- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05329519
The Effects of Listening Music During Breathing Exercises
The Effects of Listening Music During Breathing Exercises on Vital Sings and Pulmonary Functions After Video-assisted Thoracoscopic Surgery:A Randomized-controlled Study
Background and purpose : This study aims to analyze the effects of listening to music during deep breathing and coughing exercises on vital sings and pulmonary functions in patients, who underwent video assisted thoracoscopic surgery with wedge resection.
Materials and methods: This randomized and single-blinded study was conducted on 30 patients, including 15 patients in the music and the control groups. The patients were randomized into the music group, which listened to music during deep breathing and coughing exercises and the control group that only performed the exercises. Data were collected preoperatively and postoperatively. Patient information form, observation form and the visual analog scale were used for data collection.
Study Overview
Status
Intervention / Treatment
Detailed Description
2. Methods 2.1. Study design and setting This randomized trial was conducted at a research and training hospital in Ankara province of Turkey between June 2016 and January 2017.
2.2. Sample size Sample size was calculated with reference to the change in pain scores in a study of (music group: 29.7 ± 19.8, control group: 50.7±19.2). A total of 22 patients with 11 in each group were needed for Type I error of 0.05 and Type II error of 0.20. Given the possibility of withdrawals, study was intended to reach 30 patients with 15 in each group.
Since the patients in the control and intervention (music) groups could share their experiences before the surgery, randomized the patients weekly. With this aim, 'R Studio' software was used for block randomization to determine the groups that would receive the intervention on each week. The patients were single-blinded so that they were unaware of which group they had been assigned to.
Study included the voluntary patients age of 18 years and above the age of 18 years, who would undergo a video assisted thoracoscopic surgery with wedge resection, could read and write in Turkish, had no visual and auditory problems, and were categorized as ASA I, ASA II or ASA III patients according to the American Society of Anesthesiologists (ASA) physical status classification system. Patients with visual and auditory problems, who could not read or write in Turkish and priorly underwent a video assisted thoracoscopic surgery with wedge resection were excluded.
2.3. Tools Patient information form, observation from and the visual analog scale were used for data collection, which took place before the surgery and days 1, 2 and 3 postoperatively.
2.3.1. Patient Information Form The patient form was prepared by the researchers in line with the literature included four questions on the sociodemographic characteristics, such as age, gender, education level and working status, and two questions on the clinical characteristics, including, smoking and previous surgeries.
2.3.2. Observation Form The observation form was prepared by the researchers based on the literature and was used to record vital signs, such as. systolic and diastolic blood pressure (BP), heart rate, and the parameters of pulmonary functions, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and the ratio of FEV1 to FVC (FEV1/FVC).
2.3.3. Visual Analog Scale (VAS) The VAS, which is frequently used in clinical practice to evaluate pain, was first developed in 1992. VAS is usually a 10 cm (100mm) long horizontal or vertical line and the responses range from 'no pain' to 'worst pain'. It may be a straight line or may be divided into equal intervals. Patients put a cross on at the point that most accurately expresses their degree of pain. The validity and reliability of the Turkish version was confirmed in 2004.
2.4. Interventions Data were collected before and after the surgery. During the face-to-face interviews before the surgery, patients were informed about the aim of the study, gathered information on their sociodemographic and clinical characteristics, recorded vital signs and parameters about pulmonary functions and asked the patients to complete the VAS. Next, Patients were explained the importance of deep breathing and coughing exercises and demonstrated how to perform these exercises. Finally, delivered a booklet on the exercises, which was prepared by the researchers based on the literature.
Patients in both groups underwent video assisted thoracoscopic surgery with wedge recession and the same surgical methods were employed. After the surgery, the patients in the music group performed deep breathing and coughing exercises while listening to music for thirty minutes a day with a MPEG player 3 (Goldsmart Mp3-159 Player) and head phones on postoperative days 1, 2, and 3. A list of popular songs of different genres, including Turkish classical, folk, pop and rock music, classical music and foreign music, prepared and allowed them to choose the song to be listened. The patients in the controlled group, on the other hand, performed deep breathing and coughing exercises for three days without music. Vital signs and the parameters of pulmonary functions were recorded after each exercise.
