The Effect of Music Therapy in COVID-19 Patients Given Prone Position

NCT05038514 | Completed DMC

• 1 other identifier: 2100014997
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Almost half of the patients diagnosed with COVID-19 pneumonia develop ARDS and most of these patients are treated in the intensive care unit. In the management of COVID-19 ARDS, prone position is applied to improve physiological parameters by facilitating better distribution of tidal volume and drainage of secretions. It has been reported that awake patients in COVID clinics could not adapt their prone position due to anxiety . Jiang et al (2020) reported that awake patients may not tolerate the prone position and may experience anxiety due to posture habits and discomfort. It was determined that anxiety developed on the second day of hospitalization in the intensive care unit, state anxiety was associated with trait anxiety and pain, and anxiety was low in patients receiving mental health care/treatment . And also not to change position himself of patient in prone position due to care equipment etc it can cause loss of self-control and anxiety. Twelve-sixteen hour prone position recommendation for clinical improvement, positioning difficulties in patients who cannot position themselves may also trigger anxiety in awake patients It has been suggested that music therapy may be effective in reducing anxiety related to weaning from mechanical ventilation in COVID-19 patients. Music therapy intervention in ICU has been tested in sessions of at least 30 minutes, 1-30 days, with options such as western music, classical Chinese music, nature-based music. In the study of Chu and Zhang (2021), it was shown that the recovery time for tomography findings, the number of days of hospital stay and the rates of transfer to the intensive care unit were lower in the patient group who received holistic mode including traditional Chinese medicine, music therapy, and emotional support in COVID-19 patients. Studies evaluating the effectiveness of music therapy alone in the COVID-19 intensive care process could not be reached. It is thought that music therapy applied in the prone position in the COVID-19 intensive care unit will reduce the anxiety of the patients, adapt to the prone position and improve their clinical parameters.

Conditions

Music Therapy; Anxiety; Respiratory Distress Syndrome; Intensive Care Units; Nursing

Keywords

COVID-19; Prone position

Outcome Measures

Primary Outcomes (6)

• anxiety

  State Anxiety Inventory

  change from baseline state anxiety after position change at one day

• vital signs

  pulse rate

  change from baseline pulse rate after position change at one day

• vital signs

  respiratory rate

  change from baseline respiratory rate after position change at one day

• vital signs

  blood pressure

  change from baseline blood pressure after position change at one day

• vital signs

  oxygen saturation

  change from baseline oxygen saturation after position change at one day

• prone position adaptation

  length of stay in prone position

  time/hour to stay in prone position at one day

Study Arms (2)

music therapy

EXPERIMENTAL

Music therapy intervention, bluetooth headphones will be applied in the intensive care unit and will be disinfected after the application. The intervention consists of a 30-minute, single-session, nature-based music concert. the music concert is calibrated by the audiologist (60 decibels). During nature-based music listening, patients will be asked to close their eyes, rest and follow the sound flow.

Other: musıc therapy

control

NO INTERVENTION

The control group will be given the prone position and music therapy will not be applied.

Interventions

musıc therapy OTHER

After the prone position was given to the patients, according to the randomization table, the intervention group was given 30 minutes by the nurse. nature-based music therapy will be applied.

music therapy

Eligibility Criteria

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

You may qualify if:

• Adult patients between the ages of 18-80
• Developing respiratory failure due to COVID-19
• Prone position applied
• Staying in intensive care unit for at least 24 hours
• Awake and cooperative
• Recipient of oxygen mask or high-flow oxygen therapy or noninvasive mechanical ventilation support
• Stable hemodynamic status

You may not qualify if:

• Those who do not agree to participate in the research
• Those with communication barrier problems
• Intubated
• Sedation drug applied
• Those who need emergency intervention during work
• Having a diagnosis of neurological and psychological medicine
• Abnormal deterioration in physiological parameters
• Patients transferred to another service or discharged
• patients with hearing impairment

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Antalya Kepez State Hospital Intensive Care Unit

Antalya, 07320, Turkey (Türkiye)

Location

Related Publications (13)

• Bamford, P., Bentley, A., Dean, J., Whitmore, D. & Wilson-Baig, N. ICS guidance for prone positioning of the conscious COVİD-19 patient 2020. London: Intensive Care Society, 2020. (01.10.2020 tarihinde https://emcrit.org/wp-content/uploads/2020/04/2020-04-12-Guidance-for-conscious-proning.pdf adresinden ulaşılmıştır).

  BACKGROUND

• Bastoni D, Poggiali E, Vercelli A, Demichele E, Tinelli V, Iannicelli T, Magnacavallo A. Prone positioning in patients treated with non-invasive ventilation for COVID-19 pneumonia in an Italian emergency department. Emerg Med J. 2020 Sep;37(9):565-566. doi: 10.1136/emermed-2020-209744. Epub 2020 Jul 6.

