The Effectiveness of Hand Massage on Pain in Critically Ill Patients After Cardiac Surgery: A Randomized Controlled Trial Protocol

Background: Postoperative pain is common in the intensive care unit despite the administration of analgesia. Some trials suggest that massage can be effective at reducing postoperative pain in acute care units; however, its effects on pain relief in the intensive care unit and when pain severity is highest remain unknown. Objective: The objective is to evaluate the effectiveness of hand massage on the pain intensity (primary outcome), unpleasantness and interference, muscle tension, anxiety, and vital signs of critically ill patients after cardiac surgery. Methods: A 3-arm randomized controlled trial will be conducted. A total of 79 patients who are 18 years or older, able to speak French or English and self-report symptoms, have undergone elective cardiac surgery, and do not have a high risk of postoperative complications and contraindications to hand massage will be recruited. They will be randomly allocated (1:1:1) to standard care plus either 3 20-minute hand massages (experimental), 3 20-minute hand holdings (active control), or 3 20-minute rest periods (passive control). Pain intensity, unpleasantness, anxiety, muscle tension, and vital signs will be evaluated before, immediately after, and 30 minutes later for each intervention administered within 24 hours postoperatively. Peer-reviewed competitive funding was received from the Quebec Nursing Intervention Research Network and McGill University in December 2015, and research ethics approval was obtained February 2016. Results: Recruitment started in April 2016, and data collection is expected to be complete by January 2017. To date, 24 patients were randomized and had data collection done. Conclusions: This study will be one of the first randomized controlled trials to examine the effect of hand massage on the pain levels of critically ill patients after cardiac surgery and to provide empirical evidence for the use of massage among this population. ClinicalTrial: ClinicalTrials.gov NCT02679534; https://clinicaltrials.gov/ct2/show/NCT02679534 (Archived by WebCite at http://www.webcitation.org/6l8Ly5eHS) [JMIR Res Protoc 2016;5(4):e203]