Clinical trial NCT05750524: The Effect of Hand Massage on Endotracheal Suctioning Pain and Hemodynamic Parameters
Official title: The Effect of Hand Massage Applied With Two Different Methods on Endotracheal Suctioning Pain and Hemodynamic Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Aspiration
Pain
Reflexology
Massage
Hemodynamic Instability
Keywords: endotracheal suctioning
endotracheal aspiration
pain
hand massage
reflexology
hemodynamic parameters
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change from baseline pain level of patients at 5 minutes both reflexology and classical hand massage group
timeFrame: just before ETS and immediately after and 5th minute after ETS
Secondary outcomes:
measure: blood pressures of patients both reflexology and classical hand massage group
timeFrame: just before ETS and immediately after and 5th minute after ETS
measure: heart rate of patients both reflexology and classical hand massage group
timeFrame: just before ETS and immediately after and 5th minute after ETS
measure: respiratory frequency of patients both reflexology and classical hand massage group
timeFrame: just before ETS and immediately after and 5th minute after ETS
measure: tidal volume of patients both reflexology and classical hand massage group
timeFrame: just before ETS and immediately after and 5th minute after ETS
measure: peripheral oxygen saturation of patients both reflexology and classical hand massage group
timeFrame: just before ETS and immediately after and 5th minute after ETS
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ilkin Yilmaz
Study officials:
affiliation: Assist Prof
name: İlkin Yılmaz, PhD
role: STUDY_CHAIR
affiliation: Res Assis
name: Gizem Göktuna, PhDc
role: PRINCIPAL_INVESTIGATOR
affiliation: Assoc Prof
name: Gülşah Gürol Arslan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor
name: Dilek Özden, PhD
role: PRINCIPAL_INVESTIGATOR
References: