The Power of Healing Statements on Post Operative Pain Control: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Baseline Pain (analyzed by VAS Numeric Pain Distress Scale)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
simple randomization
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Healing Statements
Patients in the healing statements group will be read healing statements during anesthesia induction, prior to undergoing surgery.
Intervention: Healing Statements (Other)
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.
Outcomes
Primary Outcomes
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: 2 weeks after surgery
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
Secondary Outcomes
- Time to First Bowel Movement(Followed for 2 weeks after surgery)
- Time to Pass Void Trial (Urination)(Followed for 2 weeks after surgery)
- Post operative Nausea and Vomiting (analyzed by Post-Operative Nausea and Vomiting Intensity Scale)(6 hours after surgery and 24 hours after surgery)
- Patient Perception of Improvement(2 weeks after surgery)