SurgeryNCT04169971
Investigation of the Effects of Music on Anxiety During Operations Under Spinal Anaesthesia at an Hospital in Cambodia
A study testing Music in people with Surgery and Anxiety, run by Children's Surgical Center, Cambodia at 1 site in Cambodia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCambodia
- Study dates
- 28 Oct 2019to 2 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Music
- Keywords
- trial, Anxiety, music, intraoperative period, spinal anaesthesia
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Played through headphones during the operation under spinal anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Music group | Experimental | Will receive music during the operation conducted under spinal anaesthesia Receives: Other: Music |
| Control group | No intervention | Will not receive music during the operation conducted under spinal anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intra-operative anxiety scores
Score on 'Anxiety visual analogue scale.' Minimum score 0 representing calm and maximum score 10 representing extreme anxiety
Measured: Calculated between scores recorded at the start of the operation and 30 minutes into the procedure
Secondary outcomes (5)
Percentage of patient's in the music group who felt that music made the experience better, worse or had no effect.
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.
Measured: 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.
Questionnaire asked verbally. Would you recommend listening to music during an operation to other people? a)yes b)no c) don't know
Measured: 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.
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.
Measured: 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.
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
Measured: Within 4 hours post operation
Percentage of anaesthetic providers that experience problems due to music.
Questionnaire on data collection form. Do you think that the music caused any problems during the operation? a)yes b)no c)maybe
Measured: Within 4 hours post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start28 Oct 2019
- Primary completion2 Dec 2019
- Study completion2 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Surgical Center, Cambodia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph T Larvin, BMBCH, Principal investigator, Children's Surgical Centre, Phnom Penh, CambodiaSOKHALAY L SUOS, MD, Principal investigator, Children's Surgical Centre, Phnom Penh, Cambodia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169971
- Sponsor's protocol ID
- musicduringspinal1
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Norris W, Baird WL. Pre-operative anxiety: a study of the incidence and aetiology. Br J Anaesth. 1967 Jun;39(6):503-9. doi: 10.1093/bja/39.6.503. No abstract available.
PubMed 6027959Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Adamatti LC, Bandeira D, Ferreira MB. Risk factors for postoperative anxiety in adults. Anaesthesia. 2001 Aug;56(8):720-8. doi: 10.1046/j.1365-2044.2001.01842.x.
PubMed 11493233Wilson CJ, Mitchelson AJ, Tzeng TH, El-Othmani MM, Saleh J, Vasdev S, LaMontagne HJ, Saleh KJ. Caring for the surgically anxious patient: a review of the interventions and a guide to optimizing surgical outcomes. Am J Surg. 2016 Jul;212(1):151-9. doi: 10.1016/j.amjsurg.2015.03.023. Epub 2015 Jun 2.
PubMed 26138522Jlala HA, Bedforth NM, Hardman JG. Anesthesiologists' perception of patients' anxiety under regional anesthesia. Local Reg Anesth. 2010;3:65-71. doi: 10.2147/lra.s11271. Epub 2010 Aug 12.
PubMed 22915871Wu PY, Huang ML, Lee WP, Wang C, Shih WM. Effects of music listening on anxiety and physiological responses in patients undergoing awake craniotomy. Complement Ther Med. 2017 Jun;32:56-60. doi: 10.1016/j.ctim.2017.03.007. Epub 2017 Mar 31.
PubMed 28619305Zengin S, Kabul S, Al B, Sarcan E, Dogan M, Yildirim C. Effects of music therapy on pain and anxiety in patients undergoing port catheter placement procedure. Complement Ther Med. 2013 Dec;21(6):689-96. doi: 10.1016/j.ctim.2013.08.017. Epub 2013 Sep 1.
PubMed 24280479Costa A, Montalbano LM, Orlando A, Ingoglia C, Linea C, Giunta M, Mancuso A, Mocciaro F, Bellingardo R, Tine F, D'Amico G. Music for colonoscopy: A single-blind randomized controlled trial. Dig Liver Dis. 2010 Dec;42(12):871-6. doi: 10.1016/j.dld.2010.03.016. Epub 2010 May 7.
PubMed 20452299Pittman S, Kridli S. Music intervention and preoperative anxiety: an integrative review. Int Nurs Rev. 2011 Jun;58(2):157-63. doi: 10.1111/j.1466-7657.2011.00888.x. Epub 2011 Feb 15.
PubMed 21554287Tan X, Yowler CJ, Super DM, Fratianne RB. The efficacy of music therapy protocols for decreasing pain, anxiety, and muscle tension levels during burn dressing changes: a prospective randomized crossover trial. J Burn Care Res. 2010 Jul-Aug;31(4):590-7. doi: 10.1097/BCR.0b013e3181e4d71b.
PubMed 20498613Wang SM, Kulkarni L, Dolev J, Kain ZN. Music and preoperative anxiety: a randomized, controlled study. Anesth Analg. 2002 Jun;94(6):1489-94, table of contents. doi: 10.1097/00000539-200206000-00021.
PubMed 12032013McClurkin SL, Smith CD. The Duration of Self-Selected Music Needed to Reduce Preoperative Anxiety. J Perianesth Nurs. 2016 Jun;31(3):196-208. doi: 10.1016/j.jopan.2014.05.017. Epub 2016 Feb 24.
PubMed 27235956Mingir T, Ervatan Z, Turgut N. Spinal Anaesthesia and Perioperative Anxiety. Turk J Anaesthesiol Reanim. 2014 Aug;42(4):190-5. doi: 10.5152/TJAR.2014.99705. Epub 2014 May 29.
