Crossover clinical trial of pain relief in cataract surgery

Suvin Choi, Sang-Gue Park, Lorne Bellan, Hyung-Hwan Lee, Sung Kun Chung, Suvin Choi, Sang-Gue Park, Lorne Bellan, Hyung-Hwan Lee, Sung Kun Chung

Abstract

Purpose: To determine the effects of intra-operative Korean traditional music on pain experienced by Korean patients undergoing sequential bilateral cataract surgery.

Methods: This was a two-sequence, two-period, and two-treatment crossover study. Fifty-two patients with cataracts were divided into two groups by block randomization, and bilateral cataract surgery was performed. In group 1, patients listened to Korean traditional music (KTM) during their first but not second cataract surgery. This sequence was reversed for patients in group 2. After each surgery, patients scored their pain intensity (PI) using a visual analog scale (VAS) ranging from 0 to 10, where 0 was 'no pain' and 10 was 'unbearable pain.'

Result: There was a statistically significant reduction in the mean VAS score with KTM (3.1 ± 2.0) compared to that without KTM (4.1 ± 2.2; p = 0.013). However, there were no statistically significant differences in blood pressure or pulse rates.

Conclusion: KTM had a significant effect on reducing pain experienced by patients during cataract surgery. This may be useful in the context of other surgical procedures to reduce pain in Korean patients.

Keywords: Adjuvant therapy; Cataract surgery; Crossover design; Pain; Washout period.

Conflict of interest statement

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in this study.

