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

NCT ID: NCT05750524

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-21

Study Completion Date

2022-07-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endotracheal Aspiration Pain Reflexology Massage Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Patients and the investigator doing the suctioning and assessing the patient's pain and vital signs will be masked.

Study Groups

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reflexology

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

Group Type EXPERIMENTAL

reflexology hand massage

Intervention Type OTHER

Reflexology massage methods applied randomly to both trial groups.

classical massage

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

Group Type PLACEBO_COMPARATOR

classical hand massage

Intervention Type OTHER

Classical hand massage methods applied randomly to both trial groups.

Interventions

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reflexology hand massage

Reflexology massage methods applied randomly to both trial groups.

Intervention Type OTHER

classical hand massage

Classical hand massage methods applied randomly to both trial groups.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Ilkin Yilmaz

Assist Prof., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İlkin Yılmaz, PhD

Role: STUDY_CHAIR

Assist Prof

Gizem Göktuna, PhDc

Role: PRINCIPAL_INVESTIGATOR

Res Assis

Gülşah Gürol Arslan, PhD

Role: PRINCIPAL_INVESTIGATOR

Assoc Prof

Dilek Özden, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Ilkin Yilmaz

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/25721305/

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.

https://doi.org/10.1016/j.pmn.2015.01.002

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.

https://doi.org/10.1016/j.pmn.2004.01.002

Wang, H. L., \& Keck, J. F. (2004). Foot and hand massage as an intervention for postoperative pain. Pain Management Nursing, 5(2), 59-65.

https://pubmed.ncbi.nlm.nih.gov/24991700/

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.

Other Identifiers

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7074-GOA

Identifier Type: -

Identifier Source: org_study_id

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