PubMed 27366419Lee WP, Wu PY, Lee MY, Ho LH, Shih WM. Music listening alleviates anxiety and physiological responses in patients receiving spinal anesthesia. Complement Ther Med. 2017 Apr;31:8-13. doi: 10.1016/j.ctim.2016.12.006. Epub 2017 Jan 7.
PubMed 28434475Lepage C, Drolet P, Girard M, Grenier Y, DeGagne R. Music decreases sedative requirements during spinal anesthesia. Anesth Analg. 2001 Oct;93(4):912-6. doi: 10.1097/00000539-200110000-00022.
PubMed 11574356Maeyama A, Kodaka M, Miyao H. [Effect of the music-therapy under spinal anesthesia]. Masui. 2009 Jun;58(6):684-91. Japanese.
PubMed 19522258
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04169971
- Acronym / sponsor ID
- musicduringspinal1
- Keywords
- trial, Anxiety, music, intraoperative period, spinal anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Children's Surgical Center, CambodiaUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Other: MusicWill receive music during the operation conducted under spinal anaesthesia |
| Control group | No intervention | –Will not receive music during the operation conducted under spinal anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicPlayed through headphones during the operation under spinal anaesthesia | Other | Music group |
Primary outcome
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
5 secondary outcomes
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
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
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
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
Percentage of anaesthetic providers that experience problems due to music.
Time frame: Within 4 hours post operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Background: PubMed 6027959Norris W, Baird WL. Pre-operative anxiety: a study of the incidence and aetiology. Br J Anaesth. 1967 Jun;39(6):503-9. doi: 10.1093/bja/39.6.503. No abstract available.
- Background: PubMed 11493233Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Adamatti LC, Bandeira D, Ferreira MB. Risk factors for postoperative anxiety in adults. Anaesthesia. 2001 Aug;56(8):720-8. doi: 10.1046/j.1365-2044.2001.01842.x.
- Background: PubMed 26138522Wilson CJ, Mitchelson AJ, Tzeng TH, El-Othmani MM, Saleh J, Vasdev S, LaMontagne HJ, Saleh KJ. Caring for the surgically anxious patient: a review of the interventions and a guide to optimizing surgical outcomes. Am J Surg. 2016 Jul;212(1):151-9. doi: 10.1016/j.amjsurg.2015.03.023. Epub 2015 Jun 2.
- Background: PubMed 22915871Jlala HA, Bedforth NM, Hardman JG. Anesthesiologists' perception of patients' anxiety under regional anesthesia. Local Reg Anesth. 2010;3:65-71. doi: 10.2147/lra.s11271. Epub 2010 Aug 12.
- Background: PubMed 28619305Wu PY, Huang ML, Lee WP, Wang C, Shih WM. Effects of music listening on anxiety and physiological responses in patients undergoing awake craniotomy. Complement Ther Med. 2017 Jun;32:56-60. doi: 10.1016/j.ctim.2017.03.007. Epub 2017 Mar 31.
- Background: PubMed 24280479Zengin S, Kabul S, Al B, Sarcan E, Dogan M, Yildirim C. Effects of music therapy on pain and anxiety in patients undergoing port catheter placement procedure. Complement Ther Med. 2013 Dec;21(6):689-96. doi: 10.1016/j.ctim.2013.08.017. Epub 2013 Sep 1.
- Background: PubMed 20452299Costa A, Montalbano LM, Orlando A, Ingoglia C, Linea C, Giunta M, Mancuso A, Mocciaro F, Bellingardo R, Tine F, D'Amico G. Music for colonoscopy: A single-blind randomized controlled trial. Dig Liver Dis. 2010 Dec;42(12):871-6. doi: 10.1016/j.dld.2010.03.016. Epub 2010 May 7.
- Background: PubMed 21554287Pittman S, Kridli S. Music intervention and preoperative anxiety: an integrative review. Int Nurs Rev. 2011 Jun;58(2):157-63. doi: 10.1111/j.1466-7657.2011.00888.x. Epub 2011 Feb 15.
- Background: PubMed 20498613Tan X, Yowler CJ, Super DM, Fratianne RB. The efficacy of music therapy protocols for decreasing pain, anxiety, and muscle tension levels during burn dressing changes: a prospective randomized crossover trial. J Burn Care Res. 2010 Jul-Aug;31(4):590-7. doi: 10.1097/BCR.0b013e3181e4d71b.
- Background: PubMed 12032013Wang SM, Kulkarni L, Dolev J, Kain ZN. Music and preoperative anxiety: a randomized, controlled study. Anesth Analg. 2002 Jun;94(6):1489-94, table of contents. doi: 10.1097/00000539-200206000-00021.
- Background: PubMed 27235956McClurkin SL, Smith CD. The Duration of Self-Selected Music Needed to Reduce Preoperative Anxiety. J Perianesth Nurs. 2016 Jun;31(3):196-208. doi: 10.1016/j.jopan.2014.05.017. Epub 2016 Feb 24.
- Background: PubMed 27366419Mingir T, Ervatan Z, Turgut N. Spinal Anaesthesia and Perioperative Anxiety. Turk J Anaesthesiol Reanim. 2014 Aug;42(4):190-5. doi: 10.5152/TJAR.2014.99705. Epub 2014 May 29.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph T Larvin, BMBCH principal investigator
Children's Surgical Centre, Phnom Penh, Cambodia
SOKHALAY L SUOS, MD principal investigator
Children's Surgical Centre, Phnom Penh, Cambodia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Surgery and Anxiety, run by Children's Surgical Center, Cambodia at 1 site in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intra-operative anxiety scores (time frame: Calculated between scores recorded at the start of the operation and 30 minutes into the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04169971, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.