Clinical trial NCT02679534: The Effectiveness of Hand Massage on the Pain of Cardiac Surgery Critically Ill
Official title: The Effectiveness of Hand Massage on the Pain of Cardiac Surgery Critically Ill- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: pain
thoracic surgery
massage
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: change in pain intensity from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
timeFrame: before and immediately after each intervention within 24 hours postoperatively
Secondary outcomes:
measure: change in pain unpleasantness from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
timeFrame: before and immediately after each intervention within 24 hours postop
measure: 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)
timeFrame: before and immediately after each intervention within 24 hours postop
measure: change in anxiety from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
timeFrame: before and immediately after each intervention within 24 hours postop
measure: 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
timeFrame: before and immediately after each intervention within 24 hours postop
measure: 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
timeFrame: before and immediately after each intervention within 24 hours postop
measure: 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
timeFrame: before and immediately after each intervention within 24 hours postop
measure: pain interference as assessed using the Brief Pain Inventory
timeFrame: on the second and fourth postoperative days
measure: change in pain intensity from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
timeFrame: immediately after each intervention and 30 minutes later within 24 hours postop
measure: change in pain unpleasantness from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
timeFrame: immediately after each intervention and 30 minutes later within 24 hours postop
measure: 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)
timeFrame: immediately after each intervention and 30 minutes later within 24 hours postop
measure: change in anxiety from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
timeFrame: immediately after each intervention and 30 minutes later within 24 hours postop
measure: 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
timeFrame: immediately after each intervention and 30 minutes later within 24 hours postop
measure: 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
timeFrame: immediately after each intervention and 30 minutes later within 24 hours postop
measure: 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
timeFrame: immediately after each intervention and 30 minutes later within 24 hours postop
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: McGill University
name: Celine Gelinas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
citation: Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.
citation: Braun LA, Stanguts C, Casanelia L, Spitzer O, Paul E, Vardaxis NJ, Rosenfeldt F. Massage therapy for cardiac surgery patients--a randomized trial. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1453-9, 1459.e1. doi: 10.1016/j.jtcvs.2012.04.027. Epub 2012 Sep 7.
citation: Boitor M, Martorella G, Laizner AM, Maheu C, Gelinas C. The Effectiveness of Hand Massage on Pain in Critically Ill Patients After Cardiac Surgery: A Randomized Controlled Trial Protocol. JMIR Res Protoc. 2016 Nov 7;5(4):e203. doi: 10.2196/resprot.6277.