand massage administrations within 24 hours postop on the pain intensity (primary outcome), pain unpleasantness, pain interference, muscle tension, anxiety and vital signs (blood pressure, heart and respiratory rates) of adult intensive care unit (ICU) patients post cardiac surgery versus hand holding (i.e., simple touch) and standard care. Other objectives are to describe the location and quality of pain of cardiac surgery ICU patients.

Hypothesis:

Patients receiving 3 hand massages within 24 hours postop will have lower pain intensity, unpleasantness and interference, muscle tension, anxiety and vital signs compared to patients receiving hand holding and to those in the standard care group.

연구 개요

상태

알려지지 않은

정황

통증

개입 / 치료

연구 유형

중재적

등록 (예상)

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

캐나다
- Quebec
  - Montreal, Quebec, 캐나다, H3T 1E2
    - 모병
    - Jewish General Hospital
    - 연락하다:
      
      Madalina Boitor, PhD (c)
      
      이메일: madalina.boitor@mcgill.ca

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

able to speak French or English
elective cardiac surgery requiring sternal incision (e.g., coronary artery bypass graft, valve replacement)
able to answer questions and self-report symptoms

Exclusion Criteria:

previous cardiac surgery
diagnostic of cognitive or psychiatric disorder
pulmonary artery pressure >50 mmHg
right ventricular failure
systolic left ventricular dysfunction (ejection fraction 35% or less)
body mass index > 30
prolonged bleeding from the chest drainage tubes (i.e., >200 ml/h)
having mechanical blood pressure support (e.g., intra-aortic balloon pump)
receiving cardiac pacing with complete control of HR
peripheral intravenous line in the hands
suppurating/infective/inflammatory skin condition of the hands
hypersensitivity to touch.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 하나의

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
실험적: hand massage Patients will receive a 20 minute hand massage by a trained nurse in addition to the standard ICU care. Before administering the massage, a favorable environment will be created that promotes calmness such as dampening the light, reducing the alarm intensity, closing the curtains and the door and posting the notice "do not disturb", and a comfortable positioning of the patient will be ensured. The interventionist will hold each hand for 5-10 seconds, and apply 5-10 ml of unscented hypoallergenic cream to both hands and wrists. Then, she will perform massage using moderate pressure, and the stroking and kneading techniques during ten minutes on the palm and back of each hand.	다른: hand massage 다른: application of unscented hypoallergenic cream 다른: environmental adjustments
활성 비교기: hand holding The active control group will receive hand holding by the same trained nurse in addition to standard ICU care. The same hand hygiene and environmental adjustments will be made as for those receiving massage. Patients will have their hands held for 5-10 seconds and unscented hypoallergenic cream applied to both hands. Then, the interventionist will hold each of the patients' hand in her hand for ten minutes without performing any tissue manipulation. The hand holding procedure will last for a total of 20 minutes.	다른: application of unscented hypoallergenic cream 다른: environmental adjustments 다른: hand holding
다른: rest group The passive control group will have a 20 minutes rest period including the same environmental adjustments as the massage and hand holding groups in addition to the standard care administered in the ICU. The standard care includes the pharmacological and non-pharmacological treatments used to promote recovery and symptom relief. In the study ICU, cardiac surgery patients are automatically prescribed a pain management protocol that includes the regular administration of morphine, unless extraordinary patient circumstances require different prescriptions. Patients might equally receive breakthrough doses of analgesia in addition to regular opioids. Of the existing non-pharmacological interventions, repositioning and back rubs are commonly employed in the study ICU to provide patient comfort.	다른: environmental adjustments

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
change in pain intensity from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale 기간: before and immediately after each intervention within 24 hours postoperatively	Pain intensity will be captured using the 0 to 10 Numeric Rating Scale score, and the analysis metric will be the change in pain intensity from baseline (pre-intervention) to immediately after each intervention. For each study group, means and standard deviations of patients' pain intensity levels will be reported. Change in pain intensity levels will be assessed for each of the three interventions administered within 24 hours postop.	before and immediately after each intervention within 24 hours postoperatively

