Healing Statements and Their Effect on Post Operative Pain

Pelvic Organ Prolapse Clinical Trial

— PHSPOPC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502357
• Other study ID #: 2015-043
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: September 14, 2016

Study information

• Verified date: August 2020
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 14, 2016
• Est. primary completion date: March 8, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Pelvic Organ Prolapse
• Prolapse

Intervention

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."

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View Citation

Furlong M. Positive suggestions presented during anaesthesia. Memory and Awareness in Anaesthesia (Amsterdam: Swets & Zeitlinger, 1990).

Huddleston M, Bierbaum B. Cost-effectiveness of Using Mind-Body Techniques for Total Knee-Joint Replacement.

Huddleston P. Prepare for Surgery, Heal Faster: A Guide of Mindy-Body Techniques. Angel River Press, 2012.

Hutchings DD. The value of suggestion given under anesthesia: A report and evaluation of 200 cases. American Journal of Clinical Hypnosis 1961; 26-29.

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. — View 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. — View 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. — View 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).

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.

Wolfe LS, Millet JB. Control of postoperative pain by suggestion under general anesthesia. American Journal of Clinical Hypnosis 1960; 3:109-112.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Pain (analyzed by VAS Numeric Pain Distress Scale)	Pain	baseline
Primary	Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)	Pain	6 hours after surgery
Primary	Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)	Pain	24 hours after surgery
Primary	Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)	Pain	2 weeks after surgery
Secondary	Post operative Nausea and Vomiting (analyzed by Post-Operative Nausea and Vomiting Intensity Scale)	Nausea and Vomiting	6 hours after surgery and 24 hours after surgery
Secondary	Time to First Bowel Movement	Bowel Movement	Followed for 2 weeks after surgery
Secondary	Time to Pass Void Trial (Urination)	Urination	Followed for 2 weeks after surgery
Secondary	Patient Perception of Improvement	Patient Perception of Improvement measured by Patient Global Perception of Improvement Scale	2 weeks after surgery