Effect of Swedish Hand Massage on Pain in Patients Undergoing CABG Surgery

Effect of Swedish Hand Massage on Pain in Patients Undergoing Coronary Artery Bypass Graft Surgery: Randomized Controlled Trial

Coronary Artery Bypass Grafting (CABG) surgery is performed commonly today. Heart surgery performed on more than two million individuals every year leads patients experience severe postoperative pain for causes such as cutting of intercostal nerves along the incision line, pleural irritation caused by thoracic catheters etc. Hand massage, which is one of the non-pharmacological methods, is an effective procedure that can be applied independently by nurses for pain management. The objective of this randomized controlled study is to investigate the effect of hand massage applied to the patients with CABG surgery during the postoperative intensive care process, on pain.

Study Overview

• Status: Completed
• Conditions: Pain; Pain Management; Massage; Nursing; Coronary Artery Bypass Graft Surgery (CABG); Hand Massage
• Intervention / Treatment: Other: Swedish Hand Massage

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Şişli
    • Istanbul, Şişli, Turkey
      • Istanbul University-Cerrahpaşa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who underwent CABG surgery,
• Stated that they were in pain,
• 18 years old and older,
• Had not completed 48 hours after the surgical procedure,
• Accepted to participate in the study verbally and in writing after being informed about the study,
• Could understand the information given,
• Could read, write and speak Turkish,
• Did not have any physiological, psychological or mental problems that would prevent verbal communication,
• Did not have any limb, vascular problem, wound or catheter that would prevent the application of hand massage,
• were ASA classified as I and II,
• Had no previous hand massage experience,
• Did not participate in any other clinical studies during the same period,
• Did not develop any complications during and after the surgical procedure,
• Physiological parameters were within normal limits during the surgical procedure,
• Received the same type of treatment in the post-surgical period,
• Body mass index was within normal limits

Exclusion Criteria:

• Patients who have complications during or after surgical intervention,
• Intubated,
• Have any limb, vascular problem, wound or catheter that prevents hand massage,
• Under the effect of pharmacological or non-pharmacological interventions that will affect pain,
• Obese (body mass index (BMI≥30),

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Swedish hand massage; Swedish hand massage was applied to patients who were extubated after the first 4 hours after surgery, were not under the effect of pharmacological or non-pharmacological analgesia, and were in the intensive care period after the first expression of pain.	Other: Swedish Hand Massage; Swedish technique hand massage: Effleurage-petrissage-friction-tapotement,-vibration-effleurage
No Intervention: Control; Patients who were extubated within the first 4 hours after surgery, who were not under the effect of pharmacological or nonpharmacological analgesia, and who were admitted to the intensive care unit with the first pain symptom were followed up during the follow-up periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sternotomy pain	Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
Drain pain	Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
Back Pain	Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
Leg incision pain	Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.

Secondary Outcome Measures

Outcome Measure	Time Frame
Systolic blood pressure	Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Diastolic blood pressure	Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Pulse rate	Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Respiratory rate	Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Oxygen saturation	Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Collaborators: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Estimated): November 14, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Nursing; Coronary Artery Bypass Graft; Swedish Massage; Hand Massage
• Other Study ID Numbers: 3435-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In order to protect the rights of patients, an undertaking was given to the Ethics Committee that the data would not be shared with anyone other than the researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No