2차 결과 측정

결과 측정	측정값 설명	기간
change in pain unpleasantness from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale 기간: before and immediately after each intervention within 24 hours postop		before and immediately after each intervention within 24 hours postop
change in muscle tension from pre- to post-intervention by performing passive flexion and extension of patient's arm, and scoring 0 (relaxed), 1 (tense) or 2 (very tense/rigid) 기간: before and immediately after each intervention within 24 hours postop	The muscle tension ordinal scale 0-2 is based on the muscle tension item of the Critical-Care Pain Observation Tool, a behavioral pain scale for the assessment of pain in the non-verbal critically ill.	before and immediately after each intervention within 24 hours postop
change in anxiety from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale 기간: before and immediately after each intervention within 24 hours postop		before and immediately after each intervention within 24 hours postop
changes in 1-minute blood pressure average from pre- to post-intervention as assessed using a data collection computer connected to patient's bedside monitor 기간: before and immediately after each intervention within 24 hours postop		before and immediately after each intervention within 24 hours postop
changes in 1-minute heart rate average from pre- to post-intervention as assessed using a data collection computer connected to patient's bedside monitor 기간: before and immediately after each intervention within 24 hours postop		before and immediately after each intervention within 24 hours postop
changes in 1-minute respiratory rate average from pre- to post-intervention as assessed using a data collection computer connected to patient's bedside monitor 기간: before and immediately after each intervention within 24 hours postop		before and immediately after each intervention within 24 hours postop
pain interference as assessed using the Brief Pain Inventory 기간: on the second and fourth postoperative days		on the second and fourth postoperative days
change in pain intensity from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect) 기간: immediately after each intervention and 30 minutes later within 24 hours postop		immediately after each intervention and 30 minutes later within 24 hours postop
change in pain unpleasantness from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect) 기간: immediately after each intervention and 30 minutes later within 24 hours postop		immediately after each intervention and 30 minutes later within 24 hours postop
change in muscle tension from post-intervention to 30 minutes later by performing passive flexion and extension of patient's arm, and scoring 0 (relaxed), 1 (tense) or 2 (very tense/rigid) 기간: immediately after each intervention and 30 minutes later within 24 hours postop		immediately after each intervention and 30 minutes later within 24 hours postop
change in anxiety from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect) 기간: immediately after each intervention and 30 minutes later within 24 hours postop		immediately after each intervention and 30 minutes later within 24 hours postop
changes in 1-minute blood pressure average from post-intervention to 30 minutes later as assessed using a data collection computer connected to patient's bedside monitor 기간: immediately after each intervention and 30 minutes later within 24 hours postop		immediately after each intervention and 30 minutes later within 24 hours postop
changes in 1-minute heart rate average from post-intervention to 30 minutes later as assessed using a data collection computer connected to patient's bedside monitor 기간: immediately after each intervention and 30 minutes later within 24 hours postop		immediately after each intervention and 30 minutes later within 24 hours postop
changes in 1-minute respiratory rate average from post-intervention to 30 minutes later as assessed using a data collection computer connected to patient's bedside monitor 기간: immediately after each intervention and 30 minutes later within 24 hours postop		immediately after each intervention and 30 minutes later within 24 hours postop

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

McGill University

수사관

수석 연구원: Celine Gelinas, PhD, McGIll University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2016년 4월 1일

기본 완료 (예상)

2017년 4월 1일

연구 완료 (예상)

2017년 4월 1일

연구 등록 날짜

최초 제출

2016년 2월 3일

QC 기준을 충족하는 최초 제출

2016년 2월 5일

처음 게시됨 (추정)

2016년 2월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 4월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 4월 25일

마지막으로 확인됨

2016년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

15-186

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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The Effectiveness of Hand Massage on the Pain of Cardiac Surgery Critically Ill