Clinical trial NCT04595253: The Effectiveness of Acupressure for Managing Postoperative Pain and Anxiety in Patients With Thoracoscopic Surgery
Official title: Professor, School of Nursing, China Medical University Hospital, Principal Investigator
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Diseases
Keywords: acupressure
thoracoscopic surgery
acute pain
anxiety
comfort
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: China Medical University Hospital
First posted: 2020-10-20
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to explore the effectiveness of acupressure for managing postoperative pain, anxiety, analgesia consumption, early ambulation, and comfort in patients with thoracoscopic surgery.

Detailed description: Thoracoscopic surgery is the surgical used to removal of a section or a segment of a lung lobe. One US national survey reported that 80% of patients undergoing pulmonary surgery experienced acute pain. 75-86% of these patients pointed out that experienced moderate, severe, or extreme pain, especially, on the 1st day after thoracoscopic surgery. However, inappropriate pain management after surgery is associated with limited the healing process, increased workload of heart, prolonged pulmonary rehabilitation, and increased medical costs, and can be a prediction of developing chronic pain. Acupressure is a nonpharmacological treatment for the management of postoperative pain. Recent studies have found that the application of acupressure is effective in decreasing operative pain intensity, morphine related side effects, and opioid consumptions after surgery. However, there was no further research about the role of acupressure applied to thoracoscopic surgery.

Eligibility criteria: Inclusion Criteria:

* pulmonary lung disease and will be scheduled to undergo a thoracoscopic wedge resection, segmentectomy, or lobectomy.
* American Society of Anesthesiologist physical status of Classes I-II,
* both forearms without missing limbs or arteriovenous fistula
* ability to communicate in Taiwanese or Chinese, and
* agreement to participate in this study.

Exclusion Criteria:

* diagnosed as malignant neoplasm with lung meta,
* Had a stroke or peripheral vascular disease
* Platelet count less than 20 x 10\^3/mm\^3
* Using the patient controlled analgesia, and
* any known mental illness or memory dysfunction.

