PHSPOPC: Healing Statements and Their Effect on Post Operative Pain

Sponsor

Medstar Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02502357

Collaborator

(none)

Enrollment

Location

Arms

14.5

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

simple randomization

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Mar 8, 2016

Actual Study Completion Date :

Sep 14, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Baseline Pain (analyzed by VAS Numeric Pain Distress Scale) [baseline]
Pain
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale) [6 hours after surgery]
Pain
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale) [24 hours after surgery]
Pain
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale) [2 weeks after surgery]
Pain

Secondary Outcome Measures

Post operative Nausea and Vomiting (analyzed by Post-Operative Nausea and Vomiting Intensity Scale) [6 hours after surgery and 24 hours after surgery]
Nausea and Vomiting
Time to First Bowel Movement [Followed for 2 weeks after surgery]
Bowel Movement
Time to Pass Void Trial (Urination) [Followed for 2 weeks after surgery]
Urination
Patient Perception of Improvement [2 weeks after surgery]
Patient Perception of Improvement measured by Patient Global Perception of Improvement Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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