Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

25 kwietnia 2016 zaktualizowane przez: 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.

Przegląd badań

Status

Nieznany

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

76

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: hand massage
Inny: application of unscented hypoallergenic cream
Inny: environmental adjustments
Aktywny komparator: 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.
Inny: application of unscented hypoallergenic cream
Inny: environmental adjustments
Inny: hand holding
Inny: 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.
Inny: environmental adjustments

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
change in pain intensity from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
change in pain unpleasantness from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: immediately after each intervention and 30 minutes later within 24 hours postop
immediately after each intervention and 30 minutes later within 24 hours postop

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

McGill University

Śledczy

  • Główny śledczy: Celine Gelinas, PhD, McGill University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 kwietnia 2016

Zakończenie podstawowe (Oczekiwany)

1 kwietnia 2017

Ukończenie studiów (Oczekiwany)

1 kwietnia 2017

Daty rejestracji na studia

Pierwszy przesłany

3 lutego 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 lutego 2016

Pierwszy wysłany (Oszacować)

10 lutego 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

27 kwietnia 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 kwietnia 2016

Ostatnia weryfikacja

1 kwietnia 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 15-186

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Ból

Badania kliniczne na hand massage

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Ireland

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj