The Effect of Passive Music Therapy and Foot Massage

NCT06078826 | Completed

• 1 other identifier: Pinar
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

Patients hospitalized in tertiary intensive care units are connected to mechanical ventilators due to multiorgan failure, chronic diseases, respiratory failure, etc. Endotracheal aspiration is then necessary to maintain respiratory patency. However, patients feel a lot of pain during this application. Pharmacological methods for pain relief are mostly used in intensive care units. These methods can have many complications. In this study, it was aimed to determine the effect of passive music therapy and foot massage, which are non-pharmacological methods, on hemodynamic status in relieving pain and anxiety that may develop due to this. Reducing the use of pharmacological methods and switching to non-pharmacological methods in pain relief will increase the quality of patient care and recovery results. This research will be conducted as a prospective, randomized controlled, single-blind, experimental. In the study, passive music therapy will be applied to one of the intervention groups and foot massage will be applied to the other in the tracheal aspiration process, and no application will be made to the control group. Passive music therapy and foot massage will be applied for 30 minutes during the tracheal aspiration procedure. Evaluation will be made before, during and after the application. When the literature is examined, there are few studies examining the effect of foot massage in intensive care patients, but no studies evaluating the effect of foot massage during the aspiration procedure have been found. For this reason, it is thought that passive music therapy and foot massage applied in the aspiration process in intensive care patients will reduce the level of pain and anxiety, thus positively affecting the hemodynamic status of the patient, increasing the comfort of the patient and improving the results of nursing care. Thus, it is planned to bring an original study that has not been done on the subject to the literature.

Conditions

Intensive Care Patients

Keywords

Music therapy; Foot massage; Pain; Anxiety; Intensive care

Outcome Measures

Primary Outcomes (6)

• Facial Anxiety Scale.

  Facial Anxiety Scale was developed by Mckinley et al. (2003) to determine anxiety levels in intensive care patients. The scale consists of five different face types in the form of a card measuring 11x42 cm. While the anxiety level increases towards the face type in the left corner of the card, the anxiety level decreases towards the right corner. Anxiety face scale score evaluation is expressed as three points as medium level, three points above as high level, that is, three points and above as medium to high level.

  30 minutes before tracheal aspiration; during tracheal aspiration;30 minutes after tracheal aspiration

• Temperature will be measured from vital signs

  Body temperature will be measured with a thermometer device.

  30 minutes before tracheal aspiration; during tracheal aspiration; 30 minutes after tracheal aspiration

• Measurement of the patient's pulse rate

  Pulse measurement will be measured with the help of a monitor.

  30 minutes before tracheal aspiration; during tracheal aspiration; 30 minutes after tracheal aspiration

• Determination of respiratory rate

  The patient's respiratory rate will be measured with the help of a monitor.

  30 minutes before tracheal aspiration; during tracheal aspiration; 30 minutes after tracheal aspiration

• Determination of the patient's blood pressure

  The patient's blood pressure will be measured with the help of a monitor.

  30 minutes before tracheal aspiration; during tracheal aspiration; 30 minutes after tracheal aspiration

• Behavioral Pain Scale

  Behavioral Pain Scale (DAS) consists of three subscales, including facial expression,

  30 minutes before tracheal aspiration; during tracheal aspiration; 30 minutes after tracheal aspiration

Study Arms (3)

passive music therapy group

EXPERIMENTAL

Intubated patients on mechanical ventilator hospitalized in the 3rd Stage Intensive Care Unit will be included in the intervention group 48 hours after admission. The data of the individuals will be collected by face-to-face interview method in the "Ramsey Sedation Scale", "Patient Identification Form", "Patient Follow-up Form", "Behavioral Pain Scale" to determine the level of pain, and "Facial Anxiety Scale" to determine the level of anxiety at the first interview. Before the tracheal aspiration procedure, passive music therapy will be applied for 30 minutes and throughout the aspiration, and during this application, music will be continued for approximately two more minutes (15 seconds of first aspiration, 30 seconds of break, 15 seconds of second aspiration) during both aspirations. Patient Follow-up Form, Behavioral Pain Scale and Face Anxiety Scale will be filled again during and after tracheal aspiration (30 minutes later).

Other: passive music therapy

foot massage group

EXPERIMENTAL

Intubated patients on mechanical ventilator hospitalized in the 3rd Stage Intensive Care Unit will be included in the intervention group 48 hours after admission. The data of the individuals will be collected by face-to-face interview method in the "Ramsey Sedation Scale", "Patient Identification Form", "Patient Follow-up Form", "Behavioral Pain Scale" to determine the level of pain, and "Facial Anxiety Scale" to determine the level of anxiety at the first interview. Foot massage will be applied for 30 minutes before the tracheal aspiration process and throughout the aspiration, and the music will be continued for approximately two more minutes (15 seconds of first aspiration, 30 seconds of break, 15 seconds of second aspiration) during both aspirations. Patient Follow-up Form, Behavioral Pain Scale and Face Anxiety Scale will be filled again during and after tracheal aspiration (30 minutes later).

