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

November 12, 2024 updated by: Oyku Kara, Istanbul University - Cerrahpasa (IUC)

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Sternotomy pain
Time Frame: Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
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
Time Frame: Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
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
Time Frame: Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
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
Time Frame: Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Systolic blood pressure
Time Frame: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Diastolic blood pressure
Time Frame: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Pulse rate
Time Frame: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Respiratory rate
Time Frame: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Oxygen saturation
Time Frame: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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