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

NCT ID: NCT01063790

Last Updated: 2012-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-07-31

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.

Detailed Description

There is clear evidence that patients who have undergone ambulatory inguinal hernia (IHR) repair have significant pain following surgery. Inguinal hernia repair has been identified as one of the most painful ambulatory surgery procedures, with 98% of patients reporting pain 24 hours following IHR surgery, and 54% of patients experiencing moderate to severe pain in the first 72 hours. Despite experiencing continued pain, patients do not always take the prescribed analgesics. Analgesics are helpful in managing post-operative pain but may have adverse effects, including nausea, vomiting or constipation, which are often not managed. Almost half of all patients who undergo ambulatory surgery experience these adverse effects with 45% experiencing constipation and 46% experiencing nausea and/or vomiting in the first 48 hours after surgery.

As well, patients may have concerns about addiction, or asking for help to manage their pain and may believe that moderate to severe pain is to be expected, contributes to healing and therefore is to be tolerated following surgery. Patients are expected to manage this pain and adverse effects of analgesics at home. Minimal research has been found regarding interventions to manage pain following ambulatory surgery, and none found specifically for patients undergoing inguinal hernia repair.

The purpose of this trial is to investigate the impact of an individualized pre-operative pain education intervention that includes a booklet with telephone support pre-operatively and after discharge home versus usual care for patients having IHR surgery. The primary outcome will be worst pain on movement in the past 24 hours and the secondary outcomes will be pain related interference, pain quality, analgesic use and adverse effects, and patient satisfaction and concerns with pain management.

Conditions

Pain

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Individualized Education

Group Type: EXPERIMENTAL

Individualized Education

Intervention Type: 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.

Interventions

Individualized Education

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

inginal hernia repair; acute pain

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Mona Sawhney

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judy Watt-Watson, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

09-123c

Identifier Type: OTHER

Identifier Source: secondary_id

24390

Identifier Type: -

Identifier Source: org_study_id