Primary outcomes:
measure: Pain:Changes from baseline pain scale at post-operative day 2, after intervention.
timeFrame: Measure at before operation day, 7 post meridiem (PM), before operation; post-operative day1, 8 ante meridiem (AM), before intervention; post-operative day 1, 5 PM, after intervention; and post-operative day 2, 5 PM, after intervention
Secondary outcomes:
measure: Anxiety
timeFrame: Measure at before operation day, 7 post meridiem (PM), before operation; post-operative day1, 9 ante meridiem (AM), before intervention; post-operative day 1, 5 PM, after intervention; and post-operative day 2, 5 PM, after intervention.
measure: Anxiety
timeFrame: Time Frame: Measure at before operation day, 7 post meridiem (PM), before operation; post-operative day1, 8 ante meridiem (AM), before intervention; and post-operative day 2, post meridiem (PM), after intervention.
Other outcomes:
measure: Analgesia Consumption
timeFrame: during the whole admission, an average of 4 day.
measure: Comfort
timeFrame: Measure at before operation day,7 post meridiem (PM), before operation; post-operative day 1, 8 ante meridiem (AM), before intervention; and post-operative day 2, 5pm, after intervention
measure: Heart rate variability
timeFrame: Measure at before operation day, 7 post meridiem (PM), before operation; post-operative day1, 8 ante meridiem (PM), before intervention; post-operative day 1, 5 post meridiem (PM), after intervention; and post-operative day 2, 5 PM, after intervention.
measure: Early ambulation
timeFrame: The first ambulation time after operation would be recorded, assessed up to 7 days.
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
affiliation: China Medical University, China
name: Wei-Fen Ma, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amico, T. A. D. (2007). Thoracoscopic Lobectomy. Journal of Medical Sciences, 27(3), 95-100. https://doi.org/10.6136/JMS.2007.27(3).095
citation: Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
citation: Au DW, Tsang HW, Ling PP, Leung CH, Ip PK, Cheung WM. Effects of acupressure on anxiety: a systematic review and meta-analysis. Acupunct Med. 2015 Oct;33(5):353-9. doi: 10.1136/acupmed-2014-010720. Epub 2015 May 22.
citation: Batvani M, Yousefi H, Valiani M, Shahabi J, Mardanparvar H. The Effect of Acupressure on Physiological Parameters of Myocardial Infarction Patients: A Randomized Clinical Trial. Iran J Nurs Midwifery Res. 2018 Mar-Apr;23(2):143-148. doi: 10.4103/ijnmr.IJNMR_83_16.
citation: Boker A, Brownell L, Donen N. The Amsterdam preoperative anxiety and information scale provides a simple and reliable measure of preoperative anxiety. Can J Anaesth. 2002 Oct;49(8):792-8. doi: 10.1007/BF03017410.
citation: Chang LH, Hsu CH, Jong GP, Ho S, Tsay SL, Lin KC. Auricular acupressure for managing postoperative pain and knee motion in patients with total knee replacement: a randomized sham control study. Evid Based Complement Alternat Med. 2012;2012:528452. doi: 10.1155/2012/528452. Epub 2012 Jul 10.
citation: Chang S. The meridian system and mechanism of acupuncture: a comparative review. Part 3: Mechanisms of acupuncture therapies. Taiwan J Obstet Gynecol. 2013 Jun;52(2):171-84. doi: 10.1016/j.tjog.2013.04.005.
citation: Chang S. The meridian system and mechanism of acupuncture-a comparative review. Part 1: the meridian system. Taiwan J Obstet Gynecol. 2012 Dec;51(4):506-14. doi: 10.1016/j.tjog.2012.09.004.
citation: Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b.
citation: Chen T, Wang K, Xu J, Ma W, Zhou J. Electroacupuncture Reduces Postoperative Pain and Analgesic Consumption in Patients Undergoing Thoracic Surgery: A Randomized Study. Evid Based Complement Alternat Med. 2016;2016:2126416. doi: 10.1155/2016/2126416. Epub 2016 Mar 17.
citation: Coutaux A. Non-pharmacological treatments for pain relief: TENS and acupuncture. Joint Bone Spine. 2017 Dec;84(6):657-661. doi: 10.1016/j.jbspin.2017.02.005. Epub 2017 Feb 20.
citation: Danoff JR, Goel R, Sutton R, Maltenfort MG, Austin MS. How Much Pain Is Significant? Defining the Minimal Clinically Important Difference for the Visual Analog Scale for Pain After Total Joint Arthroplasty. J Arthroplasty. 2018 Jul;33(7S):S71-S75.e2. doi: 10.1016/j.arth.2018.02.029. Epub 2018 Feb 22.
citation: Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
citation: Endler NS, Kocovski NL. State and trait anxiety revisited. J Anxiety Disord. 2001 May-Jun;15(3):231-45. doi: 10.1016/s0887-6185(01)00060-3.
citation: Engen DJ, Carns PE, Allen MS, Bauer BA, Loehrer LL, Cha SS, Chartrand CM, Eggler EJ, Cutshall SM, Wahner-Roedler DL. Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial. Complement Ther Clin Pract. 2016 May;23:141-8. doi: 10.1016/j.ctcp.2015.04.002. Epub 2015 Apr 20.
citation: Erdogan M, Erdogan A, Erbil N, Karakaya HK, Demircan A. Prospective, Randomized, Placebo-controlled Study of the Effect of TENS on postthoracotomy pain and pulmonary function. World J Surg. 2005 Dec;29(12):1563-70. doi: 10.1007/s00268-005-7934-6.
