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

25 апреля 2016 г. обновлено: 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.

Обзор исследования

Статус

Неизвестный

Условия

Боль

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Ожидаемый)

Фаза

Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Канада
- Quebec
  - Montreal, Quebec, Канада, H3T 1E2
    - Рекрутинг
    - Jewish General Hospital
    - Контакт:
      
      Madalina Boitor, PhD (c)
      
      Электронная почта: madalina.boitor@mcgill.ca

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Основная цель: Уход
Распределение: Рандомизированный
Интервенционная модель: Параллельное назначение
Маскировка: Одинокий

Количество рук

Оружие и интервенции

Группа участников / Армия	Вмешательство/лечение
Экспериментальный: 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.	Другой: hand massage Другой: application of unscented hypoallergenic cream Другой: environmental adjustments
Активный компаратор: 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.	Другой: application of unscented hypoallergenic cream Другой: environmental adjustments Другой: hand holding
Другой: 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.	Другой: environmental adjustments

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
change in pain intensity from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale Временное ограничение: 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

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
change in pain unpleasantness from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale Временное ограничение: 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) Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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) Временное ограничение: 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) Временное ограничение: 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) Временное ограничение: 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) Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: immediately after each intervention and 30 minutes later within 24 hours postop		immediately after each intervention and 30 minutes later within 24 hours postop

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

McGill University

Следователи

Главный следователь: Celine Gelinas, PhD, McGill University

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 апреля 2016 г.

Первичное завершение (Ожидаемый)

1 апреля 2017 г.

Завершение исследования (Ожидаемый)

1 апреля 2017 г.

Даты регистрации исследования

Первый отправленный

3 февраля 2016 г.

Впервые представлено, что соответствует критериям контроля качества

5 февраля 2016 г.

Первый опубликованный (Оценивать)

10 февраля 2016 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

27 апреля 2016 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

25 апреля 2016 г.

Последняя проверка

1 апреля 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

15-186

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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