Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000855820
Ethics application status
Approved
Date submitted
13/08/2012
Date registered
14/08/2012
Date last updated
14/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does providing music before and during a colonoscopy reduce anxiety and influence the dose of anesthesia?
Scientific title
Music versus no music for anxiety and pain during colonoscopy
Secondary ID [1] 281014 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety before and after colonoscopy 287151 0
Pain during and after colonoscopy 287160 0
Condition category
Condition code
Oral and Gastrointestinal 287470 287470 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before the colonoscopy, patients were asked to fill out a short questionnaire of demographic information and about their anxiety prior to the procedure. Headphones were then be put on and the patient were able to adjust the volume. The patients were asked to concentrate on their breathing. The music was an hour or so of classical music chosen by one of the investigators with relevant qualifications in music and made as a loop so it would not stop during the procedure. The procedure itself can take anywhere between 20 and 45 minutes, depending on what is found, and recovery time is around two hours to ensure the sedation has worn off. The headphones remained on during the procedure and were removed upon completion of the procedure when patients were moved to the recovery suite.

The music was selected with the following in mind:
1. Tempo of music is more important than its genre. For music to be relaxing, its tempo should be lower than the heart beat (average 72 bpm). Relaxing function of music is achieved through slowing and deepening breathing, lowering blood pressure and muscle loosening (Bernardi, Porta & Sleight, 2006)
2. Music that is known to the listener is more relaxing and that’s why baroque music which is present in the media and widely known to general public was selected (Labbe, Schmidt, Babin & Pharr, 2007)
3. For music to be relaxing, it needs to be slow with breaks between musical notes and cannot be too loud, without sudden changes with regular pulsation (Reinhardt, 1999)
Intervention code [1] 285474 0
Other interventions
Comparator / control treatment
Patients in the control group were told that they are contributing to a study to investigate the anxiety and pain associated with a colonoscopy; therefore music was not mentioned. Headphones were placed on the patient before and remained on during the procedure with no music. They were told that this is to block out the noise of the busy unit.
Control group
Placebo

Outcomes
Primary outcome [1] 287739 0
anxiety
Timepoint [1] 287739 0
baseline and after the procedure measured on the State Trait Anxiety Inventory
Secondary outcome [1] 298739 0
pain
Timepoint [1] 298739 0
during and after the procedure as per the dose of sedation and Visual Analogue Scale

Eligibility
Key inclusion criteria
To be considered eligible for the study the patients had to:
1. Be undergoing a colonoscopy on the given day
2. Be at least 18 years of age
3. Have sufficient knowledge of English to understand and answer questions in a written format.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
To be considered ineligible for the study the patients had to:
1. Be suffering from a cognitive impairment (due to the nature of the questionnaire, a cognitive impairment would make the participant unable to understand and answer the questions accurately)
2. Be suffering from a hearing impairment that would affect their ability to listen to music via headphones.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were recruited from the RAH Gastroenterology booking list for colonoscopy. All patients were contacted via a letter, describing the study (patient information sheet), what is involved, the level of commitment required, and an invitation to participate in the study. The letter included an opt out slip for subjects who wish to not be contacted any further as well as a consent form for participants who want to be involved in the study. Patients were randomly allocated to either experimental (music) group or controls. The word ‘music’ was written on 20 pieces of paper and ‘non-music’ on another 20. On each day, prior to approaching any patients, a piece of paper was selected out of an envelope and this determined the group allocation for each day. Patients in both groups were told that they were contributing to a study to investigate the use of headphones on the anxiety, pain and overall experience of colonoscopy. The music group was also told that music would be playing through the headphones. This was to avoid the non-music group feeling they were receiving a lesser intervention, leading to a possible negative impact on their responses.

Patients were asked to fill out the demographic and anxiety questionnaires. Then, approximately 10 minutes before colonoscopy, the headphones were put on. The music group were able to adjust the volume and the non-music group were not plugged in to any device. The headphones remained on during colonoscopy and were removed upon completion.

After colonoscopy when the effects of sedation had subsided, patients were asked to complete the anxiety questionnaire again and also to complete a questionnaire on pain and overall experience. In some cases, if the patient was not feeling up to reading or did not have their glasses, the questions were read to them and answers transcribed by the researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by selecting a piece of paper from an envelope including 40 pieces of paper with words 'music'/'no music' written on them determined group allocation for participants on a given day.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A pilot, semi-randomised (since patients were randomised by days of the procedure) control trial was performed to determine the effect of music on anxiety and pain associated with colonoscopy and a patient’s willingness to repeat the procedure. Headphones were used in all subjects with the intervention group receiving music and the control group had the headphones muted during the procedure. Outcomes were assessed with quantitative measures and scales.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285804 0
Self funded/Unfunded
Name [1] 285804 0
Antonina Mikocka-Walus
Country [1] 285804 0
Australia
Primary sponsor type
Individual
Name
Antonina Mikocka-Walus
Address
University of South Australia, School of Nursing and Midwifery, GPO Box 2471, Adelaide 5001, SA
Country
Australia
Secondary sponsor category [1] 284629 0
Individual
Name [1] 284629 0
Fiona Martindale
Address [1] 284629 0
School of Psychology, Social Work and Social Policy, University of South Australia, Magil 5067, SA
Country [1] 284629 0
Australia
Secondary sponsor category [2] 284637 0
Individual
Name [2] 284637 0
Jane Andrews
Address [2] 284637 0
Department of Gastroenetrology and Hepatology, Royal Adelaide Hospital, Adelaide 5001, SA
Country [2] 284637 0
Australia
Other collaborator category [1] 277016 0
Individual
Name [1] 277016 0
Bartlomiej Walus
Address [1] 277016 0
Elder Conservatorium of Music, University of Adelaide, 5005, Adelaide, SA
Country [1] 277016 0
Australia
Other collaborator category [2] 277017 0
Individual
Name [2] 277017 0
Hannah Keage
Address [2] 277017 0
School of Psychology, Social Work and Social Policy, University of South Australia, Magil 5067, SA
Country [2] 277017 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287819 0
Royal Adelaide Hospital Resaecrh Ethics Committee and University of South Australia Research Ethics Committee
Ethics committee address [1] 287819 0
Ethics committee country [1] 287819 0
Australia
Date submitted for ethics approval [1] 287819 0
Approval date [1] 287819 0
18/05/2011
Ethics approval number [1] 287819 0
RAH REC ID: 110425 and UNISA REC: 0000024299

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34568 0
Address 34568 0
Country 34568 0
Phone 34568 0
Fax 34568 0
Email 34568 0
Contact person for public queries
Name 17815 0
Antonina Mikocka-Walus
Address 17815 0
UniSA, Nursing
GPO Box 2471, Adelaide 5001, SA
Country 17815 0
Australia
Phone 17815 0
+61883022468
Fax 17815 0
+61883022168
Email 17815 0
[email protected]
Contact person for scientific queries
Name 8743 0
Antonina Mikocka-Walus
Address 8743 0
UniSA, Nursing
GPO Box 2471, Adelaide 5001, SA
Country 8743 0
Australia
Phone 8743 0
+61883022468
Fax 8743 0
+61883022168
Email 8743 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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