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

25 avril 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

76

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: hand massage
Autre: application of unscented hypoallergenic cream
Autre: environmental adjustments
Comparateur actif: 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.
Autre: application of unscented hypoallergenic cream
Autre: environmental adjustments
Autre: hand holding
Autre: 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.
Autre: environmental adjustments

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
change in pain intensity from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
change in pain unpleasantness from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: immediately after each intervention and 30 minutes later within 24 hours postop
immediately after each intervention and 30 minutes later within 24 hours postop

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

McGill University

Les enquêteurs

  • Chercheur principal: Celine Gelinas, PhD, McGill University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2016

Achèvement primaire (Anticipé)

1 avril 2017

Achèvement de l'étude (Anticipé)

1 avril 2017

Dates d'inscription aux études

Première soumission

3 février 2016

Première soumission répondant aux critères de contrôle qualité

5 février 2016

Première publication (Estimation)

10 février 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

27 avril 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 avril 2016

Dernière vérification

1 avril 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 15-186

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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