Investigation of the Effects of Music on Anxiety During Operations Under Spinal Anaesthesia at an Hospital in Cambodia
NCT ID: NCT04169971
Last Updated: 2019-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2019-10-28
2019-12-02
Brief Summary
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Detailed Description
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Objectives: The primary objective is to determine the effects of intraoperative music on intraoperative anxiety levels for patients undergoing procedures conducted under spinal anaesthesia. The secondary objectives are to investigate whether participants feel that music improved/would improve their experience and whether they would choose it in future or recommend it for others.
Methods: This prospective randomised controlled trial will be conducted at the Children's Surgical Centre in Phnom Penh. Participants will be 18 years or over, due to undergo a procedure that requires spinal anaesthesia and not have a medical history that fulfils any of the exclusion criteria. The trial will aim to recruit between 16 and 28 patients consecutively once it commences, and participants will be randomised to either the music (M) group or the 'control' (C) group. The M group will receive music (pre-selected from 5 categories) played through headphones for the duration of the operation. The C group will receive no music or headphones. Anxiety will be measured in both groups, through a visual analogue scale (VAS), at the beginning of the operation and after 30 minutes of the procedure. In the recovery room the participants will be asked two questions relating to experience and future recommendations.
Results: The VAS scores and change in VAS scores will be displayed as mean ± Standard Error and the results from the two groups will be compared using a student's paired t-test or a Mann-Whitney U test depending on the distribution of the data. The results from the post-operation questions will be displayed as frequencies and the answers will be compared using a χ2 test. All tests will be 2-tailed and P\<0.05 will be considered significant
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Music group
Will receive music during the operation conducted under spinal anaesthesia
Music
Played through headphones during the operation under spinal anaesthesia
Control group
Will not receive music during the operation conducted under spinal anaesthesia
No interventions assigned to this group
Interventions
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Music
Played through headphones during the operation under spinal anaesthesia
Eligibility Criteria
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Inclusion Criteria
* Undergoing a procedure at CSC that requires spinal anaesthesia and spinal anaesthesia is not contra-indicated
* Gives informed consent to participate in the trial
Exclusion Criteria
* Has auditory impairment
* Deemed not to have capacity to give consent
* Sedatives are administered during the procedure
* General anaesthesia is required during the procedure
18 Years
ALL
No
Sponsors
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Children's Surgical Center, Cambodia
OTHER
Responsible Party
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Principal Investigators
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Joseph T Larvin, BMBCH
Role: PRINCIPAL_INVESTIGATOR
Children's Surgical Centre, Phnom Penh, Cambodia
SOKHALAY L SUOS, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Surgical Centre, Phnom Penh, Cambodia
Locations
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Children's Surgical Centre
Phnom Penh, , Cambodia
Countries
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References
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Other Identifiers
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musicduringspinal1
Identifier Type: -
Identifier Source: org_study_id