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

NCT05750524 | Completed

• 1 other identifier: 7074-GOA
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endotracheal Aspiration; Pain; Reflexology; Massage; Hemodynamic Instability

Keywords

endotracheal suctioning; endotracheal aspiration; pain; hand massage; reflexology; hemodynamic parameters

Outcome Measures

Primary Outcomes (1)

• change from baseline pain level of patients at 5 minutes both reflexology and classical hand massage group

  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 Outcomes (5)

• blood pressures of patients both reflexology and classical hand massage group

  just before ETS and immediately after and 5th minute after ETS

• heart rate of patients both reflexology and classical hand massage group

  just before ETS and immediately after and 5th minute after ETS

• respiratory frequency of patients both reflexology and classical hand massage group

  just before ETS and immediately after and 5th minute after ETS

• tidal volume of patients both reflexology and classical hand massage group

  just before ETS and immediately after and 5th minute after ETS

• peripheral oxygen saturation of patients both reflexology and classical hand massage group

  just before ETS and immediately after and 5th minute after ETS

Study Arms (2)

reflexology

EXPERIMENTAL

In the reflexology group, reflexology hand massage applied between two suctioning period

Other: reflexology hand massage

classical massage

PLACEBO COMPARATOR

In the classical massage group, classical hand massage applied between two suctioning period

Other: classical hand massage

Interventions

reflexology hand massage OTHER

Reflexology massage methods applied randomly to both trial groups.

reflexology

classical hand massage OTHER

Classical hand massage methods applied randomly to both trial groups.

classical massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Ilkin Yilmaz

Izmir, 35340, Turkey (Türkiye)

Location

Related Links

• Yaman Aktaş, Y., \& Karabulut, N. (2016). The effects of music therapy in endotracheal suctioning of mechanically ventilated patients. Nursing in Critical Care, 21(1), 44-52.
• Acikgoz, A., \& Yildiz, S. (2015). Effects of Open and Closed Suctioning Systems on Pain in Newborns Treated with Mechanical Ventilation. Immunology and Allergy Clinics of North America, 35(4), 653-663.
• Wang, H. L., \& Keck, J. F. (2004). Foot and hand massage as an intervention for postoperative pain. Pain Management Nursing, 5(2), 59-65.
• Özden, D., \& Görgülü, R. S. (2015). Effects of open and closed suction systems on the haemodynamic parameters in cardiac surgery patients. Nursing in Critical Care, 20(3), 118-125.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• İlkin Yılmaz, PhD

  Assist Prof

  STUDY CHAIR

• Gizem Göktuna, PhDc

  Res Assis

  PRINCIPAL INVESTIGATOR

• Gülşah Gürol Arslan, PhD

  Assoc Prof

  PRINCIPAL INVESTIGATOR

• Dilek Özden, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients and the investigator doing the suctioning and assessing the patient's pain and vital signs will be masked.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof., Ph.D.

Model Details: In the AB trial group, reflexology hand massage will be applied on the first day, classical hand massage on the second day, and in the BA group classical hand massage on the first day and reflexology hand massage on the second day will be applied.

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: March 1, 2023
• Study Start: June 21, 2022
• Primary Completion: July 28, 2022
• Study Completion: July 28, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)