Clinical trial NCT05329519: The Effects of Listening Music During Breathing Exercises
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Complication
Nursing Caries
Pain, Postoperative
Keywords: Nursing
Thoracic surgery
Listening music
Deep breathing and coughing exercise
Pulmonary function
Vital signs
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
Collaborators: name: Eastern Mediterranean University
First posted: 2022-04-15
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: 2 parallel group randomized controlled
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: systolic blood pressure
timeFrame: through study completion, an average of 6 months
measure: diastolic blood pressure
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: forced vital capacity (FVC)
timeFrame: through study completion, an average of 6 months
measure: forced expiratory volume in one second (FEV1)
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Özgü Bakçek
state: Eyalet/Yerleşke
Study officials:
affiliation: Eastern Mediterrean University
name: Sevinc Tastan, Proffessor
role: STUDY_DIRECTOR
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