Investigation of the Effects of Music on Anxiety During Operations Under Spinal Anaesthesia at an Hospital in Cambodia

December 18, 2019 updated by: Children's Surgical Center, Cambodia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cambodia
      • Phnom Penh, Cambodia
        • Children's Surgical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music group
Will receive music during the operation conducted under spinal anaesthesia
Other: Music
Played through headphones during the operation under spinal anaesthesia
No Intervention: Control group
Will not receive music during the operation conducted under spinal anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in intra-operative anxiety scores
Time Frame: Calculated between scores recorded at the start of the operation and 30 minutes into the procedure
Score on 'Anxiety visual analogue scale.' Minimum score 0 representing calm and maximum score 10 representing extreme anxiety
Calculated between scores recorded at the start of the operation and 30 minutes into the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patient's in the music group who felt that music made the experience better, worse or had no effect.
Time Frame: Within 4 hours post operation
Questionnaire asked verbally. What effect do you think music had on your experience during surgery? a) made it better b)made it worse c)no effect.
Within 4 hours post operation
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.
Time Frame: Within 4 hours post operation
Questionnaire asked verbally. Would you recommend listening to music during an operation to other people? a)yes b)no c) don't know
Within 4 hours post operation
Percentage of patient's in the control group who felt that music would have made their experience better, worse or the same.
Time Frame: Within 4 hours post operation
What effect do you think music would have had on your experience during surgery? a) made it better b)made it worse c)no effect.
Within 4 hours post operation
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.
Time Frame: Within 4 hours post operation
Questionnaire asked verbally. Would you like to listen to music if you were to have another operation? a)yes b)no c) don't know
Within 4 hours post operation
Percentage of anaesthetic providers that experience problems due to music.
Time Frame: Within 4 hours post operation
Questionnaire on data collection form. Do you think that the music caused any problems during the operation? a)yes b)no c)maybe
Within 4 hours post operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Surgical Center, Cambodia

Investigators

  • Principal Investigator: Joseph T Larvin, BMBCH, Children's Surgical Centre, Phnom Penh, Cambodia
  • Principal Investigator: SOKHALAY L SUOS, MD, Children's Surgical Centre, Phnom Penh, Cambodia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2019

Primary Completion (Actual)

December 2, 2019

Study Completion (Actual)

December 2, 2019

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

November 17, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

December 20, 2019

Last Update Submitted That Met QC Criteria

December 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • musicduringspinal1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

6 months after recruitment of last participant.

IPD Sharing Access Criteria

Requests will be reviewed by an independent review panel and all requestors will be required to sign a data access agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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