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

This study has been completed.
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Mona Sawhney, University of Toronto
ClinicalTrials.gov Identifier:
NCT01063790
First received: February 4, 2010
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Pain
Behavioral: Individualized Education
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of an Individualized Education Intervention Versus Usual Care on Pain Following Ambulatory Inguinal Hernia Repair

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • The primary outcome measure is pain intensity using a 0 to 10 numeric rating scale. [ Time Frame: Second post-operative day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 7 days after surgery ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: October 2009
Study Completion Date: July 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Experimental: Individualized Education Behavioral: 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.
Other Names:
  • inginal hernia repair
  • acute pain

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063790

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
University of Toronto
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Judy Watt-Watson, RN, PhD University of Toronto
  More Information

No publications provided

Responsible Party: Mona Sawhney, PhD, University of Toronto
ClinicalTrials.gov Identifier: NCT01063790     History of Changes
Other Study ID Numbers: 24390, 09-123c
Study First Received: February 4, 2010
Last Updated: July 13, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
Post-operative pain
inguinal hernia repair surgery
Patient education

Additional relevant MeSH terms:
Hernia, Inguinal
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014