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Healing Statements and Their Effect on Post Operative Pain (PHSPOPC)

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healing Statements
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pelvic Organ Prolapse focused on measuring pain control, healing statements, pelvic prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Washington Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Healing Statements

No Healing Statements

Arm Description

Patients in the healing statements group will be read healing statements during anesthesia induction, prior to undergoing surgery.

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 Outcome Measures

Baseline Pain (analyzed by VAS Numeric Pain Distress Scale)
Pain
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
Pain
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
Pain
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
Pain

Secondary Outcome Measures

Post operative Nausea and Vomiting (analyzed by Post-Operative Nausea and Vomiting Intensity Scale)
Nausea and Vomiting
Time to First Bowel Movement
Bowel Movement
Time to Pass Void Trial (Urination)
Urination
Patient Perception of Improvement
Patient Perception of Improvement measured by Patient Global Perception of Improvement Scale

Full Information

First Posted
June 16, 2015
Last Updated
August 19, 2020
Sponsor
Medstar Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02502357
Brief Title
Healing Statements and Their Effect on Post Operative Pain
Acronym
PHSPOPC
Official Title
The Power of Healing Statements on Post Operative Pain Control: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
March 8, 2016 (Actual)
Study Completion Date
September 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
pain control, healing statements, pelvic prolapse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
simple randomization
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healing Statements
Arm Type
Experimental
Arm Description
Patients in the healing statements group will be read healing statements during anesthesia induction, prior to undergoing surgery.
Arm Title
No Healing Statements
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Healing Statements
Intervention Description
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."
Primary Outcome Measure Information:
Title
Baseline Pain (analyzed by VAS Numeric Pain Distress Scale)
Description
Pain
Time Frame
baseline
Title
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
Description
Pain
Time Frame
6 hours after surgery
Title
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
Description
Pain
Time Frame
24 hours after surgery
Title
Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)
Description
Pain
Time Frame
2 weeks after surgery
Secondary Outcome Measure Information:
Title
Post operative Nausea and Vomiting (analyzed by Post-Operative Nausea and Vomiting Intensity Scale)
Description
Nausea and Vomiting
Time Frame
6 hours after surgery and 24 hours after surgery
Title
Time to First Bowel Movement
Description
Bowel Movement
Time Frame
Followed for 2 weeks after surgery
Title
Time to Pass Void Trial (Urination)
Description
Urination
Time Frame
Followed for 2 weeks after surgery
Title
Patient Perception of Improvement
Description
Patient Perception of Improvement measured by Patient Global Perception of Improvement Scale
Time Frame
2 weeks after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Iglesia, MD
Organizational Affiliation
Medstar Washington Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2900410
Citation
Evans C, Richardson PH. Improved recovery and reduced postoperative stay after therapeutic suggestions during general anaesthesia. Lancet. 1988 Aug 27;2(8609):491-3. doi: 10.1016/s0140-6736(88)90131-6.
Results Reference
result
PubMed Identifier
1952199
Citation
Block RI, Ghoneim MM, Sum Ping ST, Ali MA. Efficacy of therapeutic suggestions for improved postoperative recovery presented during general anesthesia. Anesthesiology. 1991 Nov;75(5):746-55. doi: 10.1097/00000542-199111000-00005.
Results Reference
result
PubMed Identifier
1547052
Citation
Liu WH, Standen PJ, Aitkenhead AR. Therapeutic suggestions during general anaesthesia in patients undergoing hysterectomy. Br J Anaesth. 1992 Mar;68(3):277-81. doi: 10.1093/bja/68.3.277.
Results Reference
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PubMed Identifier
2224266
Citation
McLintock TT, Aitken H, Downie CF, Kenny GN. Postoperative analgesic requirements in patients exposed to positive intraoperative suggestions. BMJ. 1990 Oct 6;301(6755):788-90. doi: 10.1136/bmj.301.6755.788.
Results Reference
result
Citation
Huddleston P. Prepare for Surgery, Heal Faster: A Guide of Mindy-Body Techniques. Angel River Press, 2012.
Results Reference
result
Citation
Watters M, Feldman J, Schoetz D, Abrams M, Goy C, Catman M, Huddleston P. The Power of Relaxation: A Holistic Approach to Preoperative Patient Education.
Results Reference
result
Citation
Huddleston M, Bierbaum B. Cost-effectiveness of Using Mind-Body Techniques for Total Knee-Joint Replacement.
Results Reference
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Citation
Hutchings DD. The value of suggestion given under anesthesia: A report and evaluation of 200 cases. American Journal of Clinical Hypnosis 1961; 26-29.
Results Reference
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Citation
Furlong M. Positive suggestions presented during anaesthesia. Memory and Awareness in Anaesthesia (Amsterdam: Swets & Zeitlinger, 1990).
Results Reference
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PubMed Identifier
10562780
Citation
Lebovits AH, Twersky R, McEwan B. Intraoperative therapeutic suggestions in day-case surgery: are there benefits for postoperative outcome? Br J Anaesth. 1999 Jun;82(6):861-6. doi: 10.1093/bja/82.6.861.
Results Reference
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Citation
Wolfe LS, Millet JB. Control of postoperative pain by suggestion under general anesthesia. American Journal of Clinical Hypnosis 1960; 3:109-112.
Results Reference
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Citation
Steinberg ME, Hord AH, Reed B, Sebels PS. Study of the effect of intraoperative analgesia and well-being. Memory and Awareness in Anesthesia (Englewood Cliffs, NJ: Prenctice Hall, 1993).
Results Reference
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PubMed Identifier
32541300
Citation
Shah NM, Andriani LA, Mofidi JL, Ingraham CF, Tefera EA, Iglesia CB. Therapeutic Suggestion in Postoperative Pain Control: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):409-414. doi: 10.1097/SPV.0000000000000906.
Results Reference
derived

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Healing Statements and Their Effect on Post Operative Pain

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