The Effectiveness of Acupressure for Managing Postoperative Pain and Anxiety in Patients With Thoracoscopic Surgery

Lung Diseases Clinical Trial

Official title:

Professor, School of Nursing, China Medical University Hospital, Principal Investigator

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04595253
• Other study ID #: CMUH109-REC2-131
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2020
• Est. completion date: September 2021

Study information

• Verified date: July 2021
• Source: China Medical University Hospital
• Contact: Wei-Fen Ma, Ph.D
• Phone: 04-22053366 Ext. 7107
• Email: lhdaisy[@]mail.cmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Other:
• acupressure
The acupressure involves the " Vaccaria Semen" within skin-colored adhesive tape that placed on the "Neiguan" and "Shenmen" acupoints as an intervention measure. Continue to massage the acupoints with fingertips for 10 minutes, 3 times per day (8 and 12 in the morning, and 4 in the afternoon) . The adhesive tape will be retained in situ for 2 days.

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
Wei-Fen Ma	China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (42)

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 — View 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

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):534-40, table of contents. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Endler NS, Kocovski NL. State and trait anxiety revisited. J Anxiety Disord. 2001 May-Jun;15(3):231-45. Review. — View 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. — View 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. — View 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. Review. — View Citation

Frödin, M., & Warrén Stomberg, M. (2014). Pain management after lung surgery. Nursing Reports, 4(1). https://doi.org/10.4081/nursrep.2014.3225

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

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. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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

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. Review. — View 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). pii: E3655. doi: 10.3390/ijerph17103655. — View Citation

* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analgesia Consumption	Injection time of morphine and ketorolac would be recorded.	during the whole admission, an average of 4 day.
Other	Comfort	as assessed by Shortened General Comfort Questionnaire	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
Other	Heart rate variability	as assessed by Nexus-10, wireless Biofeedback/Neurofeedback system	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.
Other	Early ambulation	The first ambulation time: act to walk with or without any kind of assistant after operation.	The first ambulation time after operation would be recorded, assessed up to 7 days.
Primary	Pain:Changes from baseline pain scale at post-operative day 2, after intervention.	as assessed by Visual Analogue Scale-Pain (VAS-P). The VAS-P scale is comprised of a horizontal line 100mm long with the indication "no pain" to the left and "worst possible pain" to the right. possible scores varied between 0-100. A higher scores mean a worse outcome.	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	Anxiety	as assessed by Visual Analogue Scale-Anxiety(VAS-A). The VAS-A scale is comprised of a horizontal line 100mm long with the indication "no anxiety" to the left and "worst possible anxiety" to the right. possible scores varied between 0-100. A higher scores mean a worse outcome.	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.
Secondary	Anxiety	as assessed by State-Trait Anxiety Inventory (STAI) Y form (STAI-Y1). It is 20 questions, which were rated from 1-4. Possible scores varied between 20-80. A STAI-Y1 score>40 as evidence of a state of anxiety.	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.

External Links

•   American Society of Anesthesiologists Physical Status Classification System.