Figures

Fig. 1
Fig. 1
Two-sequence, two-period, and two-treatment crossover design

References

    1. Bellan L. The evolution of cataract surgery: the most common eye procedure in older adults. Geriatr Aging. 2008;11(6):328–332.
    1. Yoo C-U, Lee H-J, Yang Y-A. Common diseases in the elderly—data from Korea National Statistical Office. J Korean Assoc Occup Therapy Policy Aged Ind. 2013;5:39–45.
    1. Haddadi S, Marzban S, Fazeli B, Heidarzadeh A, Parvizi A, Naderinabi B, Panah MRP. Comparing the effect of topical anesthesia and retrobulbar block with intravenous sedation on hemodynamic changes and satisfaction in patients undergoing cataract surgery (Phaco method) Anesthesiol Pain Med. 2015
    1. Kanonidou Z, Karystianou G. Anesthesia for the elderly. Hippokratia. 2007;11(4):175.
    1. Bellan L, Gooi A, Rehsia S. The Misericordia Health Centre cataract comfort study. Can J Ophthalmol/J Can d’Ophtalmol. 2002;37(3):155–160. doi: 10.1016/S0008-4182(02)80057-6.
    1. Ursea R, Feng MT, Zhou M, Lien V, Loeb R. Pain perception in sequential cataract surgery: comparison of first and second procedures. J Cataract Refract Surg. 2011;37(6):1009–1014. doi: 10.1016/j.jcrs.2011.01.020.
    1. Habib NE, Mandour NM, Balmer HG. Effect of midazolam on anxiety level and pain perception in cataract surgery with topical anesthesia. J Cataract Refract Surg. 2004;30(2):437–443. doi: 10.1016/S0886-3350(03)00557-1.
    1. Harman DM. Combined sedation and topical anesthesia for cataract surgery. J Cataract Refract Surg. 2000;26(1):109–113. doi: 10.1016/S0886-3350(99)00330-2.
    1. Bringman H, Giesecke K, Thörne A, Bringman S. Relaxing music as pre-medication before surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2009;53(6):759–764. doi: 10.1111/j.1399-6576.2009.01969.x.
    1. Özer N, Karaman Özlü Z, Arslan S, Günes N. Effect of music on postoperative pain and physiologic parameters of patients after open heart surgery. Pain Manag Nurs. 2013;14(1):20–28. doi: 10.1016/j.pmn.2010.05.002.
    1. Boer D, Abubakar A. Music listening in families and peer groups: benefits for young people’s social cohesion and emotional well-being across four cultures. Front Psychol. 2014;5:392. doi: 10.3389/fpsyg.2014.00392.
    1. Nilsson U, Rawal N, Uneståhl LE, Zetterberg C, Unosson M. Improved recovery after music and therapeutic suggestions during general anaesthesia: a double-blind randomised controlled trial. Acta Anaesthesiol Scand. 2001;45(7):812–817. doi: 10.1034/j.1399-6576.2001.045007812.x.
    1. Shue B, Chatterjee A, Fudemberg S, Katz LJ, Moster MR, Navarro MJ, Pro M, Schmidt C, Spaeth GL, Stirbu O. The effects of Mozart’s music on the Performance of glaucoma patients on automated perimetry. Invest Ophthalmol Vis Sci. 2011;52(10):7347–7349. doi: 10.1167/iovs.11-7430.
    1. Chen X, Seth RK, Rao VS, Huang JJ, Adelman RA. Effects of music therapy on intravitreal injections: a randomized clinical trial. J Ocul Pharmacol Ther. 2012;28(4):414–419. doi: 10.1089/jop.2011.0257.
    1. Merakou K, Varouxi G, Barbouni A, Antoniadou E, Karageorgos G, Theodoridis D, Koutsouri A, Kourea-Kremastinou J. Blood pressure and heart rate alterations through music in patients undergoing cataract surgery in Greece. Ophthalmol Eye Dis. 2015;7:7. doi: 10.4137/OED.S20960.
    1. Cruise CJ, Chung F, Yogendran S, Little DA. Music increases satisfaction in elderly outpatients undergoing cataract surgery. Can J Anaesth. 1997;44(1):43–48. doi: 10.1007/BF03014323.
    1. Park SG. Statistical methods for bioequivalence trials. Paju: Freedom Academy; 2014.
    1. Wellek S, Blettner M. On the proper use of the crossover design in clinical trials: part 18 of a series on evaluation of scientific publications. Dtsch Ärztebl Int. 2012;109(15):276.
    1. Yoon KC, Cho C-H, Seo M-S, Yang K-J. Comparision of ocular pain between topical and retrobulbar anesthesia for cataract surgery. J Korean Ophthalmol Soc. 1996;37(12):2041–2047.
    1. Lee JS, Chung SK, Baek NH. Topical versus retrobulbar anesthesia in clear corneal cataract surgery. J Korean Ophthalmol Soc. 1999;40(11):3031–3037.
    1. Jiang L, Zhang K, He W, Zhu X, Zhou P, Lu Y. Perceived pain during cataract surgery with topical anesthesia: a comparison between first-eye and second-eye surgery. J Ophthalmol. 2015
    1. Bardocci A, Ciucci F, Lofoco G, Perdicaro S, Lischetti A. Pain during second eye cataract surgery under topical anesthesia: an intraindividual study. Graefe’s Arch Clin Exp Ophthalmol. 2011;249(10):1511–1514. doi: 10.1007/s00417-011-1803-9.
    1. Ko JS, Ahn JM, Seo KY, Kim EK, Kim TI. Relationship between cataract maturation and pain scale during cataract surgery under topical anesthesia. J Korean Ophthalmol Soc. 2013;54(3):437–442. doi: 10.3341/jkos.2013.54.3.437.
    1. Aslankurt M, Aslan L, Başkan AM, Aksoy A, Silay E, Yıldız H. Pain and cooperation in patients having dominant-side or nondominant-side phacoemulsification. J Cataract Refract Surg. 2014;40(2):199–202. doi: 10.1016/j.jcrs.2013.07.038.
    1. Alhashemi J. Dexmedetomidine vs midazolam for monitored anaesthesia care during cataract surgery. Br J Anaesth. 2006;96(6):722–726. doi: 10.1093/bja/ael080.
    1. Au Eong K-G, Low C-H, Heng W-J, Aung T, Lim T-H, Ho S-H, Yong VSH. Subjective visual experience during phacoemulsification and intraocular lens implantation under topical anesthesia1. Ophthalmology. 2000;107(2):248–250. doi: 10.1016/S0161-6420(99)00080-9.
    1. Nilsson U. Soothing music can increase oxytocin levels during bed rest after open-heart surgery: a randomised control trial. J Clin Nurs. 2009;18(15):2153–2161. doi: 10.1111/j.1365-2702.2008.02718.x.
    1. Ovayolu N, Ucan O, Pehlivan S, Pehlivan Y, Buyukhatipoglu H, Savas MC. Listening to Turkish classical music decreases patients’ anxiety, pain, dissatisfaction and the dose of sedative and analgesic drugs during colonoscopy: a prospective randomized controlled trial. World J Gastroenterol. 2006;12(46):7532–7536. doi: 10.3748/wjg.v12.i46.7532.
    1. Choi YK, Hwang J-S, McMillan SJ. Gearing up for mobile advertising: a cross-cultural examination of key factors that drive mobile messages home to consumers. Psychol Mark. 2008;25(8):756–768. doi: 10.1002/mar.20237.
    1. Korea National Health & Nutrition Examination Survey, Korea Center For Disease Control and Prevention. . Accessed 26 Oct 2015

Source: PubMed

3
订阅