Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
NCT Number: NCT02502357
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Washington D.C., District of Columbia, 20010, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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."
Time frame: baseline
Pain
Time frame: 6 hours after surgery
Pain
Time frame: 24 hours after surgery
Pain
Time frame: 2 weeks after surgery
Pain
Time frame: 6 hours after surgery and 24 hours after surgery
Nausea and Vomiting
Time frame: Followed for 2 weeks after surgery
Bowel Movement
Time frame: Followed for 2 weeks after surgery
Urination
Time frame: 2 weeks after surgery
Patient Perception of Improvement measured by Patient Global Perception of Improvement Scale
Medstar Health Research Institute
Other
The Power of Healing Statements on Post Operative Pain Control: A Randomized Controlled Trial
Acronym: PHSPOPC
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.
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