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Effects of Massage on Post-operative Pain in Urologic Patients

Primary Purpose

Postoperative Pain, Anxiety

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Massage Therapy
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loma Linda University Heart and Surgical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Massage Therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change from baseline in pain on the visual analogue scale score and survey
Change from baseline in anxiety on the State Trait Anxiety Inventory (STAI)

Secondary Outcome Measures

Change from baseline in patient satisfaction on the Patient Satisfaction Questionnaire 18 (PSQ18)
Length of hospital stay by chart review
Narcotic use (dosage, frequency, etc.) by chart review

Full Information

First Posted
July 10, 2014
Last Updated
February 5, 2015
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT02209233
Brief Title
Effects of Massage on Post-operative Pain in Urologic Patients
Official Title
Effects of Massage on Post-operative Pain in Urologic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Withdrawn
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
If randomized to the control group, patients will not be receiving massage therapy.
Arm Title
Massage Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Massage Therapy
Primary Outcome Measure Information:
Title
Change from baseline in pain on the visual analogue scale score and survey
Time Frame
Baseline, 0-1 hour after intervention
Title
Change from baseline in anxiety on the State Trait Anxiety Inventory (STAI)
Time Frame
Baseline, 0-1 hours after intervention
Secondary Outcome Measure Information:
Title
Change from baseline in patient satisfaction on the Patient Satisfaction Questionnaire 18 (PSQ18)
Time Frame
Baseline, 0-1 hours after intervention
Title
Length of hospital stay by chart review
Time Frame
From enrollment to time of discharge, an expected average of 7 days
Title
Narcotic use (dosage, frequency, etc.) by chart review
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. Duane Baldwin, M.D.
Organizational Affiliation
Loma Linda University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Heart and Surgical Hospital
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22588767
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(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
Results Reference
background
PubMed Identifier
11153975
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. doi: 10.1016/s0005-7967(00)00030-9.
Results Reference
background
PubMed Identifier
9272792
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. doi: 10.1016/s0304-3959(97)00005-5.
Results Reference
background
PubMed Identifier
11354213
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. doi: 10.1136/emj.18.3.205.
Results Reference
background
PubMed Identifier
24374753
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. No abstract available.
Results Reference
background
PubMed Identifier
19087756
Citation
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.
Results Reference
background
PubMed Identifier
24439644
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.
Results Reference
background
PubMed Identifier
11408136
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. doi: 10.1016/s0886-3350(00)00730-6.
Results Reference
background
PubMed Identifier
22964355
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.
Results Reference
background
PubMed Identifier
23833593
Citation
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.
Results Reference
background
PubMed Identifier
20347840
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.
Results Reference
background
PubMed Identifier
21167456
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.
Results Reference
background
PubMed Identifier
23972865
Citation
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.
Results Reference
background
PubMed Identifier
24882025
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.
Results Reference
background
PubMed Identifier
15297952
Citation
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.
Results Reference
background
PubMed Identifier
23883565
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. No abstract available.
Results Reference
background

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Effects of Massage on Post-operative Pain in Urologic Patients

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