Providing Patients Realistic Expectations of Postoperative Pain

NCT03434847 | Terminated

• 1 other identifier: 201709172
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, randomized, single-blind study, whether perioperative educational improves pain-related postoperative outcomes,

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Does perioperative education improve satisfaction with postoperative pain control at discharge?

  The satisfaction with postoperative pain control will be assessed using an initial, post-operative and discharge questionnaire of participant's pain level, medications (if any) to manage pain, the affects of that pain management, and participant satisfaction of that pain control.

  Upon discharge, Day 1 - Day 7

Study Arms (2)

Control

NO INTERVENTION

Standard preoperative assessment

Education

ACTIVE COMPARATOR

Pre-operative education regarding post-operative pain expectations

Other: Education

Interventions

Education OTHER

Participants who receive perioperative educational to address their expectation about their postoperative pain will have improved pain-related postoperative outcomes.

Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Undergoing open colorectal surgery Able to understand and sign and informed consent form

You may not qualify if:

• Age \< 18 years
• Unable to complete post-operative CMS questionnaire
• Inability to understand the English language Absolute contraindication to epidural placement (patient refusal, requiring resumption of therapeutic anticoagulation after surgery, anaphylaxis to local anesthetics, local or systemic infections, bleeding diathesis)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (7)

• Koenen P, Bathis H, Schneider MM, Frohlich M, Bouillon B, Shafizadeh S. How do we face patients' expectations in joint arthroplasty? Arch Orthop Trauma Surg. 2014 Jul;134(7):925-31. doi: 10.1007/s00402-014-2012-x. Epub 2014 May 24.

  PMID: 24858373 BACKGROUND

• Ghomrawi HM, Mancuso CA, Westrich GH, Marx RG, Mushlin AI; Expectations Discordance Study Group. Discordance in TKA expectations between patients and surgeons. Clin Orthop Relat Res. 2013 Jan;471(1):175-80. doi: 10.1007/s11999-012-2484-3.

  PMID: 22821348 BACKGROUND

• Waljee J, McGlinn EP, Sears ED, Chung KC. Patient expectations and patient-reported outcomes in surgery: a systematic review. Surgery. 2014 May;155(5):799-808. doi: 10.1016/j.surg.2013.12.015. Epub 2013 Dec 16.

  PMID: 24787107 BACKGROUND

• Shuldham C. A review of the impact of pre-operative education on recovery from surgery. Int J Nurs Stud. 1999 Apr;36(2):171-7. doi: 10.1016/s0020-7489(99)00010-3.

  PMID: 10376227 BACKGROUND

• Snyder-Ramos SA, Seintsch H, Bottiger BW, Motsch J, Martin E, Bauer M. Patient satisfaction and information gain after the preanesthetic visit: a comparison of face-to-face interview, brochure, and video. Anesth Analg. 2005 Jun;100(6):1753-1758. doi: 10.1213/01.ANE.0000153010.49776.E5.

  PMID: 15920209 BACKGROUND

• Kaur H, Singh G, Singh A, Sharda G, Aggarwal S. Evolving with modern technology: Impact of incorporating audiovisual aids in preanesthetic checkup clinics on patient education and anxiety. Anesth Essays Res. 2016 Sep-Dec;10(3):502-507. doi: 10.4103/0259-1162.177187.

  PMID: 27746541 BACKGROUND

• Noorian C, Aein F. Comparative investigation of the effectiveness of face-to-face verbal training and educational pamphlets on readiness of patients before undergoing non-emergency surgeries. J Educ Health Promot. 2015 May 19;4:45. doi: 10.4103/2277-9531.157231. eCollection 2015.

  PMID: 26097859 BACKGROUND

Related Links

• HCAHPS Patient Level Correlations

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Michael Bottros, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: At enrollment, each patient will be assigned a study number, which will match a previously prepared computer-generated list of randomization numbers to determine whether they will be in the intervention or control arm. Pre-operatively, all patients will complete an initial questionnaire. The patients in the intervention group (n=50) will, in addition to the standard pre-operative assessment, also receive pre-operative educational instruction of what to expect from a post-operative pain perspective including education material to take home. For this study, we will be using deception, with the reasoning that the patients' knowledge of the different education materials will affect their rating of the impact of the intervention on satisfaction scores.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, single-blind study

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: February 15, 2018
• Study Start: October 21, 2017
• Primary Completion: January 16, 2018
• Study Completion: January 16, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)