The impact of music during deep berating and coughing exercises on vital signs and the parameters of pulmonary functions were recorded on postoperative days 1, 2 and 3. Datex Ohmeda (GE Healthcare, Finland) was used to measure vital signs, including heart rate, oxygen saturation and systolic and diastolic BP. Parameters of pulmonary functions were measured using One-Flow FVC Kit (3141001USB), and spirometer (Clement Clark Int.). A VAS was used to evaluate the intensity of pain.
2.5. Statistical analysis Statistical Package of Social Sciences (SPSS, Inc., Chicago, USA) version 15.0 was used for the analysis of collected data. As descriptive statistics, number (n) and frequency (%) were used for categorical variables while mean median and standard deviation were calculated for continuous variables. Shapiro-Wilk test was used to test the normality of the data. For intergroup comparison, we used the independent sample t-test if the data met normal distribution and the Mann-Whitney U-Test if the data did not meet normal distribution. The chi-square and Fisher's exact test were used to test for differences between categorical variables. Statistical significance was set at p < 0.05.
2.6. Ethical Considerations Before conducting this study, received permission from the ethical committee of the university (No. 50687469-1491-15-16/1648.4-115). The trial was conducted in accordance with the principles of Helsinki Declaration and verbal and written informed consent from all patients was obtained.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Eyalet/Yerleşke
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Ankara, Eyalet/Yerleşke, Turkey, 06010
- Özgü Bakçek
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Voluntary patients
- Age of 18 years and above the age of 18 years, who would undergo a video assisted thoracoscopic surgery with wedge resection,
- Patient could read and write in Turkish,
- Patient had no visual and auditory problems,
- Patient were categorized as ASA I, ASA II or ASA III patients according to the American Society of Anesthesiologists (ASA) physical status classification system.
Exclusion Criteria:
- Non-voluntary patients
- Under the age of 18 years
- Patients with visual and auditory problems, who could not read or write in Turkish
- Patients priorly underwent a VATS with wedge resection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Music group
Patients in this groups underwent VATS with wedge recession, performed deep breathing and coughing exercises while listening to music for thirty minutes a day with a MP3 player and head phones on postoperative three days.
|
Patients in both groups underwent VATS with wedge recession and the same surgical methods were employed.
After the surgery, the patients in the music group performed deep breathing and coughing exercises while listening to music for thirty minutes a day with a MP3 player (Goldmaster Goldsmart Mp3-159 Player) and head phones on postoperative days 1, 2, and 3. We prepared a list of popular songs of different genres, including Turkish classical, folk, pop and rock music, classical music and foreign music, and allowed them to choose the song to be listened.
Other Names:
|
NO_INTERVENTION: Controlled group
Patients in this groups underwent VATS with wedge recession, performed deep breathing and coughing exercises for postoperative three days without music
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
systolic blood pressure
Time Frame: through study completion, an average of 6 months
|
mm Hg (millimeters of mercury)
|
through study completion, an average of 6 months
|
diastolic blood pressure
Time Frame: through study completion, an average of 6 months
|
mm Hg (millimeters of mercury)
|
through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
forced vital capacity (FVC)
Time Frame: through study completion, an average of 6 months
|
Liter/Second
|
through study completion, an average of 6 months
|
forced expiratory volume in one second (FEV1)
Time Frame: through study completion, an average of 6 months
|
Liter/Second
|
through study completion, an average of 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Sevinc Tastan, Proffessor, Eastern Mediterrean University
Publications and helpful links
General Publications
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- Celebi D, Yilmaz E, Sahin ST, Baydur H. The effect of music therapy during colonoscopy on pain, anxiety and patient comfort: A randomized controlled trial. Complement Ther Clin Pract. 2020 Feb;38:101084. doi: 10.1016/j.ctcp.2019.101084. Epub 2019 Dec 23.
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- Agostini PJ, Lugg ST, Adams K, Smith T, Kalkat MS, Rajesh PB, Steyn RS, Naidu B, Rushton A, Bishay E. Risk factors and short-term outcomes of postoperative pulmonary complications after VATS lobectomy. J Cardiothorac Surg. 2018 Apr 12;13(1):28. doi: 10.1186/s13019-018-0717-6.
