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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

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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Other: Healing Statements Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Power of Healing Statements on Post Operative Pain Control: A Randomized Controlled Trial
Study Start Date : July 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Healing Statements
Patients in the healing statements group will be read healing statements during anesthesia induction, prior to undergoing surgery.
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."


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.



Primary Outcome Measures :
  1. Baseline Pain (analyzed by VAS Numeric Pain Distress Scale) [ Time Frame: baseline ]
    Pain

  2. Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale) [ Time Frame: 6 hours after surgery ]
    Pain

  3. Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale) [ Time Frame: 24 hours after surgery ]
    Pain

  4. Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale) [ Time Frame: 2 weeks after surgery ]
    Pain


Secondary Outcome Measures :
  1. 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

  2. Time to First Bowel Movement [ Time Frame: Followed for 2 weeks after surgery ]
    Bowel Movement

  3. Time to Pass Void Trial (Urination) [ Time Frame: Followed for 2 weeks after surgery ]
    Urination

  4. Patient Perception of Improvement [ Time Frame: 2 weeks after surgery ]
    Patient Perception of Improvement measured by Patient Global Perception of Improvement Scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502357


Contacts
Contact: Joanna L Peterson, BSN, RN, CCRC 202-877-6526 joanna.l.peterson@medstar.net
Contact: Jessica L Howard, BA 714-614-3358 jlh263@georgetown.edu

Locations
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Joanna L Peterson, BSN, RN, CCRC    202-877-0526    joanna.l.peterson@medstar.net   
Contact: Jessica L Howard, BA    714-614-3358    jlh263@georgetown.edu   
Principal Investigator: Cheryl Iglesia, MD         
Sponsors and Collaborators
Medstar Health Research Institute
Investigators
Principal Investigator: Cheryl Iglesia, MD Medstar Washington Hospital Center

Publications of Results:
Huddleston P. Prepare for Surgery, Heal Faster: A Guide of Mindy-Body Techniques. Angel River Press, 2012.
Watters M, Feldman J, Schoetz D, Abrams M, Goy C, Catman M, Huddleston P. The Power of Relaxation: A Holistic Approach to Preoperative Patient Education.
Huddleston M, Bierbaum B. Cost-effectiveness of Using Mind-Body Techniques for Total Knee-Joint Replacement.
Hutchings DD. The value of suggestion given under anesthesia: A report and evaluation of 200 cases. American Journal of Clinical Hypnosis 1961; 26-29.
Furlong M. Positive suggestions presented during anaesthesia. Memory and Awareness in Anaesthesia (Amsterdam: Swets & Zeitlinger, 1990).
Wolfe LS, Millet JB. Control of postoperative pain by suggestion under general anesthesia. American Journal of Clinical Hypnosis 1960; 3:109-112.
Steinberg ME, Hord AH, Reed B, Sebels PS. Study of the effect of intraoperative analgesia and well-being. Memory and Awareness in Anesthesia (Englewood Cliffs, NJ: Prenctice Hall, 1993).

Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT02502357     History of Changes
Other Study ID Numbers: 2015-043
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Medstar Health Research Institute:
pain control
healing statements
pelvic prolapse

Additional relevant MeSH terms:
Prolapse
Pain, Postoperative
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms