Clinical trial NCT05038514: The Effect of Music Therapy in COVID-19 Patients Given Prone Position
Official title: The Effect of Music Therapy on Adaptation and Anxiety Levels in COVID-19 Patients Given Prone Position: A Triple-blind Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music Therapy
Anxiety
Respiratory Distress Syndrome
Intensive Care Units
Nursing
Keywords: COVID-19
Prone position
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A triple-blind randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The Corona virus disease 2019 Pandemic (COVID-19) has caused a psychosocial depression in the world. Acute severe or critical condition has been observed in 20% of individuals diagnosed with COVID-19. It is stated that viral pneumonia or Acute Respiratory Distress Syndrome (ARDS) and organ failures develop in these individuals. 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 is thought that the prone position will be more effective in the early stages of the disease and awake patients. It is recommended that the prone position especially in moderate to severe ARDS cases be applied for at least 12 hours after symptoms stabilize. Elkattawy and Noori (2020) reported that at least 6-8 hours of prone position improves oxygenation in the COVID-19 case without ARDS criteria. Mac Sweeney et al. (2020) reported that clinical parameters improved, intubation and ventilator requirement were delayed in an awake, self-prone COVID-19 case. However, Somagutta et al (2021) reported anxiety, back pain, adjustment and tolerance problems in awake and not mechanically ventilated patients. Bastoni et al, in the study which they evaluated prone adapt at emergency department in Italy; it is reported positioning could not be maintained in four out of ten patients due to unconformity, pain, and rejection of prone position. 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.

Music therapy is applied as a non-pharmacological nursing intervention in the anxiety management of patients in intensive careIt is stated that music therapy is effective in stress-anxiety management, improves vital signs and sleep quality, and may have a muscle relaxant effect in interventions applied in covid-19. 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. It has been reported that music therapy applied with all types of music provides normal heart rate, respiratory recovery and muscle relaxation. Golino et al. listened to music for 30 minutes according to the preferences of the patients in the intensive care unit and their vital signs, pain and anxiety were evaluated. While there was an improvement in heart rate and respiration, oxygen saturations did not change. At the same time, patients reported less pain and anxiety. 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.

Objective: The aim of this study is to evaluate the effect of music therapy applied in the prone position on anxiety, compliance with the prone position, and vital signs in patients diagnosed with COVID-19 in the intensive care unit.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: anxiety
timeFrame: change from baseline state anxiety after position change at one day
measure: vital signs
timeFrame: change from baseline pulse rate after position change at one day
measure: vital signs
timeFrame: change from baseline respiratory rate after position change at one day
measure: vital signs
timeFrame: change from baseline blood pressure after position change at one day
measure: vital signs
timeFrame: change from baseline oxygen saturation after position change at one day
measure: prone position adaptation
timeFrame: time/hour to stay in prone position at one day
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Kepez State Hospital Intensive Care Unit
Study officials:
affiliation: Antalya Kepez State Hospital Intensive Care Unit
name: Halil İbrahim KARAÇAR, RN
role: STUDY_CHAIR
References:
citation: 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).
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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