- Federici S, Gonzalez M. Uniportal video-assisted thoracoscopic right upper sleeve lobectomy. Multimed Man Cardiothorac Surg. 2019 Nov 26;2019. doi: 10.1510/mmcts.2019.043.
- Gupta S, Groen RS, Kyamanywa P, Ameh EA, Labib M, Clarke DL, Donkor P, Derbew M, Sani R, Kamara TB, Shrestha S, Nwomeh BC, Wren SM, Price RR, Kushner AL. Surgical care needs of low-resource populations: an estimate of the prevalence of surgically treatable conditions and avoidable deaths in 48 countries. Lancet. 2015 Apr 27;385 Suppl 2:S1. doi: 10.1016/S0140-6736(15)60796-6. Epub 2015 Apr 26.
- Lugg ST, Agostini PJ, Tikka T, Kerr A, Adams K, Bishay E, Kalkat MS, Steyn RS, Rajesh PB, Thickett DR, Naidu B. Long-term impact of developing a postoperative pulmonary complication after lung surgery. Thorax. 2016 Feb;71(2):171-6. doi: 10.1136/thoraxjnl-2015-207697.
- Hall DE, Arya S, Schmid KK, Carlson MA, Lavedan P, Bailey TL, Purviance G, Bockman T, Lynch TG, Johanning JM. Association of a Frailty Screening Initiative With Postoperative Survival at 30, 180, and 365 Days. JAMA Surg. 2017 Mar 1;152(3):233-240. doi: 10.1001/jamasurg.2016.4219.
- Bibo L, Goldblatt J, Merry C. Does preoperative pulmonary rehabilitation/physiotherapy improve patient outcomes following lung resection? Interact Cardiovasc Thorac Surg. 2021 May 27;32(6):933-937. doi: 10.1093/icvts/ivab011.
- Bevilacqua Filho CT, Schmidt AP, Felix EA, Bianchi F, Guerra FM, Andrade CF. Risk factors for postoperative pulmonary complications and prolonged hospital stay in pulmonary resection patients: a retrospective study. Braz J Anesthesiol. 2021 Jul-Aug;71(4):333-338. doi: 10.1016/j.bjane.2021.02.003. Epub 2021 Feb 3.
- Kutluk AC, Akin H, Ceritoglu A, Kocaturk CI, Bilen S, Sonmezoglu Y, Karapinar K. Is the Outcome of Pulmonary Resections due to Non-Small Cell Lung Cancer in Octogenarian Patients Worse? Ann Thorac Cardiovasc Surg. 2019 Apr 20;25(2):95-101. doi: 10.5761/atcs.oa.18-00206. Epub 2018 Dec 11.
- Westerdahl E, Lindmark B, Eriksson T, Friberg O, Hedenstierna G, Tenling A. Deep-breathing exercises reduce atelectasis and improve pulmonary function after coronary artery bypass surgery. Chest. 2005 Nov;128(5):3482-8. doi: 10.1378/chest.128.5.3482.
- Hanada M, Kanetaka K, Hidaka S, Taniguchi K, Oikawa M, Sato S, Eguchi S, Kozu R. Effect of early mobilization on postoperative pulmonary complications in patients undergoing video-assisted thoracoscopic surgery on the esophagus. Esophagus. 2018 Apr;15(2):69-74. doi: 10.1007/s10388-017-0600-x. Epub 2017 Dec 16.
- Chan SY, Chen CF. Effects of an Active Music Therapy Program on Functional Fitness in Community Older Adults. J Nurs Res. 2020 Oct;28(5):e111. doi: 10.1097/JNR.0000000000000391.
- Spagnuolo R, Corea A, Blumetti M, Giovinazzo A, Serafino M, Pagliuso C, Pagnotta R, Curto G, Cosco C, Cosco V, Mancina RM, Garieri P, Papaleo A, Grande L, Barilaro A, Garofalo E, Bruni A, Doldo P. Effects of listening to music in digestive endoscopy: A prospective intervention study led by nursing. J Adv Nurs. 2020 Nov;76(11):2993-3002. doi: 10.1111/jan.14516. Epub 2020 Sep 9.
