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Healing Statements and Their Effect on Post Operative Pain (PHSPOPC)

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ClinicalTrials.gov Identifier: NCT02502357
Recruitment Status : Unknown
Verified March 2016 by Medstar Health Research Institute.
Recruitment status was:  Recruiting
First Posted : July 20, 2015
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Medstar Health Research Institute

Tracking Information
First Submitted Date  ICMJE June 16, 2015
First Posted Date  ICMJE July 20, 2015
Last Update Posted Date March 16, 2016
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
  • Baseline Pain (analyzed by VAS Numeric Pain Distress Scale) [ Time Frame: baseline ]
    Pain
  • Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale) [ Time Frame: 6 hours after surgery ]
    Pain
  • Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale) [ Time Frame: 24 hours after surgery ]
    Pain
  • Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale) [ Time Frame: 2 weeks after surgery ]
    Pain
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
  • Post operative Nausea and Vomiting (analyzed by Post-Operative Nausea and Vomiting Intensity Scale) [ Time Frame: 6 hours after surgery and 24 hours after surgery ]
    Nausea and Vomiting
  • Time to First Bowel Movement [ Time Frame: Followed for 2 weeks after surgery ]
    Bowel Movement
  • Time to Pass Void Trial (Urination) [ Time Frame: Followed for 2 weeks after surgery ]
    Urination
  • Patient Perception of Improvement [ Time Frame: 2 weeks after surgery ]
    Patient Perception of Improvement measured by Patient Global Perception of Improvement Scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healing Statements and Their Effect on Post Operative Pain
Official Title  ICMJE The Power of Healing Statements on Post Operative Pain Control: A Randomized Controlled Trial
Brief Summary This is a randomized clinical trial comparing the severity of post-operative pain and use of pain medication in women who are and are not exposed to healing statements before undergoing vaginal hysterectomy with minimally invasive sacrocolpopexy. The investigators' hypothesis is that those who are read healing statements before surgery will require less post-operative pain medications and experience less severe pain than those who do not hear the statements.
Detailed Description

This is a randomized controlled trial of women undergoing vaginal hysterectomy with minimally invasive sacrocolpopexy. Eligible patients will be approached for study participation after they have decided to proceed with the vaginal hysterectomy with minimally invasive sacrocolpopexy. After enrollment, demographics including age, race, prolapse stage, and medical history will be collected. Before vaginal hysterectomy with minimally invasive sacrocolpopexy in the OR, they will be randomized to the group that will be read healing statements or to the group without healing statements. Women randomized to the healing statement group will have the following statements read to them by a trained research staff member, using Peggy Huddleston's technique. Before the patient is placed under general anesthesia, the study staff member will repeat 5 times:

"Following this operation, [the participant] will feel very comfortable and [the participant] will heal very well"

Toward the end of the surgery, the study staff member will say 5 times:

"The operation has gone very well." "Following the operation, [the participant] will be hungry. [The participant] will be thirsty and urinate easily."

Prior to reading these statements to the patient, the research staff member will listen to a previously recorded audio sample of how the statements should be read with regard to tone of voice and attitude.

Patients will then fill out the VAS pain scale 6 and 24 hours after surgery. Pain medication use, dosage, type of medication will be assessed by examining electronic medical records. Time to pass void trial and time to first bowel movement will be recorded on paper and brought to the patient's 2-week follow up visit. Nausea will be assessed 6 and 24 hours after surgery using the Postoperative Nausea and Vomiting (PONV) Intensity Scale. Patients will be given standard post-operative instructions for a vaginal hysterectomy with minimally invasive sacrocolpopexy, and be told to come to the clinic in 2 weeks for a follow up visit. During this time, the will be told to keep a daily diary of pain medication use including name, dosage, and amount taken. At the 2-week visit, the patient will fill out another VAS pain scale and PFDI-20 and their pain medication diaries will be collected. The patient's overall sense of recovery will be assessed using the PGI. Once the data is collected, statistical analysis will be performed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pelvic Organ Prolapse
Intervention  ICMJE Other: Healing Statements

Before the patient in the experimental group is placed under general anesthesia, the study staff member will repeat 5 times:

"Following this operation, [the participant] will feel very comfortable and [the participant] will heal very well."

Toward the end of the surgery, the study staff member will say 5 times:

"The operation has gone very well." "Following the operation, [the participant] will be hungry. [The participant] will be thirsty and urinate easily."

Study Arms  ICMJE
  • Experimental: Healing Statements
    Patients in the healing statements group will be read healing statements during anesthesia induction, prior to undergoing surgery.
    Intervention: Other: Healing Statements
  • No Intervention: No Healing Statements
    Patients in the no healing statements group will not be read healing statements during anesthesia induction prior to undergoing surgery. They will receive standard of care.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 17, 2015)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women who undergo vaginal hysterectomy with minimally invasive sacrocolpopexy
  • Age ≥18 years
  • English speaking
  • Available for 2 week follow up
  • Able to complete study questionnaires

Exclusion Criteria:

  • History of chronic pain prior to surgery
  • Pain during intercourse or in lower abdomen or genital region at baseline prior to index surgery (identified if patient answers yes to question 20 on the Pelvic Floor Distress Inventory-20)
  • Hearing impairment
  • Pregnancy by self-report or positive pregnancy test
  • Active pelvic infection, herpes, candidiasis
  • Indication for surgery is due to neoplasm
  • History of pain syndromes including fibromyalgia, interstitial cystitis, dysmenorrhea, and depression
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02502357
Other Study ID Numbers  ICMJE 2015-043
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medstar Health Research Institute
Study Sponsor  ICMJE Medstar Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cheryl Iglesia, MD Medstar Washington Hospital Center
PRS Account Medstar Health Research Institute
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP