Effects of Massage on Post-operative Pain in Urologic Patients

NCT02209233 | Withdrawn DMC

• 1 other identifier: 5140181
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Anxiety

Outcome Measures

Primary Outcomes (2)

• Change from baseline in pain on the visual analogue scale score and survey

  Baseline, 0-1 hour after intervention

• Change from baseline in anxiety on the State Trait Anxiety Inventory (STAI)

  Baseline, 0-1 hours after intervention

Secondary Outcomes (3)

• Change from baseline in patient satisfaction on the Patient Satisfaction Questionnaire 18 (PSQ18)

  Baseline, 0-1 hours after intervention

• Length of hospital stay by chart review

  From enrollment to time of discharge, an expected average of 7 days

• Narcotic use (dosage, frequency, etc.) by chart review

  Participants will be followed for the duration of hospital stay, an expected average of 1 week

Study Arms (2)

Control

NO INTERVENTION

If randomized to the control group, patients will not be receiving massage therapy.

Massage Therapy

EXPERIMENTAL

If randomized to the intervention group, patients will receive massage therapy of the hand, arm, shoulder, and neck by the licensed massage therapist on duty. The massage will be given in a manner that is congruent with standard of care practices by the Heart and Surgical Hospital and the licensed massage therapist.

Other: Massage Therapy

Interventions

Massage Therapy OTHER

Massage Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Given pain medication in the past hour

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Heart and Surgical Hospital

Loma Linda, California, 92354, United States

Location

Related Publications (16)

• 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(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.

  PMID: 22588767 BACKGROUND

• 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. doi: 10.1016/s0005-7967(00)00030-9.

  PMID: 11153975 BACKGROUND

• 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. doi: 10.1016/s0304-3959(97)00005-5.

  PMID: 9272792 BACKGROUND

• 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. doi: 10.1136/emj.18.3.205.

  PMID: 11354213 BACKGROUND

• 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. No abstract available.

  PMID: 24374753 BACKGROUND

• Campeau MP, Gaboriault R, Drapeau M, Van Nguyen T, Roy I, Fortin B, Marois M, Nguyen-Tan 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. doi: 10.2310/7200.2007.018.

  PMID: 19087756 BACKGROUND

• 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.

  PMID: 24439644 BACKGROUND

• 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. doi: 10.1016/s0886-3350(00)00730-6.

  PMID: 11408136 BACKGROUND

• 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.

  PMID: 22964355 BACKGROUND

• 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.

  PMID: 23833593 BACKGROUND

• 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.

  PMID: 20347840 BACKGROUND

• 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.

  PMID: 21167456 BACKGROUND

• Buyukyilmaz 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.

  PMID: 23972865 BACKGROUND

• 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.

  PMID: 24882025 BACKGROUND

• Wang HL, Keck JF. Foot and hand massage as an intervention for postoperative pain. Pain Manag Nurs. 2004 Jun;5(2):59-65. doi: 10.1016/j.pmn.2004.01.002.

  PMID: 15297952 BACKGROUND

• 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. No abstract available.

  PMID: 23883565 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders

Interventions

Massage

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• D. Duane Baldwin, M.D.

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: August 5, 2014
• Study Start: February 1, 2015
• Primary Completion: February 1, 2015
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

US (1)