The Effect of Hand Massage on Endotracheal Suctioning Pain and Hemodynamic Parameters

Sponsor
Dokuz Eylul University (Other)
Overall Status
Completed
CT.gov ID
NCT05750524
Collaborator
(none)
24
1
2
1.2
19.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: reflexology hand massage
  • Other: classical hand massage
N/A

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

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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 (Participant, Investigator)
Masking Description:
Patients and the investigator doing the suctioning and assessing the patient's pain and vital signs will be masked.
Primary Purpose:
Prevention
Official Title:
The Effect of Hand Massage Applied With Two Different Methods on Endotracheal Suctioning Pain and Hemodynamic Parameters
Actual Study Start Date :
Jun 21, 2022
Actual Primary Completion Date :
Jul 28, 2022
Actual Study Completion Date :
Jul 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: reflexology

In the reflexology group, reflexology hand massage applied between two suctioning period

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

Placebo Comparator: classical massage

In the classical massage group, classical hand massage applied between two suctioning period

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

Outcome Measures

Primary Outcome Measures

  1. change from baseline pain level of patients at 5 minutes both reflexology and classical hand massage group [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 Outcome Measures

  1. blood pressures of patients both reflexology and classical hand massage group [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ilkin Yilmaz İzmir Turkey 35340

Sponsors and Collaborators

  • Dokuz Eylul University

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Ilkin Yilmaz, Assist Prof., Ph.D., Dokuz Eylul University
ClinicalTrials.gov Identifier:
NCT05750524
Other Study ID Numbers:
  • 7074-GOA
First Posted:
Mar 1, 2023
Last Update Posted:
Mar 1, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ilkin Yilmaz, Assist Prof., Ph.D., Dokuz Eylul University

Study Results

No Results Posted as of Mar 1, 2023