Effects of Massage on Post-operative Pain in Urologic Patients

February 5, 2015 updated by: Loma Linda University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Heart and Surgical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
If randomized to the control group, patients will not be receiving massage therapy.
EXPERIMENTAL: 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.
Other: Massage Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in pain on the visual analogue scale score and survey
Time Frame: Baseline, 0-1 hour after intervention
Baseline, 0-1 hour after intervention
Change from baseline in anxiety on the State Trait Anxiety Inventory (STAI)
Time Frame: Baseline, 0-1 hours after intervention
Baseline, 0-1 hours after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in patient satisfaction on the Patient Satisfaction Questionnaire 18 (PSQ18)
Time Frame: Baseline, 0-1 hours after intervention
Baseline, 0-1 hours after intervention
Length of hospital stay by chart review
Time Frame: From enrollment to time of discharge, an expected average of 7 days
From enrollment to time of discharge, an expected average of 7 days
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
Participants will be followed for the duration of hospital stay, an expected average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: D. Duane Baldwin, M.D., Loma Linda University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (ESTIMATE)

August 5, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2015

Last Update Submitted That Met QC Criteria

February 5, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5140181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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