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

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McGill University

Status

Unknown

Conditions

Pain

Treatments

Other: hand holding
Other: hand massage
Other: environmental adjustments
Other: application of unscented hypoallergenic cream

Study type

Interventional

Funder types

Other

Identifiers

NCT02679534
15-186

Details and patient eligibility

About

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.

Enrollment

76 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

76 participants in 3 patient groups

hand massage
Experimental group
Description:
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.
Treatment:
Other: application of unscented hypoallergenic cream
Other: environmental adjustments
Other: hand massage
hand holding
Active Comparator group
Description:
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.
Treatment:
Other: application of unscented hypoallergenic cream
Other: environmental adjustments
Other: hand holding
rest group
Other group
Description:
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.
Treatment:
Other: environmental adjustments

Trial contacts and locations

1

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Central trial contact

Madalina Boitor, PhD(C)

Data sourced from clinicaltrials.gov

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