The Effect of Hand Massage on Endotracheal Suctioning Pain and Hemodynamic Parameters

February 28, 2023 updated by: Ilkin Yilmaz, Dokuz Eylul University

The Effect of Hand Massage Applied With Two Different Methods on Endotracheal Suctioning Pain and Hemodynamic Parameters

Endotracheal suctioning (ETS) is one of the most frequently applied care procedures in intensive care units in patients with artificial airway and mechanical ventilation. Suctioning, like all other invasive procedures, causes some complications. Various complications such as pain, hypoxemia, irregularity in blood pressure and heart rate, arrhythmia, increased respiratory frequency, and decreased respiratory depth may develop in patients. Pain is a physiological response that affects the patient's comfort and vital signs. hemodynamic parameters triggered by suctioning, as well as pain, may be positively affected by reflexology and classical hand massage.

Study Overview

Detailed Description

Endotracheal suctioning (ETS) is one of the most frequently applied care procedures in intensive care units in patients with artificial airway and mechanical ventilation. ETS is applied to patients for purposes such as ensuring airway opening in patients by removing secretions from the lungs, ensuring and maintaining optimal gas exchange.

Suctioning, like all other invasive procedures, causes some complications. Various complications such as pain, hypoxemia, irregularity in blood pressure and heart rate, arrhythmia, increased respiratory frequency, and decreased respiratory depth may develop in patients. In the literature, endotracheal suctioning has been reported as one of the most painful procedures reported by patients in the intensive care unit, regardless of the application technique. Pain is a physiological response that affects the patient's comfort and vital signs. In the literature, there are studies on music therapy to reduce or completely relieve the pain related to the suctioning procedure, but there are no studies applied with other alternative methods.

Classical hand massage and reflexology hand massage are included in complementary and supportive applications. It is stated that reflexology massage applied in studies on various patient groups is effective on many symptoms such as fatigue, pain, anxiety, sleep and cramps. There was no study finding that examined the effect of hand massage on suctioning pain and hemodynamic parameters during suctioning. It is thought that hand massage can be an effective intervention that nurses can apply independently in the management of pain during suctioning. It is thought that hemodynamic parameters triggered by suctioning, as well as pain, will be positively affected by reflexology and classical hand massage.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • 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

      • İzmir, Turkey, 35340
        • Ilkin Yilmaz

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 18 years old
  • Those who agreed to participate in the study
  • Orally intubated,
  • Receiving mechanical ventilator support,
  • No history of chronic pain (eg arthritis)
  • Not addicted to alcohol and drugs
  • Does not have a psychological problem (such as depression, anxiety disorder),
  • Not using anxiolytic, antidepressant or antipsychotic medication
  • The sedation-analgesic levels did not change during the study,
  • No additional sedation-analgesic medication is applied during the massage and suctioning applications,
  • Riker Sedation Agitation Scale score is 2-4 points,
  • Having no objections to massaging their hands (not having any skin lesions, burns, pathological diseases related to muscles and bones),
  • Patients who need suctioning within two hours at the latest after the end of the massage will be included in the sample.

Exclusion Criteria:

  • Being under the age of 18,
  • Having a Riker Sedation Agitation Scale score of 1, or 5 and above,
  • Changing sedation and analgesic doses during the study,
  • Having chronic disease pain,
  • Being addicted to alcohol and drugs,
  • Having a psychological problem and using antidepressant, anxiolytic or antipsychotic medication,
  • Discharged, exitus, extubated, tracheostomy or tracheostomy opened,
  • Having any skin lesions, burns, open wounds, pathological diseases related to muscles and bones on their hands,
  • Needing suctioning during the massage application,
  • Not needing suctioning within the first two hours after the massage application is finished,
  • Patients who require suctioning within one hour after the first suctioning procedure performed between 08:00-20:00 will be excluded from the study.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: reflexology
In the reflexology group, reflexology hand massage applied between two suctioning period
Reflexology massage methods applied randomly to both trial groups.
Placebo Comparator: classical massage
In the classical massage group, classical hand massage applied between two suctioning period
Classical hand massage methods applied randomly to both trial groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline pain level of patients at 5 minutes both reflexology and classical hand massage group
Time Frame: just before ETS and immediately after and 5th minute after ETS
pain level (point) was measured via Critical-care Pain Observation Tool just before ETS and immediately after and 5th minute after ETS before and after massages
just before ETS and immediately after and 5th minute after ETS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressures of patients both reflexology and classical hand massage group
Time Frame: just before ETS and immediately after and 5th minute after ETS
systolic and diastolic blood pressure (mmHg) were measured just before ETS and immediately after and 5th minute after ETS before and after massages
just before ETS and immediately after and 5th minute after ETS
heart rate of patients both reflexology and classical hand massage group
Time Frame: just before ETS and immediately after and 5th minute after ETS
heart rate (heart rate/minute) was measured just before ETS and immediately after and 5th minute after ETS before and after massages
just before ETS and immediately after and 5th minute after ETS
respiratory frequency of patients both reflexology and classical hand massage group
Time Frame: just before ETS and immediately after and 5th minute after ETS
respiratory frequency (respiratory frequency/minute) measured just before ETS and immediately after and 5th minute after ETS before and after massages
just before ETS and immediately after and 5th minute after ETS
tidal volume of patients both reflexology and classical hand massage group
Time Frame: just before ETS and immediately after and 5th minute after ETS
tidal volume (ml) was measured just before ETS and immediately after and 5th minute after ETS before and after massages
just before ETS and immediately after and 5th minute after ETS
peripheral oxygen saturation of patients both reflexology and classical hand massage group
Time Frame: just before ETS and immediately after and 5th minute after ETS
peripheral oxygen saturation (%) measured just before ETS and immediately after and 5th minute after ETS before and after massages
just before ETS and immediately after and 5th minute after ETS

Collaborators and Investigators

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

Investigators

  • Study Chair: İlkin Yılmaz, PhD, Assist Prof
  • Principal Investigator: Gizem Göktuna, PhDc, Res Assis
  • Principal Investigator: Gülşah Gürol Arslan, PhD, Assoc Prof
  • Principal Investigator: Dilek Özden, PhD, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

June 21, 2022

Primary Completion (Actual)

July 28, 2022

Study Completion (Actual)

July 28, 2022

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We cannot share participant data due to Turkish Personal Data Protection Law no. 6698

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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