Effects of Massage on Post-operative Pain in Urologic Patients

Anxiety Clinical Trial

Official title:

Effects of Massage on Post-operative Pain in Urologic Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02209233
• Other study ID #: 5140181
• Status: Withdrawn
• Phase: N/A
• First received: July 10, 2014
• Last updated: February 5, 2015
• Start date: February 2015

Study information

• Verified date: February 2015
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect that receiving massage therapy post-operatively has on reducing perceived anxiety and pain in urology patients. Secondarily, the result of massage on patient satisfaction, length of hospital stay, and narcotic use will also be studied.

Description:

Post-operative pain for Urology patients can be an anxiety-provoking and distressing recovery process. Massage therapy for post-operative pain has been shown to reduce pain and anxiety levels in various surgical patients however no study has assessed massage therapy effect on post-operative pain in patients who have gone through urological procedures.

This study will investigate the effects of hand massage interventions during the post-operative period of Urology patients. Perception of pain and anxiety levels will be assessed, as well as vital signs before and after massage therapy will be measured. These findings may lead to both subjective and objective improvements in patients undergoing urological surgeries and procedures.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Urology patients over the age of 18 years old who are post-operative day 1 to post-operative day 4.

Exclusion Criteria:

• Given pain medication in the past hour

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Massage Therapy

Locations

Country	Name	City	State
United States	Loma Linda University Heart and Surgical Hospital	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (16)

Babaee S, Shafiei Z, Sadeghi MM, Nik AY, Valiani M. Effectiveness of massage therapy on the mood of patients after open-heart surgery. Iran J Nurs Midwifery Res. 2012 Feb;17(2 Suppl 1):S120-4. — View Citation

Bagheri-Nesami M, Shorofi SA, Zargar N, Sohrabi M, Gholipour-Baradari A, Khalilian A. The effects of foot reflexology massage on anxiety in patients following coronary artery bypass graft surgery: a randomized controlled trial. Complement Ther Clin Pract. 2014 Feb;20(1):42-7. doi: 10.1016/j.ctcp.2013.10.006. Epub 2013 Oct 25. — View Citation

Braun LA, Stanguts C, Casanelia L, Spitzer O, Paul E, Vardaxis NJ, Rosenfeldt F. Massage therapy for cardiac surgery patients--a randomized trial. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1453-9, 1459.e1. doi: 10.1016/j.jtcvs.2012.04.027. Epub 2012 Sep 7. — View Citation

Büyükyilmaz F, Asti T. The effect of relaxation techniques and back massage on pain and anxiety in Turkish total hip or knee arthroplasty patients. Pain Manag Nurs. 2013 Sep;14(3):143-54. doi: 10.1016/j.pmn.2010.11.001. Epub 2011 Jan 28. — View Citation

Campeau MP, Gaboriault R, Drapeau M, Van Nguyen T, Roy I, Fortin B, Marois M, Nguyen-Tân PF. Impact of massage therapy on anxiety levels in patients undergoing radiation therapy: randomized controlled trial. J Soc Integr Oncol. 2007 Fall;5(4):133-8. — View Citation

Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate pain in millimetres? Pain. 1997 Aug;72(1-2):95-7. — View Citation

Cutshall SM, Wentworth LJ, Engen D, Sundt TM, Kelly RF, Bauer BA. Effect of massage therapy on pain, anxiety, and tension in cardiac surgical patients: a pilot study. Complement Ther Clin Pract. 2010 May;16(2):92-5. doi: 10.1016/j.ctcp.2009.10.006. Epub 2009 Nov 14. — View Citation

Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S467-72. doi: 10.1002/acr.20561. Review. — View Citation

Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. — View Citation

Kim MS, Cho KS, Woo H, Kim JH. Effects of hand massage on anxiety in cataract surgery using local anesthesia. J Cataract Refract Surg. 2001 Jun;27(6):884-90. — View Citation

Reed MD, Van Nostran W. Assessing pain intensity with the visual analog scale: a plea for uniformity. J Clin Pharmacol. 2014 Mar;54(3):241-4. doi: 10.1002/jcph.250. Epub 2014 Jan 23. — View Citation

Stanley MA, Novy DM, Bourland SL, Beck JG, Averill PM. Assessing older adults with generalized anxiety: a replication and extension. Behav Res Ther. 2001 Feb;39(2):221-35. — View Citation

Thayaparan AJ, Mahdi E. The Patient Satisfaction Questionnaire Short Form (PSQ-18) as an adaptable, reliable, and validated tool for use in various settings. Med Educ Online. 2013 Jul 23;18:21747. doi: 10.3402/meo.v18i0.21747. — View Citation

Ucuzal M, Kanan N. Foot massage: effectiveness on postoperative pain in breast surgery patients. Pain Manag Nurs. 2014 Jun;15(2):458-65. doi: 10.1016/j.pmn.2012.03.001. Epub 2012 Jun 20. — View Citation

Wang AT, Sundt TM 3rd, Cutshall SM, Bauer BA. Massage therapy after cardiac surgery. Semin Thorac Cardiovasc Surg. 2010 Autumn;22(3):225-9. doi: 10.1053/j.semtcvs.2010.10.005. Review. — View Citation

Wang HL, Keck JF. Foot and hand massage as an intervention for postoperative pain. Pain Manag Nurs. 2004 Jun;5(2):59-65. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain on the visual analogue scale score and survey		Baseline, 0-1 hour after intervention	No
Primary	Change from baseline in anxiety on the State Trait Anxiety Inventory (STAI)		Baseline, 0-1 hours after intervention	No
Secondary	Change from baseline in patient satisfaction on the Patient Satisfaction Questionnaire 18 (PSQ18)		Baseline, 0-1 hours after intervention	No
Secondary	Length of hospital stay by chart review		From enrollment to time of discharge, an expected average of 7 days	No
Secondary	Narcotic use (dosage, frequency, etc.) by chart review		Participants will be followed for the duration of hospital stay, an expected average of 1 week	No