Endotracheal AspirationNCT05750524
The Effect of Hand Massage on Endotracheal Suctioning Pain and Hemodynamic Parameters
A study testing reflexology hand massage and classical hand massage in people with Endotracheal Aspiration and Pain, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Aspiration, Pain, Reflexology
- What is being tested?
- reflexology hand massage and classical hand massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jun 2022to 28 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hand Massage Applied With Two Different Methods 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.
Read the 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.
- Conditions
- Endotracheal Aspiration, Pain, Reflexology, Massage, Hemodynamic Instability
- Being tested
- reflexology hand massage, classical hand massage
- Keywords
- endotracheal suctioning, endotracheal aspiration, pain, hand massage, reflexology, hemodynamic parameters
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reflexology hand massageOther
Reflexology massage methods applied randomly to both trial groups.
classical hand massageOther
Classical hand massage methods applied randomly to both trial groups.
| Study group | Role | What they receive |
|---|---|---|
| reflexology | Experimental | In the reflexology group, reflexology hand massage applied between two suctioning period Receives: Other: reflexology hand massage |
| classical massage | Placebo comparator | In the classical massage group, classical hand massage applied between two suctioning period Receives: Other: classical hand massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: just before ETS and immediately after and 5th minute after ETS
Secondary outcomes (5)
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
Measured: just before ETS and immediately after and 5th minute after ETS
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
Measured: just before ETS and immediately after and 5th minute after ETS
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
Measured: just before ETS and immediately after and 5th minute after ETS
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
Measured: just before ETS and immediately after and 5th minute after ETS
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
Measured: just before ETS and immediately after and 5th minute after ETS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start21 Jun 2022
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal AspirationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilkin Yilmaz, Dokuz Eylul University
- Investigators
- İlkin Yılmaz, PhD, Study chair, Assist ProfGizem Göktuna, PhDc, Principal investigator, Res AssisGülşah Gürol Arslan, PhD, Principal investigator, Assoc ProfDilek Özden, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750524
- Sponsor's protocol ID
- 7074-GOA
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We cannot share participant data due to Turkish Personal Data Protection Law no. 6698
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Massage Applied With Two Different Methods on Endotracheal Suctioning Pain and Hemodynamic Parameters
- ClinicalTrials.gov ID
- NCT05750524
- Acronym / sponsor ID
- 7074-GOA
- Conditions
- Endotracheal Aspiration, Pain, Reflexology, Massage, Hemodynamic Instability
- Keywords
- endotracheal suctioning, endotracheal aspiration, pain, hand massage, reflexology, hemodynamic parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| reflexology | Experimental | Other: reflexology hand massageIn the reflexology group, reflexology hand massage applied between two suctioning period |
| classical massage | Placebo comparator | Other: classical hand massageIn the classical massage group, classical hand massage applied between two suctioning period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reflexology hand massageReflexology massage methods applied randomly to both trial groups. | Other | reflexology |
| classical hand massageClassical hand massage methods applied randomly to both trial groups. | Other | classical massage |
Primary outcome
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
5 secondary outcomes
blood pressures of patients both reflexology and classical hand massage group
Time frame: just before ETS and immediately after and 5th minute after ETS
heart rate of patients both reflexology and classical hand massage group
Time frame: just before ETS and immediately after and 5th minute after ETS
respiratory frequency of patients both reflexology and classical hand massage group
Time frame: just before ETS and immediately after and 5th minute after ETS
tidal volume 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 of patients both reflexology and classical hand massage group
Time frame: just before ETS and immediately after and 5th minute after ETS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Wang, H. L., \& Keck, J. F. (2004). Foot and hand massage as an intervention for postoperative pain. Pain Management Nursing, 5(2), 59-65.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. We cannot share participant data due to Turkish Personal Data Protection Law no. 6698
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlkin Yılmaz, PhD study chair
Assist Prof
Gizem Göktuna, PhDc principal investigator
Res Assis
Gülşah Gürol Arslan, PhD principal investigator
Assoc Prof
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reflexology hand massage and classical hand massage in people with Endotracheal Aspiration and Pain, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.