Skip to main content
OpenTrials
Completed

NCT Number: NCT02502357

Healing Statements and Their Effect on Post Operative Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington Hospital Center

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healing Statements

Other

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 outcomes

  1. Baseline Pain (analyzed by VAS Numeric Pain Distress Scale)

    Time frame: baseline

    Pain

  2. Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)

    Time frame: 6 hours after surgery

    Pain

  3. Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)

    Time frame: 24 hours after surgery

    Pain

  4. Post Operative Pain (analyzed by VAS Numeric Pain Distress Scale)

    Time frame: 2 weeks after surgery

    Pain

Secondary outcomes

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

    Time frame: 6 hours after surgery and 24 hours after surgery

    Nausea and Vomiting

  2. Time to First Bowel Movement

    Time frame: Followed for 2 weeks after surgery

    Bowel Movement

  3. Time to Pass Void Trial (Urination)

    Time frame: Followed for 2 weeks after surgery

    Urination

  4. Patient Perception of Improvement

    Time frame: 2 weeks after surgery

    Patient Perception of Improvement measured by Patient Global Perception of Improvement Scale

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

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

Acronym: PHSPOPC

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 20, 2015
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.