Randomized trial of acupressure to improve patient satisfaction and quality of recovery in hospitalized patients: study protocol for a randomized controlled trial

Eric Noll, Shivam Shodhan, Maria Cecilia Madariaga, Christopher R Page, Diane Santangelo, Xiaojun Guo, Ehab Al Bizri, Aurora D Pryor, Jamie Romeiser, Elliott Bennett-Guerrero, Eric Noll, Shivam Shodhan, Maria Cecilia Madariaga, Christopher R Page, Diane Santangelo, Xiaojun Guo, Ehab Al Bizri, Aurora D Pryor, Jamie Romeiser, Elliott Bennett-Guerrero

Abstract

Background: Acupressure therapy may be potentially beneficial in improving postoperative symptoms like postoperative nausea and vomiting (PONV), pain and sleep disorder and improving postoperative quality of recovery. The primary aim of this study is to investigate the efficacy of acupressure therapy on postoperative patient satisfaction and quality of recovery in hospitalized patients after surgical treatment.

Methods/design: This three-group, parallel, superiority, blinded, randomized controlled trial will test the hypothesis that a combination of PC6, LI4 and HT7 acupressure is superior to sham or no intervention for improving postoperative quality of recovery in hospitalized patients. A minimum of 150 patients will be randomly allocated to one of the three experimental groups: control (no visit), light touch (sham acupressure) or active acupressure therapy in a 1:1:1 ratio. Interventions will be performed three times a day for 2 days. Patient satisfaction, quality of recovery, PONV and pain will be measured during the 3 days following randomization. The study protocol was approved by the Stony Brook University Institutional Review Board on 21 March 2016. Written informed consent will be recorded from every consented patient.

Discussion: This study has the potential to improve the recovery of hospitalized patients by adding knowledge on the efficacy of acupressure therapy in this setting. A multipoint acupressure protocol will be compared to both a no intervention group and a light touch group, providing insight into different aspects of the placebo effect.

Trial registration: ClinicalTrial.gov, NCT02762435 . Registered on 14 April 2016.

Keywords: Acupressure therapy; Patient satisfaction; Quality of recovery.

Figures

Fig. 1
Fig. 1
The Consolidated Standards of Reporting Trials (CONSORT) flow diagram template for the AcuPressure to improve Patient satisfaction and quality of Recovery (APPROVE) study
Fig. 2
Fig. 2
APPROVE study schedule of enrolment, interventions and assessments
Fig. 3
Fig. 3
PC6, LI4 and HT7 acupoint locations. The acupoints are represented by the applied thumb position

