Healing Statements and Their Effect on Post Operative Pain



Status:Recruiting
Conditions:Post-Surgical Pain, Women's Studies
Therapuetic Areas:Musculoskeletal, Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2015
End Date:September 2016
Contact:Joanna L Peterson, BSN, RN, CCRC
Email:joanna.l.peterson@medstar.net
Phone:202-877-6526

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The Power of Healing Statements on Post Operative Pain Control: A Randomized Controlled Trial

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.

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.

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
We found this trial at
1
site
110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Principal Investigator: Cheryl Iglesia, MD
Phone: 202-877-0526
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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from
Washington,
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