Other: foot massage

control group

NO INTERVENTION

No intervention will be made to the control group, and the routine care practice of the clinic will be applied. "Ramsey Sedation Scale", "Patient Identification Form", "Patient Follow-up Form", "Behavioral Pain Scale" to determine pain level, "Behavioral Pain Scale" to determine the level of anxiety, at the first interview 48 hours after hospitalization in intubated patients hospitalized in the 3rd Stage Intensive Care Unit. Data will be collected by face-to-face interview method, "Face Anxiety Scale". Hemodynamic parameters will be recorded. Patient Follow-up Form, Behavioral Pain Scale and Face Anxiety Scale will be filled again during and after tracheal aspiration (30 minutes later).

Interventions

passive music therapy OTHER

30 minutes before tracheal aspiration to intubated patients connected to mechanical ventilator treated in the 3rd step intensive care unit. and music between 60-74 dB will be played via headphones and MP3 player during aspiration (Şahin, 2018). This music is a 30-minute Hüseyni makam mp3 music recording . Hüseyni makam is effective in the morning and at dawn, and its effect is high between morning and noon. For this reason, passive music therapy practice in the research will be done by the researcher in the morning and afternoon. This maqam has beauty, benevolence, silence, comfort, a sense of peace and a refreshing feature. It has positive effects on the liver, heart, internal organs and spirit and unites with nature.

passive music therapy group

foot massage OTHER

Massage will be applied by the researcher in the research. Towel, sponge, etc. under the foot to be worked on. The foot will be held at a 45 degree angle While applying, 1-2 drops of liquid Vaseline will be used to moisten the hand. A total of 30 minutes of foot massage will be made for each individual, 15 minutes per foot. Foot massage will start 30 minutes before the start of aspiration and massage will continue throughout the aspiration period. Since the speed of the massage movements and the number of repetitions should be at the normal frequency, the massage will be done at a speed that does not disturb the individual, has a non-stimulating and calming effect and does not tire the practitioner. In the massage, efflorescence (stroking), petrissage and friction (circular rubbing) movements that support circulation and relax the tissues will be used. Evaluations will be made before the foot massage, at the end of the foot massage and 30 minutes after the foot massage.

foot massage group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old and above, 80 years old and below,
• Treated in the 3rd level intensive care unit for at least 48 hours,
• Not diagnosed with a psychiatric disease,
• Hemodynamically stable,
• Needing endotracheal aspiration,
• Not exposed to a painful procedure for at least one hour before the endotracheal aspiration procedure,
• Patients who do not receive high-dose inotropic support (Dopamine and/or Dobutamine 10 mcg/kg/hour) Patients who do not receive medical treatment for chronic pain
• Intubated and therefore unable to speak or verbally report pain, Ramsey Sedation Patients with 2 and 3 levels of alertness according to the scale

You may not qualify if:

• Hearing problem,
• Having any limb, vascular problem or wound that prevents foot massage,
• Thrombophlebitis, occlusive artery disease, fever etc. It is inconvenient to apply massage due to illness,
• Endotracheal aspiration procedure (mouth/jaw/face etc. trauma, intracranial pressure being affected) is not applicable,
• Patients who did not agree to participate in the study

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (2)

Pinar Tekinsoy Kartin

Melikgazi, Kayseri, 38039, Turkey (Türkiye)

Location

Erciyes University

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Pınar Tekinsoy Kartın, Ph.D

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients who meet the research criteria will be numbered after they are determined by the researcher. It will be determined and recorded by the researcher in the digital randomization environment (https://www.randomizer.org/ internet address), which is a simple randomization method, where the enumerated patients will be assigned to the intervention or control group. After randomization, passive music therapy and foot massage will be applied to the patients in the intervention group, and no treatment will be given to the control group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: The research is planned as a prospective, randomized controlled, single-blind, experimental study. The research will be carried out in the 3rd Level Intensive Care Units of Ömer Halisdemir University Training and Research Hospital located in Niğde City Center. The population of this study will consist of patients receiving mechanical ventilator support, who are intubated in the 3rd Level Intensive Care Units of Ömer Halisdemir University Training and Research Hospital in the city center of Niğde. The sample of the study was 'The Effect of Foot Massage on Pain of the Intensive Care Patients:A Parallel Randomized Single-Blind Controlled' study by Momeni et al. (2020), based on pain, power :0.90, type II- error 10%, confidence When the range of 1.96 is taken as a reference, the experimental groups that should be taken as a minimum were calculated as 25 and the control group 25 as a total of 75 patients.

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: October 12, 2023
• Study Start: January 2, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-09

Locations

TU (2)