References

    1. Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet Lond Engl. 2008;372:139–44. doi: 10.1016/S0140-6736(08)60878-8.
    1. Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MPW, Ahern A, Griggs K, Scott R, Hinds C, Rowan K, OPTIMISE Study Group Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014;311:2181–90. doi: 10.1001/jama.2014.5305.
    1. Futier E, Constantin J-M, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant J-Y, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin J-E, Pereira B, Jaber S, IMPROVE Study Group A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013;369:428–37. doi: 10.1056/NEJMoa1301082.
    1. Bowyer A, Jakobsson J, Ljungqvist O, Royse C. A review of the scope and measurement of postoperative quality of recovery. Anaesthesia. 2014;69:1266–78. doi: 10.1111/anae.12730.
    1. Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999;88:83–90.
    1. Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013;118:1332–40. doi: 10.1097/ALN.0b013e318289b84b.
    1. Liu X-L, Tan J-Y, Molassiotis A, Suen LKP, Shi Y. Acupuncture-point stimulation for postoperative pain control: a systematic review and meta-analysis of randomized controlled trials. Evid Based Complement Altern Med. 2015;2015:657809.
    1. Lee EJ, Frazier SK. The efficacy of acupressure for symptom management: a systematic review. J Pain Symptom Manage. 2011;42:589–603. doi: 10.1016/j.jpainsymman.2011.01.007.
    1. Lee A, Chan SKC, Fan LTY. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2015;11:CD003281.
    1. Hsieh LL-C, Kuo C-H, Lee LH, Yen AM-F, Chien K-L, Chen TH-H. Treatment of low back pain by acupressure and physical therapy: randomised controlled trial. BMJ. 2006;332:696–700. doi: 10.1136/.
    1. Chen J-H, Chao Y-H, Lu S-F, Shiung T-F, Chao Y-F. The effectiveness of valerian acupressure on the sleep of ICU patients: a randomized clinical trial. Int J Nurs Stud. 2012;49:913–20. doi: 10.1016/j.ijnurstu.2012.02.012.
    1. World Health Organization . WHO standard acupuncture point locations in the Western Pacific region. Manila: WHO Regional Office for the Western Pacific; 2008.
    1. Beikmoradi A, Najafi F, Roshanaei G, Pour Esmaeil Z, Khatibian M, Ahmadi A. Acupressure and anxiety in cancer patients. Iran Red Crescent Med J. 2015;17:e25919. doi: 10.5812/ircmj.25919.
    1. Tan J-Y, Suen LKP, Wang T, Molassiotis A. Sham acupressure controls used in randomized controlled trials: a systematic review and critique. PLoS One. 2015;10:e0132989. doi: 10.1371/journal.pone.0132989.
    1. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WSM, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D. STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. J Evid-Based Med. 2010;3:140–55. doi: 10.1111/j.1756-5391.2010.01086.x.
    1. Chazapis M, Walker EMK, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016;116:241–8. doi: 10.1093/bja/aev413.
    1. Alon M. Musculoskeletal disorders healing methods from Chinese medicine, orthopaedic medicine and osteopathy. Berkeley: North Atlantic Books; 1999.
    1. Herman NL, Carter B, Van Decar TK. Cricoid pressure: teaching the recommended level. Anesth Analg. 1996;83:859–63. doi: 10.1213/00000539-199610000-00036.
    1. Sterne JAC, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009;338:b2393. doi: 10.1136/bmj.b2393.
    1. Vincent JL, Moreno R, Takala J, Willatts S, De Mendonça A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996;22:707–10. doi: 10.1007/BF01709751.
    1. Tsay S-L, Wang J-C, Lin K-C, Chung U-L. Effects of acupressure therapy for patients having prolonged mechanical ventilation support. J Adv Nurs. 2005;52:142–50. doi: 10.1111/j.1365-2648.2005.03576.x.
    1. Ming J-L, Kuo BI-T, Lin J-G, Lin L-C. The efficacy of acupressure to prevent nausea and vomiting in post-operative patients. J Adv Nurs. 2002;39:343–51. doi: 10.1046/j.1365-2648.2002.02295.x.
    1. Chung U-L, Hung L-C, Kuo S-C, Huang C-L. Effects of LI4 and BL 67 acupressure on labor pain and uterine contractions in the first stage of labor. J Nurs Res JNR. 2003;11:251–60. doi: 10.1097/01.JNR.0000347644.35251.c1.
    1. Lang T, Hager H, Funovits V, Barker R, Steinlechner B, Hoerauf K, Kober A. Prehospital analgesia with acupressure at the Baihui and Hegu points in patients with radial fractures: a prospective, randomized, double-blind trial. Am J Emerg Med. 2007;25:887–93. doi: 10.1016/j.ajem.2007.01.016.
    1. Kober A, Scheck T, Greher M, Lieba F, Fleischhackl R, Fleischhackl S, Randunsky F, Hoerauf K. Prehospital analgesia with acupressure in victims of minor trauma: a prospective, randomized, double-blinded trial. Anesth Analg. 2002;95:723–7.
    1. Wang S, Chen Z, Fu P, Zang L, Wang L, Zhai X, Gao F, Huang A, Zhang Y. Use of auricular acupressure to improve the quality of life in diabetic patients with chronic kidney diseases: a prospective randomized controlled trial. Evid-Based Complement Altern Med. 2014;2014:343608.
    1. Pouresmail Z, Ibrahimzadeh R. Effects of acupressure and ibuprofen on the severity of primary dysmenorrhea. J Tradit Chin Med. 2002;22:205–10.
    1. Yang M-H, Lin L-C, Wu S-C, Chiu J-H, Wang P-N, Lin J-G. Comparison of the efficacy of aroma-acupressure and aromatherapy for the treatment of dementia-associated agitation. BMC Complement Altern Med. 2015;15.
    1. Chang L-H, Hsu C-H, Jong G-P, Ho S, Tsay S-L, Lin K-C. Auricular acupressure for managing postoperative pain and knee motion in patients with total knee replacement: a randomized sham control study. Evid Based Complement Altern Med. 2012;2012:528452.
    1. Shin HS, Song YA, Seo S. Effect of Nei-Guan point (P6) acupressure on ketonuria levels, nausea and vomiting in women with hyperemesis gravidarum. J Adv Nurs. 2007;59:510–9. doi: 10.1111/j.1365-2648.2007.04342.x.
    1. Myles PS, Myles DB, Galagher W, Chew C, MacDonald N, Dennis A. Minimal clinically important difference for three quality of recovery scales. Anesthesiology. 2016;125:39–45. doi: 10.1097/ALN.0000000000001158.

Source: PubMed

3
Subscribe