  PMID: 32748797 BACKGROUND

• Chu L, Zhang Y. A study on nursing effect of integrated traditional Chinese and Western medicine management mode on COVID-19. Jpn J Nurs Sci. 2021 Mar 7;18(3):e12411. doi: 10.1111/jjns.12411. Online ahead of print.

  PMID: 33682284 BACKGROUND

• Dwitasari, M. A. D., & Laksmidewi, A. A. A. P. (2020). Convalescent Plasma Therapy in Effort of Weaning from Mechanical Ventilation Using Music Stimulation in Severe COVİD-19 Patients. Open Access Macedonian Journal of Medical Sciences, 8(T1), 192-197.

  BACKGROUND

• Elkattawy S, Noori M. A case of improved oxygenation in SARS-CoV-2 positive patient on nasal cannula undergoing prone positioning. Respir Med Case Rep. 2020 May 4;30:101070. doi: 10.1016/j.rmcr.2020.101070. eCollection 2020.

  PMID: 32368483 BACKGROUND

• Gibson PG, Qin L, Puah SH. COVID-19 acute respiratory distress syndrome (ARDS): clinical features and differences from typical pre-COVID-19 ARDS. Med J Aust. 2020 Jul;213(2):54-56.e1. doi: 10.5694/mja2.50674. Epub 2020 Jun 22. No abstract available.

  PMID: 32572965 BACKGROUND

• Golino AJ, Leone R, Gollenberg A, Christopher C, Stanger D, Davis TM, Meadows A, Zhang Z, Friesen MA. Impact of an Active Music Therapy Intervention on Intensive Care Patients. Am J Crit Care. 2019 Jan;28(1):48-55. doi: 10.4037/ajcc2019792.

  PMID: 30600227 BACKGROUND

• Hunter BC, Oliva R, Sahler OJ, Gaisser D, Salipante DM, Arezina CH. Music therapy as an adjunctive treatment in the management of stress for patients being weaned from mechanical ventilation. J Music Ther. 2010 Fall;47(3):198-219. doi: 10.1093/jmt/47.3.198.

  PMID: 21275332 BACKGROUND

• Latuapo, A., Farid, M., & Ab Rahman, Z. (2020). Pharmaceutıcal and Nonpharmaceutıcal Use Of Musıc and Al-Quran Therapy in Preventıng The Spread Of Pandemıcs (Covıd-19): A Systematıc Revıew. Systematic Reviews in Pharmacy, 11(12), 1171-1179.

  BACKGROUND

• Shang Y, Pan C, Yang X, Zhong M, Shang X, Wu Z, Yu Z, Zhang W, Zhong Q, Zheng X, Sang L, Jiang L, Zhang J, Xiong W, Liu J, Chen D. Management of critically ill patients with COVID-19 in ICU: statement from front-line intensive care experts in Wuhan, China. Ann Intensive Care. 2020 Jun 6;10(1):73. doi: 10.1186/s13613-020-00689-1.

  PMID: 32506258 BACKGROUND

• Somagutta, M. R., Pormento, M. K. L., Khan, M. A., Hamdan, A., & Dodla, S. N. (2021). 262: Awake Self Prone Positioning Outcomes in Nonintubated COVİD-19 Patients. Critical Care Medicine, 49(1), 118.

  BACKGROUND

• Wormser J, Romanet C, Philippart F. Prone position in wards for spontaneous breathing Covid-19 patients: a retrospective study. Ir J Med Sci. 2021 Nov;190(4):1519-1522. doi: 10.1007/s11845-020-02479-x. Epub 2021 Jan 15.

  PMID: 33449332 BACKGROUND

• Froutan R, Eghbali M, Hoseini SH, Mazloom SR, Yekaninejad MS, Boostani R. The effect of music therapy on physiological parameters of patients with traumatic brain injury: A triple-blind randomized controlled clinical trial. Complement Ther Clin Pract. 2020 Aug;40:101216. doi: 10.1016/j.ctcp.2020.101216. Epub 2020 Jun 30.

  PMID: 32891292 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Halil İbrahim KARAÇAR, RN

  Antalya Kepez State Hospital Intensive Care Unit

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blind (i.e., triple-masking) studies are randomized experiments in which the treatment or intervention is unknown to (a) the research participant, (b) the individual(s) who administer the treatment or intervention, and (c) the individual(s) who assess the outcomes
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: A triple-blind randomized controlled clinical trial

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 9, 2021
• Study Start: September 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)