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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05750524
Other study ID # 7074-GOA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 21, 2022
Est. completion date July 28, 2022

Study information

Verified date February 2023
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date July 28, 2022
Est. primary completion date July 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
reflexology hand massage
Reflexology massage methods applied randomly to both trial groups.
classical hand massage
Classical hand massage methods applied randomly to both trial groups.

Locations

Country Name City State
Turkey Ilkin Yilmaz Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 blood pressures of patients both reflexology and classical hand massage group 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
Secondary heart rate of patients both reflexology and classical hand massage group 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
Secondary respiratory frequency of patients both reflexology and classical hand massage group 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
Secondary tidal volume of patients both reflexology and classical hand massage group 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
Secondary peripheral oxygen saturation of patients both reflexology and classical hand massage group 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
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