Clinical trial NCT02502357: Healing Statements and Their Effect on Post Operative Pain
Official title: The Power of Healing Statements on Post Operative Pain Control: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pain control
healing statements
pelvic prolapse
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Baseline Pain (analyzed by VAS Numeric Pain Distress Scale)
timeFrame: baseline
measure: Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
timeFrame: 6 hours after surgery
measure: Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
timeFrame: 24 hours after surgery
measure: Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
timeFrame: 2 weeks after surgery
Secondary outcomes:
measure: Post operative Nausea and Vomiting (analyzed by Post-Operative Nausea and Vomiting Intensity Scale)
timeFrame: 6 hours after surgery and 24 hours after surgery
measure: Time to First Bowel Movement
timeFrame: Followed for 2 weeks after surgery
measure: Time to Pass Void Trial (Urination)
timeFrame: Followed for 2 weeks after surgery
measure: Patient Perception of Improvement
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Cheryl Iglesia, MD
role: PRINCIPAL_INVESTIGATOR
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