Perioperative ComplicationNCT05329519
The Effects of Listening Music During Breathing Exercises
A study testing Listening music in people with Perioperative Complication and Nursing Caries, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Perioperative Complication, Nursing Caries, Pain, Postoperative
- What is being tested?
- Listening music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2016to 7 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
- 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.
- Being tested
- Listening music
- Keywords
- Nursing, Thoracic surgery, Listening music, Deep breathing and coughing exercise, Pulmonary function, Vital signs
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening musicBehavioural
Also called Music group
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.
| Study group | Role | What they receive |
|---|---|---|
| Music group | Experimental | 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. Receives: Behavioral: Listening music |
| Controlled group | No intervention | Patients in this groups underwent VATS with wedge recession, performed deep breathing and coughing exercises for postoperative three days without music |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure
mm Hg (millimeters of mercury)
Measured: through study completion, an average of 6 months
diastolic blood pressure
mm Hg (millimeters of mercury)
Measured: through study completion, an average of 6 months
Secondary outcomes (2)
forced vital capacity (FVC)
Liter/Second
Measured: through study completion, an average of 6 months
forced expiratory volume in one second (FEV1)
Liter/Second
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start15 Jun 2016
- Primary completion15 Jan 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 parallel group randomized controlled
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Mediterranean University
- Responsible party
- Principal investigator, Ozgu Bakcek, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Sevinc Tastan, Proffessor, Study director, Eastern Mediterrean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329519
- Sponsor's protocol ID
- YuksekIhtisas
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Campos JH, Peacher D. Choosing the Best Method for Postoperative Regional Analgesia After Video-Assisted Thoracoscopic Surgery. J Cardiothorac Vasc Anesth. 2020 Jul;34(7):1877-1880. doi: 10.1053/j.jvca.2020.02.043. Epub 2020 Feb 29. No abstract available.
PubMed 32253088Agostini 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.
PubMed 29673386Federici 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.
PubMed 31990152Gupta 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.
PubMed 26313055Lee CHA, Kong JC, Ismail H, Riedel B, Heriot A. Systematic Review and Meta-analysis of Objective Assessment of Physical Fitness in Patients Undergoing Colorectal Cancer Surgery. Dis Colon Rectum. 2018 Mar;61(3):400-409. doi: 10.1097/DCR.0000000000001017.
PubMed 29377872Lugg 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.
PubMed 26769017Hall 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.
PubMed 27902826Bibo 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.
PubMed 33907813Bevilacqua 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.
PubMed 34229858Kutluk 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.
PubMed 30542000Katsura M, Kuriyama A, Takeshima T, Fukuhara S, Furukawa TA. Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD010356. doi: 10.1002/14651858.CD010356.pub2.
PubMed 26436600Westerdahl 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.
PubMed 16304303Hanada 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.
PubMed 29892929Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
PubMed 26827847Chan 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.
PubMed 32649395
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Listening Music During Breathing Exercises on Vital Sings and Pulmonary Functions After Video-assisted Thoracoscopic Surgery:A Randomized-controlled Study
- ClinicalTrials.gov ID
- NCT05329519
- Acronym / sponsor ID
- YuksekIhtisas
- Keywords
- Nursing, Thoracic surgery, Listening music, Deep breathing and coughing exercise, Pulmonary function, Vital signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Collaborators
- Eastern Mediterranean University
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 parallel group randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Behavioral: Listening musicPatients 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. |
| Controlled group | No intervention | –Patients in this groups underwent VATS with wedge recession, performed deep breathing and coughing exercises for postoperative three days without music |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Listening musicAlso: Music groupPatients 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. | Behavioural | Music group |
Primary outcome
systolic blood pressure
Time frame: through study completion, an average of 6 months
mm Hg (millimeters of mercury)
diastolic blood pressure
Time frame: through study completion, an average of 6 months
mm Hg (millimeters of mercury)
2 secondary outcomes
forced vital capacity (FVC)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Background: PubMed 32253088Campos JH, Peacher D. Choosing the Best Method for Postoperative Regional Analgesia After Video-Assisted Thoracoscopic Surgery. J Cardiothorac Vasc Anesth. 2020 Jul;34(7):1877-1880. doi: 10.1053/j.jvca.2020.02.043. Epub 2020 Feb 29. No abstract available.
- Background: PubMed 29673386Agostini 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.
- Background: PubMed 31990152Federici 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.
- Background: PubMed 26313055Gupta 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.
- Background: PubMed 29377872Lee CHA, Kong JC, Ismail H, Riedel B, Heriot A. Systematic Review and Meta-analysis of Objective Assessment of Physical Fitness in Patients Undergoing Colorectal Cancer Surgery. Dis Colon Rectum. 2018 Mar;61(3):400-409. doi: 10.1097/DCR.0000000000001017.
- Background: PubMed 26769017Lugg 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.
- Background: PubMed 27902826Hall 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.
- Background: PubMed 33907813Bibo 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.
- Background: PubMed 34229858Bevilacqua 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.
- Background: PubMed 30542000Kutluk 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.
- Background: PubMed 26436600Katsura M, Kuriyama A, Takeshima T, Fukuhara S, Furukawa TA. Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD010356. doi: 10.1002/14651858.CD010356.pub2.
- Background: PubMed 16304303Westerdahl 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.
- Individual participant dataSharing planned: No
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Pancreatic Cancer, Periampullary Cancer
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevinc Tastan, Proffessor study director
Eastern Mediterrean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening music in people with Perioperative Complication and Nursing Caries, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure (time frame: through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05329519, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.