NCT06688617

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 12, 2024

Last Update Submit

November 12, 2024

Conditions

Keywords

Coronary Artery Bypass GraftHand MassageSwedish MassagePainNursing

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • 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.

Study Arms (2)

Swedish hand massage

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Swedish technique hand massage: Effleurage-petrissage-friction-tapotement,-vibration-effleurage

Swedish hand massage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent CABG surgery,
  • Stated that they were in pain,
  • 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,
  • +1 more criteria

You may not qualify if:

  • 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),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Şişli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 14, 2024

Study Start

April 30, 2018

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

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.

Locations