citation: Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.
citation: Frödin, M., & Warrén Stomberg, M. (2014). Pain management after lung surgery. Nursing Reports, 4(1). https://doi.org/10.4081/nursrep.2014.3225
citation: Fu, J., & Yang, M. (2019). The Yellow Emperor's Classic of Medicine - Essential Questions: Translation of Huangdi Neijing Suwen. WORLD SCIENTIFIC. https://doi.org/10.1142/11080
citation: Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
citation: Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.
citation: Gupta A, Kaur K, Sharma S, Goyal S, Arora S, Murthy RS. Clinical aspects of acute post-operative pain management & its assessment. J Adv Pharm Technol Res. 2010 Apr;1(2):97-108.
citation: Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
citation: Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available.
citation: Hsiung DY, Liu CW, Cheng PC, Ma WF. Using non-invasive assessment methods to predict the risk of metabolic syndrome. Appl Nurs Res. 2015 May;28(2):72-7. doi: 10.1016/j.apnr.2014.12.001. Epub 2014 Dec 17.
citation: Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
citation: Kaplowitz J, Papadakos PJ. Acute pain management for video-assisted thoracoscopic surgery: an update. J Cardiothorac Vasc Anesth. 2012 Apr;26(2):312-21. doi: 10.1053/j.jvca.2011.04.010. Epub 2011 Jun 25. No abstract available.
citation: Kibler VA, Hayes RM, Johnson DE, Anderson LW, Just SL, Wells NL. Cultivating quality: early postoperative ambulation: back to basics. Am J Nurs. 2012 Apr;112(4):63-9. doi: 10.1097/01.NAJ.0000413460.45487.ea. No abstract available.
citation: 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.
citation: Kolcaba K, Schirm V, Steiner R. Effects of hand massage on comfort of nursing home residents. Geriatr Nurs. 2006 Mar-Apr;27(2):85-91. doi: 10.1016/j.gerinurse.2006.02.006.
citation: Kuroda H, Mizuno H, Dejima H, Watanabe K, Yoshida T, Naito Y, Sakao Y. A retrospective study on analgesic requirements for thoracoscopic surgery postoperative pain. J Pain Res. 2017 Nov 15;10:2643-2648. doi: 10.2147/JPR.S147691. eCollection 2017.
citation: Ma WF, Liu YC, Chen YF, Lane HY, Lai TJ, Huang LC. Evaluation of psychometric properties of the Chinese Mandarin version State-Trait Anxiety Inventory Y form in Taiwanese outpatients with anxiety disorders. J Psychiatr Ment Health Nurs. 2013 Aug;20(6):499-507. doi: 10.1111/j.1365-2850.2012.01945.x. Epub 2012 Jul 5.
citation: Mehta P, Dhapte V, Kadam S, Dhapte V. Contemporary acupressure therapy: Adroit cure for painless recovery of therapeutic ailments. J Tradit Complement Med. 2016 Jul 22;7(2):251-263. doi: 10.1016/j.jtcme.2016.06.004. eCollection 2017 Apr.
citation: Nomori H, Horio H, Naruke T, Suemasu K. What is the advantage of a thoracoscopic lobectomy over a limited thoracotomy procedure for lung cancer surgery? Ann Thorac Surg. 2001 Sep;72(3):879-84. doi: 10.1016/s0003-4975(01)02891-0.
citation: Pogatzki-Zahn EM, Segelcke D, Schug SA. Postoperative pain-from mechanisms to treatment. Pain Rep. 2017 Mar 15;2(2):e588. doi: 10.1097/PR9.0000000000000588. eCollection 2017 Mar.
citation: Sharifi Rizi M, Shamsalinia A, Ghaffari F, Keyhanian S, Naderi Nabi B. The effect of acupressure on pain, anxiety, and the physiological indexes of patients with cancer undergoing bone marrow biopsy. Complement Ther Clin Pract. 2017 Nov;29:136-141. doi: 10.1016/j.ctcp.2017.09.002. Epub 2017 Sep 5.
citation: Tamura M, Shimizu Y, Hashizume Y. Pain following thoracoscopic surgery: retrospective analysis between single-incision and three-port video-assisted thoracoscopic surgery. J Cardiothorac Surg. 2013 Jun 12;8:153. doi: 10.1186/1749-8090-8-153.
citation: Wang Y, Tang H, Guo Q, Liu J, Liu X, Luo J, Yang W. Effects of Intravenous Patient-Controlled Sufentanil Analgesia and Music Therapy on Pain and Hemodynamics After Surgery for Lung Cancer: A Randomized Parallel Study. J Altern Complement Med. 2015 Nov;21(11):667-72. doi: 10.1089/acm.2014.0310. Epub 2015 Sep 2.
citation: You WY, Yeh TP, Lee KC, Ma WF. A Preliminary Study of the Comfort in Patients with Leukemia Staying in a Positive Pressure Isolation Room. Int J Environ Res Public Health. 2020 May 22;17(10):3655. doi: 10.3390/ijerph17103655.
citation: Wu CL, Raja SN. Treatment of acute postoperative pain. Lancet. 2011 Jun 25;377(9784):2215-25. doi: 10.1016/S0140-6736(11)60245-6.
citation: World Health Organization. (1991). A Proposed Standard International Acupuncture Nomenclature: Report of a WHO Scientific Group. Annals of Internal Medicine, 115(4), 335. https://doi.org/10.7326/0003-4819-115-4-335_2
citation: Abouarab AA, Rahouma M, Kamel M, Ghaly G, Mohamed A. Single Versus Multi-Incisional Video-Assisted Thoracic Surgery: A Systematic Review and Meta-analysis. J Laparoendosc Adv Surg Tech A. 2018 Feb;28(2):174-185. doi: 10.1089/lap.2017.0446. Epub 2017 Nov 6.