NCT05329519

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2017

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

March 22, 2022

Last Update Submit

April 7, 2022

Conditions

Keywords

NursingThoracic surgeryListening musicDeep breathing and coughing exercisePulmonary functionVital signs

Outcome Measures

Primary Outcomes (2)

  • systolic blood pressure

    mm Hg (millimeters of mercury)

    through study completion, an average of 6 months

  • diastolic blood pressure

    mm Hg (millimeters of mercury)

    through study completion, an average of 6 months

Secondary Outcomes (2)

  • forced vital capacity (FVC)

    through study completion, an average of 6 months

  • forced expiratory volume in one second (FEV1)

    through study completion, an average of 6 months

Study Arms (2)

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.

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

Interventions

Listening musicBEHAVIORAL

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.

Also known as: Music group
Music group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ă–zgĂ¼ Bakçek

Ankara, Eyalet/YerleÅŸke, 06010, Turkey (TĂ¼rkiye)

Location

Related Publications (33)

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    PMID: 34229858BACKGROUND
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    PMID: 30542000BACKGROUND
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    PMID: 26436600BACKGROUND
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    PMID: 16304303BACKGROUND
  • 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.

    PMID: 29892929BACKGROUND
  • Chou 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.

    PMID: 26827847BACKGROUND
  • 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.

    PMID: 32649395BACKGROUND
  • 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.

    PMID: 32901972BACKGROUND
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    PMID: 29629199BACKGROUND
  • 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.

    PMID: 26339666BACKGROUND
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    PMID: 26365452BACKGROUND
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    PMID: 22403963BACKGROUND
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MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sevinc Tastan, Proffessor

    Eastern Mediterrean University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 2 parallel group randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, RN, MSc

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 15, 2022

Study Start

June 15, 2016

Primary Completion

January 15, 2017

Study Completion

November 7, 2017

Last Updated

April 15, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations