drugset / Trial / NCT03269929
Comparison Between Efficacy of Music Therapy and Intravenous Midazolam 0.02 mg/kgBW in Reducing Preoperative Anxiety
RandomizedParallel-groupQuadruple-blindSupportive care
Summary
This study aimed to compare the efficacy of music therapy and midazolam 0,02 mg/kgBW in reducing preoperative anxiety on patients undergoing brachytherapy with spinal anesthesia
Timeline
- Start
- 2017-01-01
- Primary completion
- 2017-03-31
- Completion
- 2017-07-01
Publications
- Background Mohd Fahmi Z, Lai LL, Loh PS. Validation of the Malay version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Med J Malaysia. 2015 Aug;70(4):243-8.
- Background Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Bandeira D, Ferreira MB. Risk factors for preoperative anxiety in adults. Acta Anaesthesiol Scand. 2001 Mar;45(3):298-307. doi: 10.1034/j.1399-6576.2001.045003298.x.
- Background Hyde R, Bryden F, Asbury AJ. How would patients prefer to spend the waiting time before their operations? Anaesthesia. 1998 Feb;53(2):192-5. doi: 10.1046/j.1365-2044.1998.00268.x.
- Background Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.
- Background Wright KD, Stewart SH, Finley GA, Buffett-Jerrott SE. Prevention and intervention strategies to alleviate preoperative anxiety in children: a critical review. Behav Modif. 2007 Jan;31(1):52-79. doi: 10.1177/0145445506295055.
- Background Griffin CE 3rd, Kaye AM, Bueno FR, Kaye AD. Benzodiazepine pharmacology and central nervous system-mediated effects. Ochsner J. 2013 Summer;13(2):214-23.
- Background Sun GC, Hsu MC, Chia YY, Chen PY, Shaw FZ. Effects of age and gender on intravenous midazolam premedication: a randomized double-blind study. Br J Anaesth. 2008 Nov;101(5):632-9. doi: 10.1093/bja/aen251. Epub 2008 Sep 4.
- Background Kain ZN, Sevarino F, Pincus S, Alexander GM, Wang SM, Ayoub C, Kosarussavadi B. Attenuation of the preoperative stress response with midazolam: effects on postoperative outcomes. Anesthesiology. 2000 Jul;93(1):141-7. doi: 10.1097/00000542-200007000-00024.
- Background Marwick C. Music therapists chime in with data on medical results. JAMA. 2000 Feb 9;283(6):731-3. No abstract available.
- Background Kamer S, Ozsaran Z, Celik O, Bildik O, Yalman D, Bolukbasi Y, Haydaroglu A. Evaluation of anxiety levels during intracavitary brachytherapy applications in women with gynecological malignancies. Eur J Gynaecol Oncol. 2007;28(2):121-4.
- Background Wetsch WA, Pircher I, Lederer W, Kinzl JF, Traweger C, Heinz-Erian P, Benzer A. Preoperative stress and anxiety in day-care patients and inpatients undergoing fast-track surgery. Br J Anaesth. 2009 Aug;103(2):199-205. doi: 10.1093/bja/aep136. Epub 2009 May 30.
- Background Mitchell M. Influence of gender and anaesthesia type on day surgery anxiety. J Adv Nurs. 2012 May;68(5):1014-25. doi: 10.1111/j.1365-2648.2011.05801.x. Epub 2011 Aug 2.
- Background Cooke M, Chaboyer W, Schluter P, Hiratos M. The effect of music on preoperative anxiety in day surgery. J Adv Nurs. 2005 Oct;52(1):47-55. doi: 10.1111/j.1365-2648.2005.03563.x.
- Background Bringman H, Giesecke K, Thorne A, Bringman S. Relaxing music as pre-medication before surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2009 Jul;53(6):759-64. doi: 10.1111/j.1399-6576.2009.01969.x. Epub 2009 Apr 14.
- Background Leardi S, Pietroletti R, Angeloni G, Necozione S, Ranalletta G, Del Gusto B. Randomized clinical trial examining the effect of music therapy in stress response to day surgery. Br J Surg. 2007 Aug;94(8):943-7. doi: 10.1002/bjs.5914.
- Background Bishop SJ. Neurocognitive mechanisms of anxiety: an integrative account. Trends Cogn Sci. 2007 Jul;11(7):307-16. doi: 10.1016/j.tics.2007.05.008. Epub 2007 Jun 5.
- Background Nigussie S, Belachew T, Wolancho W. Predictors of preoperative anxiety among surgical patients in Jimma University Specialized Teaching Hospital, South Western Ethiopia. BMC Surg. 2014 Sep 5;14:67. doi: 10.1186/1471-2482-14-67.
- Background Ploghaus A, Narain C, Beckmann CF, Clare S, Bantick S, Wise R, Matthews PM, Rawlins JN, Tracey I. Exacerbation of pain by anxiety is associated with activity in a hippocampal network. J Neurosci. 2001 Dec 15;21(24):9896-903. doi: 10.1523/JNEUROSCI.21-24-09896.2001.
- Background Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
- Background Kupietzky A, Houpt MI. Midazolam: a review of its use for conscious sedation of children. Pediatr Dent. 1993 Jul-Aug;15(4):237-41. No abstract available.
- Background Nordt SP, Clark RF. Midazolam: a review of therapeutic uses and toxicity. J Emerg Med. 1997 May-Jun;15(3):357-65. doi: 10.1016/s0736-4679(97)00022-x.
- Background Golparvar M, Saghaei M, Sajedi P, Razavi SS. Paradoxical reaction following intravenous midazolam premedication in pediatric patients - a randomized placebo controlled trial of ketamine for rapid tranquilization. Paediatr Anaesth. 2004 Nov;14(11):924-30. doi: 10.1111/j.1460-9592.2004.01349.x.
- Background Dundee JW, Halliday NJ, Harper KW, Brogden RN. Midazolam. A review of its pharmacological properties and therapeutic use. Drugs. 1984 Dec;28(6):519-43. doi: 10.2165/00003495-198428060-00002.
- Background Kemper KJ, Danhauer SC. Music as therapy. South Med J. 2005 Mar;98(3):282-8. doi: 10.1097/01.SMJ.0000154773.11986.39.
- Background Yinger OS, Gooding L. Music therapy and music medicine for children and adolescents. Child Adolesc Psychiatr Clin N Am. 2014 Jul;23(3):535-53. doi: 10.1016/j.chc.2013.03.003. Epub 2013 May 17.
- Background Nilsson U. The anxiety- and pain-reducing effects of music interventions: a systematic review. AORN J. 2008 Apr;87(4):780-807. doi: 10.1016/j.aorn.2007.09.013.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Midazolam | Small molecule | 0.02 mg/kg | Intravenous |