Clinical trial NCT04169971: Investigation of the Effects of Music on Anxiety During Operations Under Spinal Anaesthesia at an Hospital in Cambodia
Official title: A Prospective Randomised Controlled Trial to Investigate the Effects of Intra-operative Music on Anxiety Levels During Procedures Under Spinal Anaesthesia at a Surgical Centre in Cambodia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Anxiety
Keywords: trial
Anxiety
music
intraoperative period
spinal anaesthesia
Lead sponsor: Children's Surgical Center, Cambodia
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-centre, prospective, randomised controlled trial. Patients will be invited to participate if they are due to undergo a procedure for which they will require spinal anaesthesia and if they meet the inclusion criteria and none of the exclusion criteria. They will not be required to make any additional hospital visits and will be asked to give their informed consent prior to the procedure. Half of the participants will receive music from the start of surgery until completion of the operation and the other half will serve as the 'control group' and will receive no headphones or music. The anxiety of participant's during the operation will be assessed through a VAS and they will be asked questions about their experience afterwards. The anxiety scores from the two groups will be compared, as will their responses to the questions about their experience, in order to elucidate whether the music produced any differences in anxiety or experience.
Primary purpose: PREVENTION

Brief summary: This study investigates he effects of intra-operative music on anxiety levels during procedures under spinal anaesthesia at a surgical centre in Cambodia. Participants will be randomly allocated to either the music (M) group or the 'control' (C) group. The M group will receive music 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. Scores will be compared.

Detailed description: Background: During operations conducted under spinal anaesthesia patients are aware of their environment, including sounds related to operative instruments and the voices of staff. This has the potential to cause anxiety and amplify existing anxiety which can negatively impact patient experience and outcomes. Research has shown peri-operative music can reduce anxiety but there is no robust evidence for the effect of intraoperative music on intraoperative anxiety.

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

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* 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 an existing psychological diagnosis
* Has auditory impairment
* Deemed not to have capacity to give consent
* Sedatives are administered during the procedure
* General anaesthesia is required during the procedure

Primary outcomes:
measure: Change in intra-operative anxiety scores
timeFrame: Calculated between scores recorded at the start of the operation and 30 minutes into the procedure
Secondary outcomes:
measure: Percentage of patient's in the music group who felt that music made the experience better, worse or had no effect.
timeFrame: Within 4 hours post operation
measure: Percentage of patient's in the music group who felt that they would recommend to others, wouldn't recommend to others or did not know.
timeFrame: Within 4 hours post operation
measure: Percentage of patient's in the control group who felt that music would have made their experience better, worse or the same.
timeFrame: Within 4 hours post operation
measure: Percentage of patient's in the music group who, if they had another operation, would like to listen to music, would not like to listen to music, or did not know.
timeFrame: Within 4 hours post operation
measure: Percentage of anaesthetic providers that experience problems due to music.
timeFrame: Within 4 hours post operation
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: Children's Surgical Centre
Study officials:
affiliation: Children's Surgical Centre, Phnom Penh, Cambodia
name: Joseph T Larvin, BMBCH
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Surgical Centre, Phnom Penh, Cambodia
name: SOKHALAY L SUOS, MD
role: PRINCIPAL_INVESTIGATOR
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