Washington, District of Columbia 20010


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02502357


Primary Contact:

Principal Investigator
Cheryl Iglesia, MD
Medstar Washington Hospital Center

Joanna L Peterson, BSN, RN, CCRC
Phone: 202-877-6526
Email: joanna.l.peterson@medstar.net


Backup Contact:

Email: jlh263@georgetown.edu
Jessica L Howard, BA
Phone: 714-614-3358


Location Contact:

Washington, District of Columbia 20010
United States

Joanna L Peterson, BSN, RN, CCRC
Phone: 202-877-0526
Email: joanna.l.peterson@medstar.net

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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