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

Primary Purpose

Pain

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
hand massage
hand holding
application of unscented hypoallergenic cream
environmental adjustments
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, thoracic surgery, massage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Jewish General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

hand massage

hand holding

rest group

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

change in pain unpleasantness from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
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.
change in anxiety from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
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
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
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
pain interference as assessed using the Brief Pain Inventory
change in pain intensity from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
change in pain unpleasantness from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
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)
change in anxiety from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
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
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
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

Full Information

First Posted
February 3, 2016
Last Updated
April 25, 2016
Sponsor
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT02679534
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
pain, thoracic surgery, massage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hand massage
Arm Type
Experimental
Arm 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.
Arm Title
hand holding
Arm Type
Active Comparator
Arm 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.
Arm Title
rest group
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
hand massage
Intervention Type
Other
Intervention Name(s)
hand holding
Intervention Type
Other
Intervention Name(s)
application of unscented hypoallergenic cream
Intervention Type
Other
Intervention Name(s)
environmental adjustments
Primary Outcome Measure Information:
Title
change in pain intensity from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
Description
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.
Time Frame
before and immediately after each intervention within 24 hours postoperatively
Secondary Outcome Measure Information:
Title
change in pain unpleasantness from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
Time Frame
before and immediately after each intervention within 24 hours postop
Title
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)
Description
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.
Time Frame
before and immediately after each intervention within 24 hours postop
Title
change in anxiety from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
Time Frame
before and immediately after each intervention within 24 hours postop
Title
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
Time Frame
before and immediately after each intervention within 24 hours postop
Title
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
Time Frame
before and immediately after each intervention within 24 hours postop
Title
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
Time Frame
before and immediately after each intervention within 24 hours postop
Title
pain interference as assessed using the Brief Pain Inventory
Time Frame
on the second and fourth postoperative days
Title
change in pain intensity from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
Time Frame
immediately after each intervention and 30 minutes later within 24 hours postop
Title
change in pain unpleasantness from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
Time Frame
immediately after each intervention and 30 minutes later within 24 hours postop
Title
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)
Time Frame
immediately after each intervention and 30 minutes later within 24 hours postop
Title
change in anxiety from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)
Time Frame
immediately after each intervention and 30 minutes later within 24 hours postop
Title
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
Time Frame
immediately after each intervention and 30 minutes later within 24 hours postop
Title
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
Time Frame
immediately after each intervention and 30 minutes later within 24 hours postop
Title
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
Time Frame
immediately after each intervention and 30 minutes later within 24 hours postop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madalina Boitor, PhD(C)
Email
madalina.boitor@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celine Gelinas, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madalina Boitor, PhD (c)
Email
madalina.boitor@mcgill.ca

12. IPD Sharing Statement

Citations:
PubMed Identifier
23269131
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.
Results Reference
background
PubMed Identifier
20347836
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.
Results Reference
background
PubMed Identifier
22964355
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.
Results Reference
background
PubMed Identifier
27821384
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.
Results Reference
derived

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

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