Investigation of the Effects of Music on Anxiety During Operations Under Spinal Anaesthesia at an Hospital in Cambodia
18 de dezembro de 2019 atualizado por: 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.
Visão geral do estudo
Descrição detalhada
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
Tipo de estudo
Intervencional
Inscrição (Real)
24
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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-
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Phnom Penh, Camboja
- Children's Surgical Centre
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Music group
Will receive music during the operation conducted under spinal anaesthesia
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Played through headphones during the operation under spinal anaesthesia
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Sem intervenção: Control group
Will not receive music during the operation conducted under spinal anaesthesia
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in intra-operative anxiety scores
Prazo: Calculated between scores recorded at the start of the operation and 30 minutes into the procedure
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Score on 'Anxiety visual analogue scale.'
Minimum score 0 representing calm and maximum score 10 representing extreme anxiety
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Calculated between scores recorded at the start of the operation and 30 minutes into the procedure
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of patient's in the music group who felt that music made the experience better, worse or had no effect.
Prazo: Within 4 hours post operation
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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.
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Within 4 hours post operation
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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.
Prazo: Within 4 hours post operation
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Questionnaire asked verbally.
Would you recommend listening to music during an operation to other people?
a)yes b)no c) don't know
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Within 4 hours post operation
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Percentage of patient's in the control group who felt that music would have made their experience better, worse or the same.
Prazo: Within 4 hours post operation
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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.
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Within 4 hours post operation
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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.
Prazo: Within 4 hours post operation
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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
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Within 4 hours post operation
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Percentage of anaesthetic providers that experience problems due to music.
Prazo: Within 4 hours post operation
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Questionnaire on data collection form.
Do you think that the music caused any problems during the operation?
a)yes b)no c)maybe
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Within 4 hours post operation
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Joseph T Larvin, BMBCH, Children's Surgical Centre, Phnom Penh, Cambodia
- Investigador principal: SOKHALAY L SUOS, MD, Children's Surgical Centre, Phnom Penh, Cambodia
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- 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. doi: 10.1046/j.1365-2044.2001.01842.x.
- Wilson 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.
- Jlala 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.
- Wu 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.
- Zengin 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.
- Costa 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.
- 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.
- 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.
- Wang 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.
- 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.
- 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.
- 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.
- Lepage 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.
- Maeyama A, Kodaka M, Miyao H. [Effect of the music-therapy under spinal anesthesia]. Masui. 2009 Jun;58(6):684-91. Japanese.
- Elkins G, Staniunas R, Rajab MH, Marcus J, Snyder T. Use of a numeric visual analog anxiety scale among patients undergoing colorectal surgery. Clin Nurs Res. 2004 Aug;13(3):237-44. doi: 10.1177/1054773803262222.
- Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036.
- 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.
- Alfredsson M, San Sebastian M, Jeghannathan B. Attitudes towards mental health and the integration of mental health services into primary health care: a cross-sectional survey among health-care workers in Lvea Em District, Cambodia. Glob Health Action. 2017;10(1):1331579. doi: 10.1080/16549716.2017.1331579.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
28 de outubro de 2019
Conclusão Primária (Real)
2 de dezembro de 2019
Conclusão do estudo (Real)
2 de dezembro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
31 de outubro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de novembro de 2019
Primeira postagem (Real)
20 de novembro de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de dezembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de dezembro de 2019
Última verificação
1 de novembro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- musicduringspinal1
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Sim
Descrição do plano IPD
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Prazo de Compartilhamento de IPD
6 months after recruitment of last participant.
Critérios de acesso de compartilhamento IPD
Requests will be reviewed by an independent review panel and all requestors will be required to sign a data access agreement.
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
- Plano de Análise Estatística (SAP)
- Termo de Consentimento Livre e Esclarecido (TCLE)
- Relatório de Estudo Clínico (CSR)
- Código Analítico
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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