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

Pain Clinical Trial

Official title:

The Effectiveness of Hand Massage on the Pain of Cardiac Surgery Critically Ill- A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02679534
• Other study ID #: 15-186
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2016
• Last updated: April 25, 2016
• Start date: April 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2016
• Source: McGill University
• Contact: Madalina Boitor, PhD(C)
• Email: madalina.boitor[@]mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Pain

Intervention

Other:
• hand massage

• hand holding

• application of unscented hypoallergenic cream

• environmental adjustments

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Barr J, Fraser GL, Puntillo K, Ely EW, Gélinas 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in pain intensity from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale	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	No
Secondary	change in pain unpleasantness from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale		before and immediately after each intervention within 24 hours postop	No
Secondary	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)	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	No
Secondary	change in anxiety from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale		before and immediately after each intervention within 24 hours postop	No
Secondary	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		before and immediately after each intervention within 24 hours postop	No
Secondary	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		before and immediately after each intervention within 24 hours postop	No
Secondary	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		before and immediately after each intervention within 24 hours postop	No
Secondary	pain interference as assessed using the Brief Pain Inventory		on the second and fourth postoperative days	No
Secondary	change in pain intensity from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)		immediately after each intervention and 30 minutes later within 24 hours postop	No
Secondary	change in pain unpleasantness from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)		immediately after each intervention and 30 minutes later within 24 hours postop	No
Secondary	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)		immediately after each intervention and 30 minutes later within 24 hours postop	No
Secondary	change in anxiety from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)		immediately after each intervention and 30 minutes later within 24 hours postop	No
Secondary	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		immediately after each intervention and 30 minutes later within 24 hours postop	No
Secondary	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		immediately after each intervention and 30 minutes later within 24 hours postop	No
Secondary	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		immediately after each intervention and 30 minutes later within 24 hours postop	No