Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202309620440045 Date of Approval: 12/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of music on patient anxiety undergoing bronchoscopy : A randomised controlled trial
Official scientific title The effect of music on patient anxiety undergoing bronchoscopy : A randomised controlled trial
Brief summary describing the background and objectives of the trial bronchoscopy is a major procedure in pulmonology. It is performed for diagnostic or therapeutic purposes. Major life-threatening complications are rare. Although it is considered to be a safe method with rare complications, bronchoscopy is often associated with anxiety, stress and discomfort in patients, which can lead to a more difficult or incomplete procedure. Appropriate patient education about the procedure and sufficient pre-medication and anesthesia are necessary but may not be sufficient to reduce patient anxiety . Indeed, this feeling of stress, fear and discomfort is multi-factorial and depends not only on the education and information provided to the patient, but also on the experience of the operator and the patient's history . However, acting on these different factors may be insufficient. Several pharmacological and non-pharmacological methods can therefore be implemented in order to win this care challenge. At present, sedation can be used during endoscopic procedures to reduce patient anxiety and discomfort, but the rate of cardiorespiratory complications is high and the cost is not insignificant. Several non-pharmacological methods have been suggested for this purpose, such as hypnosis, acupuncture and audio-visual distraction. Music therapy is a form of therapy that uses music as a therapeutic method. Its effect on anxiety and stress has been demonstrated in a variety of domains . Its effect on anxiety during endoscopic procedures has been tested, particularly during digestive endoscopy . Very few studies have investigated the effect of music during bronchoscopy, with contradictory results. The aim of our study is to evaluate the effect of music on patient anxiety levels during bronchoscopy .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial musictherapy
Anticipated trial start date 02/04/2023
Actual trial start date 02/04/2023
Anticipated date of last follow up 30/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 138
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group no musictherapy earphones without music 10min before, during and 10 min after bronchoscopy 10 min before the start of bronchoscopy , patients will be given 2 earphones related to an MP3 player , for this group no music wil be displayed. Patients were told not to disclose the allocation. The STAI , respiratory and hemodynamic constants before and after bronchoscopy wil be recorded 68 Placebo
Experimental Group musictherapy a 30 min playlist of tunisian music prepared by musictherapist 10min before, during and 10 min after bronchoscopy 10min before the bronchoscopy , patients will be given 2 earphones related to an MP3 player containing the playlist of music already prepared . To ensure blinding to the investigator and the bronchoscopist, a collaborator not participating in the study will adjust the earpugs and the volume so that the music does not interfere with patient communication , before the entrance of the inverstigator and the bronchoscopist .Patients were told not to disclose the allocation. The STAI , the VAS , respiratory and hemodynamic constants will be recorded before and after the bronchoscopy 68
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ability to communicate patients with indication for bronchoscopy participants who could understand and give consent hearing impairment memory impairment consciousness disorders excluded if the FB was interrupted for any reason Patients undergoing psychiatric treatment for anxiety disorders and/or taking anxiolytic or sedative medication ICU admission needed Ventilated patients Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/03/2023 The Ethics Committee of the Faculty of Medicine of Sousse
Ethics Committee Address
Street address City Postal code Country
med Karoui sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the effect of music on anxiety level using Speilberg STAI State, form Y , 10min before and after bronchoscopy 10 min before and after bronchoscopy
Secondary Outcome the effect of music on comfort level using VAS visual analogic scale 10 min before and after bronchoscopy
Secondary Outcome hemodynamic and respiratory constants such as blood pressure heart rate oxygene saturation before and after bronchoscopy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Farhat Hached University Hospital Ibn Jazzar sousse 4031 Tunisia
Ibnaljazzar University Hospital ibn Jazzar kairouan 3100 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded ibn jazzar sousse 4031 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amani Kacem sahloul sousse 4054 Tunisia Individual
Primary Sponsor Sana Aissa sahloul sousse 4054 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amani Kacem kacem.amani@gmail.com +21694489837 ibnjazzar
City Postal code Country Position/Affiliation
sousse 4031 Tunisia IbnJazzar university hospital
Role Name Email Phone Street address
Public Enquiries Sana Aissa dr.aissa.sana@gmail.com 0021655803301 ibn jazzar
City Postal code Country Position/Affiliation
sousse 4031 Tunisia Farhat Hached University Hospital
Role Name Email Phone Street address
Scientific Enquiries Sana Aissa dr.aissa.sana@gmail.com 0021655803301 ibn jazzar
City Postal code Country Position/Affiliation
sousse 4031 Tunisia Farhat Hached University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available and will be shared from 6 months following the publication without end date. individuals and organizations who are engaged in scientific or scholarly research can request these details from Amani Kacem( kacem.amani@gmail.com )to achieve aims in the approved proposal. Statistical Analysis Plan As part of our IPD sharing plan, we will make the data collected in the study available in the protocol. Once the data collection phase is complete, interested researchers will have access to the raw, unprocessed data through the provided protocol. Additionally, we will share the statistical details related to the data analysis. The statistical details will be shared six months after publication. Access to the IPD and documents may be granted to individuals or entities engaged in scientific or scholarly research. Interested researchers or organizations must formally submit a request to amani kacem (kacem.amani@gmail.com). The request should include the purpose of the data usage, a detailed description of the proposed analyses, and any specific requirements. the request will be evaluated to assess the qualifications of the requester, the scientific merit of the proposed analyses, the potential benefits of sharing the data, and the adherence to ethical considerations, data protection, and privacy guidelines. qualifications of the requester, the scientific merit of the proposed analyses, the potential benefits of sharing the data, and the adherence to ethical considerations, data protection, and privacy guidelines. The documents, including study protocols, statistical details, and other relevant materials, will be made available as agreed upon
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information