<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02209233</url>
  </required_header>
  <id_info>
    <org_study_id>5140181</org_study_id>
    <nct_id>NCT02209233</nct_id>
  </id_info>
  <brief_title>Effects of Massage on Post-operative Pain in Urologic Patients</brief_title>
  <official_title>Effects of Massage on Post-operative Pain in Urologic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect that receiving massage therapy&#xD;
      post-operatively has on reducing perceived anxiety and pain in urology patients. Secondarily,&#xD;
      the result of massage on patient satisfaction, length of hospital stay, and narcotic use will&#xD;
      also be studied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-operative pain for Urology patients can be an anxiety-provoking and distressing recovery&#xD;
      process. Massage therapy for post-operative pain has been shown to reduce pain and anxiety&#xD;
      levels in various surgical patients however no study has assessed massage therapy effect on&#xD;
      post-operative pain in patients who have gone through urological procedures.&#xD;
&#xD;
      This study will investigate the effects of hand massage interventions during the&#xD;
      post-operative period of Urology patients. Perception of pain and anxiety levels will be&#xD;
      assessed, as well as vital signs before and after massage therapy will be measured. These&#xD;
      findings may lead to both subjective and objective improvements in patients undergoing&#xD;
      urological surgeries and procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>February 2015</start_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in pain on the visual analogue scale score and survey</measure>
    <time_frame>Baseline, 0-1 hour after intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in anxiety on the State Trait Anxiety Inventory (STAI)</measure>
    <time_frame>Baseline, 0-1 hours after intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in patient satisfaction on the Patient Satisfaction Questionnaire 18 (PSQ18)</measure>
    <time_frame>Baseline, 0-1 hours after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay by chart review</measure>
    <time_frame>From enrollment to time of discharge, an expected average of 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Narcotic use (dosage, frequency, etc.) by chart review</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 week</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>If randomized to the control group, patients will not be receiving massage therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Massage Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Massage Therapy</intervention_name>
    <arm_group_label>Massage Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Urology patients over the age of 18 years old who are post-operative day 1 to&#xD;
             post-operative day 4.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Given pain medication in the past hour&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>D. Duane Baldwin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University Heart and Surgical Hospital</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>22588767</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11153975</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>9272792</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11354213</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24374753</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19087756</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24439644</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11408136</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22964355</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23833593</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20347840</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21167456</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23972865</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24882025</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>15297952</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23883565</PMID>
  </reference>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>February 5, 2015</last_update_submitted>
  <last_update_submitted_qc>February 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02209233
org study id: 5140181
nct id: NCT02209233
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from baseline in pain on the visual analogue scale score and survey
time frame: Baseline, 0-1 hour after intervention
measure: Change from baseline in anxiety on the State Trait Anxiety Inventory (STAI)
time frame: Baseline, 0-1 hours after intervention
measure: Change from baseline in patient satisfaction on the Patient Satisfaction Questionnaire 18 (PSQ18)
time frame: Baseline, 0-1 hours after intervention
measure: Length of hospital stay by chart review
time frame: From enrollment to time of discharge, an expected average of 7 days
measure: 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
arm group label: Control
arm group type: No Intervention
description: If randomized to the control group, patients will not be receiving massage therapy.
arm group label: Massage Therapy
arm group type: Experimental
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: Massage Therapy
arm group label: Massage Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: D. Duane Baldwin, M.D.
role: Principal Investigator
affiliation: Loma Linda University Medical Center
facility: 
country: United States
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.
PMID: 22588767
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.
PMID: 11153975
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.
PMID: 9272792
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.
PMID: 11354213
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.
PMID: 24374753
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.
PMID: 19087756
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.
PMID: 24439644
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.
PMID: 11408136
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.
PMID: 22964355
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.
PMID: 23833593
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.
PMID: 20347840
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.
PMID: 21167456
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.
PMID: 23972865
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.
PMID: 24882025
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.
PMID: 15297952
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.
PMID: 23883565
responsible party type: Sponsor
mesh term: Pain, Postoperative