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

13. juli 2012 oppdatert av: Mona Sawhney, University of Toronto

The Effect of an Individualized Education Intervention Versus Usual Care on Pain Following Ambulatory Inguinal Hernia Repair

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

82

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Individuell opplæring
Atferdsmessig: 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.
Andre navn:
  • akutt smerte
  • inginal hernia repair
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
The primary outcome measure is pain intensity using a 0 to 10 numeric rating scale.
Tidsramme: Second post-operative day
Second post-operative day

Sekundære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: 7 days after surgery
7 days after surgery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Toronto

Samarbeidspartnere

Unity Health Toronto

Etterforskere

  • Hovedetterforsker: Judy Watt-Watson, RN, PhD, University of Toronto

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2009

Primær fullføring (Faktiske)

1. januar 2011

Studiet fullført (Faktiske)

1. juli 2012

Datoer for studieregistrering

Først innsendt

4. februar 2010

Først innsendt som oppfylte QC-kriteriene

4. februar 2010

Først lagt ut (Anslag)

5. februar 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

16. juli 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juli 2012

Sist bekreftet

1. juli 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 24390
  • 09-123c (Annen identifikator: St. Michael's Hospital)

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