NCT02502357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2016

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

8 months

First QC Date

June 16, 2015

Last Update Submit

August 19, 2020

Conditions

Pelvic Organ Prolapse

Keywords

pain controlhealing statementspelvic prolapse

Outcome Measures

Primary Outcomes (4)

  • Baseline Pain (analyzed by VAS Numeric Pain Distress Scale)

    Pain

    baseline

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

    Pain

    6 hours after surgery

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

    Pain

    24 hours after surgery

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

    Pain

    2 weeks after surgery

Secondary Outcomes (4)

  • Post operative Nausea and Vomiting (analyzed by Post-Operative Nausea and Vomiting Intensity Scale)

    6 hours after surgery and 24 hours after surgery

  • Time to First Bowel Movement

    Followed for 2 weeks after surgery

  • Time to Pass Void Trial (Urination)

    Followed for 2 weeks after surgery

  • Patient Perception of Improvement

    2 weeks after surgery

Study Arms (2)

Healing Statements

EXPERIMENTAL

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

Other: Healing Statements

No Healing Statements

NO INTERVENTION

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.

Interventions

Healing StatementsOTHER

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."

Healing Statements

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (13)

  • 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.

    PMID: 2900410RESULT

  • 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.

    PMID: 1952199RESULT

  • 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.

    PMID: 1547052RESULT

  • 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.

    PMID: 2224266RESULT

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

    RESULT

  • 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.

    RESULT

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

    RESULT

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

    RESULT

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

    RESULT

  • 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.

    PMID: 10562780RESULT

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

    RESULT

  • 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).

    RESULT

  • 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.

    PMID: 32541300DERIVED

MeSH Terms

Conditions

Pelvic Organ ProlapseAgnosia

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Cheryl Iglesia, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
simple randomization
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2015

First Posted

July 20, 2015

Study Start

July 1, 2015

Primary Completion

March 8, 2016

Study Completion

September 14, 2016

Last Updated

August 21, 2020

Record last verified: 2020-08

Locations

US(1)