- Ardo NP, Loizzi D, Panariti S, Piccinin I, Sollitto F. Enhanced recovery pathways in thoracic surgery from Italian VATS group: nursing care program. J Thorac Dis. 2018 Mar;10(Suppl 4):S529-S534. doi: 10.21037/jtd.2017.12.85.
- Forooghy M, Mottahedian Tabrizi E, Hajizadeh E, Pishgoo B. Effect of Music Therapy on Patients' Anxiety and Hemodynamic Parameters During Coronary Angioplasty: A Randomized Controlled Trial. Nurs Midwifery Stud. 2015 Jun;4(2):e25800. doi: 10.17795/nmsjournal25800. Epub 2015 Jun 27.
- Liu Y, Petrini MA. Effects of music therapy on pain, anxiety, and vital signs in patients after thoracic surgery. Complement Ther Med. 2015 Oct;23(5):714-8. doi: 10.1016/j.ctim.2015.08.002. Epub 2015 Aug 4.
- Binns-Turner PG, Wilson LL, Pryor ER, Boyd GL, Prickett CA. Perioperative music and its effects on anxiety, hemodynamics, and pain in women undergoing mastectomy. AANA J. 2011 Aug;79(4 Suppl):S21-7.
- Calik-Kutukcu E, Saglam M, Vardar-Yagli N, Cakmak A, Inal-Ince D, Bozdemir-Ozel C, Sonbahar-Ulu H, Arikan H, Yalcin E, Karakaya J. Listening to motivational music while walking elicits more positive affective response in patients with cystic fibrosis. Complement Ther Clin Pract. 2016 May;23:52-8. doi: 10.1016/j.ctcp.2016.03.002. Epub 2016 Mar 16.
- Zengin S, Kabul S, Al B, Sarcan E, Dogan M, Yildirim C. Effects of music therapy on pain and anxiety in patients undergoing port catheter placement procedure. Complement Ther Med. 2013 Dec;21(6):689-96. doi: 10.1016/j.ctim.2013.08.017. Epub 2013 Sep 1.
- Twiss E, Seaver J, McCaffrey R. The effect of music listening on older adults undergoing cardiovascular surgery. Nurs Crit Care. 2006 Sep-Oct;11(5):224-31. doi: 10.1111/j.1478-5153.2006.00174.x.
- Ozer N, Karaman Ozlu Z, Arslan S, Gunes N. Effect of music on postoperative pain and physiologic parameters of patients after open heart surgery. Pain Manag Nurs. 2013 Mar;14(1):20-8. doi: 10.1016/j.pmn.2010.05.002. Epub 2010 Dec 22.
- Schneider MA. The Effect of Listening to Music on Postoperative Pain in Adult Orthopedic Patients. J Holist Nurs. 2018 Mar;36(1):23-32. doi: 10.1177/0898010116677383. Epub 2016 Nov 10.
- Wang Y, Dong Y, Li Y. Perioperative psychological and music interventions in elderly patients undergoing spinal anesthesia: effect on anxiety, heart rate variability, and postoperative pain. Yonsei Med J. 2014 Jul;55(4):1101-5. doi: 10.3349/ymj.2014.55.4.1101.
- Ugras GA, Yildirim G, Yuksel S, Ozturkcu Y, Kuzdere M, Oztekin SD. The effect of different types of music on patients' preoperative anxiety: A randomized controlled trial. Complement Ther Clin Pract. 2018 May;31:158-163. doi: 10.1016/j.ctcp.2018.02.012. Epub 2018 Feb 17.
- Zhang ZS, Wang XL, Xu CL, Zhang C, Cao Z, Xu WD, Wei RC, Sun YH. Music reduces panic: an initial study of listening to preferred music improves male patient discomfort and anxiety during flexible cystoscopy. J Endourol. 2014 Jun;28(6):739-44. doi: 10.1089/end.2013.0705. Epub 2014 Mar 31.
- Ulubay G, Dilektasli AG, Borekci S, Yildiz O, Kiyan E, Gemicioglu B, Saryal S. Turkish Thoracic Society Consensus Report: Interpretation of Spirometry. Turk Thorac J. 2019 Jan 1;20(1):69-89. doi: 10.5152/TurkThoracJ.2018.180175.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YuksekIhtisas
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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