Postoperative PainNCT02209233
Effects of Massage on Post-operative Pain in Urologic Patients
A study testing Massage Therapy in people with Postoperative Pain and Anxiety, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Anxiety
- What is being tested?
- Massage Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urology patients over the age of 18 years old who are post-operative day 1 to post-operative day 4.
Who cannot join
- Given pain medication in the past hour
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Heart and Surgical Hospital
Loma Linda, California, 92354
About this study
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.
Read the 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.
- Conditions
- Postoperative Pain, Anxiety
- Being tested
- Massage Therapy
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Massage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain on the visual analogue scale score and survey
Measured: Baseline, 0-1 hour after intervention
Change from baseline in anxiety on the State Trait Anxiety Inventory (STAI)
Measured: Baseline, 0-1 hours after intervention
Secondary outcomes (3)
Change from baseline in patient satisfaction on the Patient Satisfaction Questionnaire 18 (PSQ18)
Measured: Baseline, 0-1 hours after intervention
Length of hospital stay by chart review
Measured: From enrollment to time of discharge, an expected average of 7 days
Narcotic use (dosage, frequency, etc.) by chart review
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startFeb 2015
- Primary completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D. Duane Baldwin, M.D., Principal investigator, Loma Linda University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209233
- Sponsor's protocol ID
- 5140181
- Status last verified
- Feb 2015
- First submitted
- 10 Jul 2014
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22588767Stanley 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.
PubMed 11153975Collins 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.
PubMed 9272792Kelly 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.
PubMed 11354213Reed 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.
PubMed 24374753Campeau 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.
PubMed 19087756Bagheri-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.
PubMed 24439644Kim 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.
PubMed 11408136Braun 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.
PubMed 22964355Babaee 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.
PubMed 23833593Cutshall 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.
PubMed 20347840Wang 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.
PubMed 21167456Buyukyilmaz 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.
PubMed 23972865Ucuzal 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.
PubMed 24882025Wang 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.
PubMed 15297952
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Massage on Post-operative Pain in Urologic Patients
- ClinicalTrials.gov ID
- NCT02209233
- Acronym / sponsor ID
- 5140181
- Conditions
- Postoperative Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2015 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –If randomized to the control group, patients will not be receiving massage therapy. |
| Massage Therapy | Experimental | Other: Massage TherapyIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Urology patients over the age of 18 years old who are post-operative day 1 to post-operative day 4.
Key exclusion criteria (1 listed)
- Given pain medication in the past hour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage Therapy | Other | Massage Therapy |
Primary outcome
Change from baseline in pain on the visual analogue scale score and survey
Time frame: 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
3 secondary outcomes
Change from baseline in patient satisfaction on the Patient Satisfaction Questionnaire 18 (PSQ18)
Time frame: 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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
- Background: PubMed 22588767Julian 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.
- Background: PubMed 11153975Stanley 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.
- Background: PubMed 9272792Collins 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.
- Background: PubMed 11354213Kelly 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.
- Background: PubMed 24374753Reed 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.
- Background: PubMed 19087756Campeau 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.
- Background: PubMed 24439644Bagheri-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.
- Background: PubMed 11408136Kim 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.
- Background: PubMed 22964355Braun 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.
- Background: PubMed 23833593Babaee 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.
- Background: PubMed 20347840Cutshall 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.
- Background: PubMed 21167456Wang 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.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D. Duane Baldwin, M.D. principal investigator
Loma Linda University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage Therapy in people with Postoperative Pain and Anxiety, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain on the visual analogue scale score and survey (time frame: Baseline, 0-1 hour after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02209233, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.