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

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169971
• Other study ID #: musicduringspinal1
• Status: Completed
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: December 2, 2019

Study information

• Verified date: November 2019
• Source: Children's Surgical Center, Cambodia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2, 2019
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Surgery

Intervention

Other:
• Music
Played through headphones during the operation under spinal anaesthesia

Locations

Country	Name	City	State
Cambodia	Children's Surgical Centre	Phnom Penh

Sponsors (1)

Lead Sponsor	Collaborator
Children's Surgical Center, Cambodia

Country where clinical trial is conducted

Cambodia, 

References & Publications (19)

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Caumo 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. — View Citation

Costa A, Montalbano LM, Orlando A, Ingoglia C, Linea C, Giunta M, Mancuso A, Mocciaro F, Bellingardo R, Tinè 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. — View Citation

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Lee 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. — View Citation

Lepage C, Drolet P, Girard M, Grenier Y, DeGagné R. Music decreases sedative requirements during spinal anesthesia. Anesth Analg. 2001 Oct;93(4):912-6. — View Citation

Maeyama A, Kodaka M, Miyao H. [Effect of the music-therapy under spinal anesthesia]. Masui. 2009 Jun;58(6):684-91. Japanese. — View Citation

McClurkin 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. — View Citation

Mingir 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. — View Citation

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Pittman 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. Review. — View Citation

Seponski DM, Lahar CJ, Khann S, Kao S, Schunert T. Four decades following the Khmer rouge: sociodemographic factors impacting depression, anxiety and PTSD in Cambodia. J Ment Health. 2019 Apr;28(2):175-180. doi: 10.1080/09638237.2018.1466039. Epub 2018 May 7. — View Citation

Tan 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. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intra-operative anxiety scores	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	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.	Within 4 hours post operation
Secondary	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	Within 4 hours post operation
Secondary	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.	Within 4 hours post operation
Secondary	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	Within 4 hours post operation
Secondary	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	Within 4 hours post operation