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Completed

NCT Number: NCT05750524

The Effect of Hand Massage 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ilkin Yilmaz

Izmir, 35340, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

reflexology hand massage

Other

Reflexology massage methods applied randomly to both trial groups.

classical hand massage

Other

Classical hand massage methods applied randomly to both trial groups.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 1, 2023
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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