- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05750524
The Effect of Hand Massage on Endotracheal Suctioning Pain and Hemodynamic Parameters
The Effect of Hand Massage Applied With Two Different Methods on Endotracheal Suctioning Pain and Hemodynamic Parameters
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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İzmir, Turkey, 35340
- Ilkin Yilmaz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: reflexology
In the reflexology group, reflexology hand massage applied between two suctioning period
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Reflexology massage methods applied randomly to both trial groups.
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Placebo Comparator: classical massage
In the classical massage group, classical hand massage applied between two suctioning period
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Classical hand massage methods applied randomly to both trial groups.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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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
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just before ETS and immediately after and 5th minute after ETS
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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just before ETS and immediately after and 5th minute after ETS
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heart rate of patients both reflexology and classical hand massage group
Time Frame: just before ETS and immediately after and 5th minute after ETS
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heart rate (heart rate/minute) was measured just before ETS and immediately after and 5th minute after ETS before and after massages
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just before ETS and immediately after and 5th minute after ETS
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respiratory frequency of patients both reflexology and classical hand massage group
Time Frame: just before ETS and immediately after and 5th minute after ETS
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respiratory frequency (respiratory frequency/minute) measured just before ETS and immediately after and 5th minute after ETS before and after massages
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just before ETS and immediately after and 5th minute after ETS
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tidal volume of patients both reflexology and classical hand massage group
Time Frame: just before ETS and immediately after and 5th minute after ETS
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tidal volume (ml) was measured just before ETS and immediately after and 5th minute after ETS before and after massages
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just before ETS and immediately after and 5th minute after ETS
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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
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peripheral oxygen saturation (%) measured just before ETS and immediately after and 5th minute after ETS before and after massages
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just before ETS and immediately after and 5th minute after ETS
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: İlkin Yılmaz, PhD, Assist Prof
- Principal Investigator: Gizem Göktuna, PhDc, Res Assis
- Principal Investigator: Gülşah Gürol Arslan, PhD, Assoc Prof
- Principal Investigator: Dilek Özden, PhD, Professor
Publications and helpful links
Helpful 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.
- Rejeh, N., Tadrisi, S. D., Yazdani, S., Saatchi, K., & Vaismoradi, M. (2020). The effect of hand reflexology massage on pain and fatigue in patients after coronary angiography: A randomized controlled clinical trial. Nursing Research and Practice, 2020.
- 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.
- McCullough, J. E. M., Liddle, S. D., Sinclair, M., Close, C., & Hughes, C. M. (2014). The physiological and biochemical outcomes associated with a reflexology treatment: A systematic review. Evidence-Based Complementary and Alternative Medicine, 2014.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 7074-GOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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