The Effect of an Individualized Education Intervention on Pain Following Inguinal Hernia Repair Surgery

NCT01063790 | Completed Early Phase 1

• 2 other identifiers: 2439009-123c
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Pain after inguinal hernia repair surgery is common with more than 50% of patients reporting moderate to severe acute pain following surgery. Analgesics are helpful in managing this pain but patients can be reluctant to take analgesics due to potential adverse effects such as nausea, vomiting or constipation. Patients may also be concerned about addiction to analgesics or they may believe that experiencing moderate to severe pain after surgery is to be expected. The purpose of this study is to investigate the impact of an individualized education program regarding pain and management of adverse effects on pain after inguinal hernia repair surgery.

Conditions

Pain

Keywords

Post-operative pain; inguinal hernia repair surgery; Patient education

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is pain intensity using a 0 to 10 numeric rating scale.

  Second post-operative day

Secondary Outcomes (1)

• Secondary measures include: quality of pain, pain related interference, analgesic use, prevalence and intensity of adverse effects of analgesics, patient concerns regarding pain management, and adequacy of post-discharge information.

  7 days after surgery

Study Arms (2)

Usual care

NO INTERVENTION

Patients undergoing elective inguinal hernia repair attend the pre-admission clinic no later than one week prior to surgery. During this visit they receive one-on-one pre-operative education from a registered nurse. It includes both verbal and written information. Verbal information provided to patients includes procedural information such as the admission process, and post-operative care in the post-anaesthetic care uni and day surgery unit. Post-discharge pain management information is minimal and consists of direction to not wait until the pain is severe before taking prescribed analgesics.

Individualized Education

EXPERIMENTAL

Behavioral: Individualized Education

Interventions

Individualized Education BEHAVIORAL

The intervention consists of written information in the form of a booklet, an individualized face to face education session and two telephone support calls regarding post-discharge pain management, adverse effects of analgesics and common concerns about asking for help with pain.Participants in the intervention group will also receive two telephone support calls. The purpose of the telephone support calls is to readdress the information that patients received in the booklet and to clarify concerns regarding post-operative pain management that were discussed during the individualized education session.

Also known as: inginal hernia repair, acute pain

Individualized Education

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male
• able to speak, read and understand English,
• have telephone access.
• are scheduled for a unilateral inguinal hernia repair.

You may not qualify if:

• patients scheduled for a repeat IHR on the same surgical side
• patients who have emergency surgery.
• patients undergoing bilateral inguinal hernia repair.

Sponsors & Collaborators

• University of Toronto: lead
• Unity Health Toronto: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Pain Clinics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Outpatient Clinics, Hospital; Ambulatory Care Facilities; Health Facilities; Health Care Facilities Workforce and Services; Hospital Departments; Hospital Administration; Health Facility Administration; Organization and Administration; Health Services Administration

Study Officials

• Judy Watt-Watson, RN, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: October 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: July 1, 2012
• Last Updated: July 16, 2012

Record last verified: 2012-07

Locations

CA (1)