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Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?

15. februar 2011 opdateret af: Portland VA Medical Center

Study Objectives:

  • 1. To examine the extent to which noise typical of nursing units reduces speech intelligibility in acutely ill hospitalized patients
  • 2. To examine the extent to which noise typical of nursing units impairs recall in acutely ill hospitalized patients
  • 3. To quantify severity of reduced performance associated with age, familiarity with the healthcare setting, hearing and health status.

Plan:

One hundred and twenty inpatients from the four medical/surgical nursing units at the Portland VA Medical Center, 60 with normal hearing and 60 with hearing impairment will be recruited to participate in the study. Following assessment to ascertain eligibility and obtaining informed consent, patients will be tested in a sound booth housed at the National Center for Rehabilitative Auditory Research (NCRAR). Designed so that each patient serves as his or her own control, we can accommodate considerable baseline variability between patients without adversely affecting required sample size. Patients' performance in speech intelligibility and recall tests will be measured using a constant level of speech, in controlled environments of no noise (baseline), white noise, hospital noise and hospital noise with speech, all delivered via headphones in pseudo-random order. Performance will be measured in each type of noise at decibel levels equivalent to those currently experienced on nursing units and at lower levels that prior studies have shown are more conducive to effective communication

By selecting measures that are particularly relevant to the safe care of hospitalized patients, and that have been studied extensively in healthy populations in highly controlled conditions, we expect to find compelling and unambiguous evidence that hospitalized patients correctly hear and recall very little of what is said to them during their hospitalizations. The majority of hospitalized patients stay on acute care nursing units during most or all of their hospitalizations, making this an appropriate population to study in the context of their responses to the noises typical in these environments. Perhaps most importantly, this study will heighten awareness of health-care personnel to the levels of impairment suffered by their patients - both in their ability to correctly interpret speech and to recall it - in the typical noisy environments of nursing units.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

84

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Portland VA Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 88 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Adult inpatients on medical/surgical nursing units at the Portland VA, greater than 18 years of age will be eligible to participate.

Exclusion criteria for 60 participants with hearing impairment:

  • Cognitively or physically unable to participate (reported by patient or nurse); electronic chart notes indicate patient exhibits aggressive behavior, documented dementia, Alzheimer's disease, or severe psychosocial disorder, patient undergoing detoxification, individual is not legally capable of independently providing informed consent
  • Patients who are not native American English speakers.
  • Patients who exhibit Meniere's disease or retrocochlear disorder based on patient report or notes in patient's chart.
  • Patient exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, immittance or notes in patient chart; 5) patients unwilling to participate.

Exclusion criteria for the other 60 participants:

  • Cognitively or physically unable to participate (reported by patient or nurse); electronic chart notes indicate patient exhibits aggressive behavior, documented dementia, Alzheimer's disease, or severe psychosocial disorder, patient undergoing detoxification, individual is not legally capable of independently providing informed consent
  • Patients who are not native American English speakers.
  • Patients who exhibit Meniere's disease or retrocochlear disorder based on patient report or notes in patient's chart.
  • Patient exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, immittance or notes in patient chart.
  • Patients with hearing loss that exceeds 25 dBHL in any frequency between .l5 and 3 kHz.
  • Patients unwilling to participate.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 1
hearing impaired inpatients
no noise
noise without speech
noise with speech present
Andet: 2
Non-hearing-impaired inpatients
no noise
noise without speech
noise with speech present

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in the percent of correctly identified words at different signal-to-noise rations (levels +4, +8 and +12 db) above that of the two types of noise, relative to the percent identified in quiet
Tidsramme: immediately after presentation
immediately after presentation

Sekundære resultatmål

Resultatmål
Tidsramme
Change in the percent of correctly recalled words at different signal-to-noise rations (levels +4, +8 and +12 db) above that of the two types of noise, relative to the percent recalled in quiet
Tidsramme: five minutes after presentation
five minutes after presentation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Diana S Pope, PhD, MS, RN, Portland VA Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2010

Primær færdiggørelse (Faktiske)

1. december 2010

Studieafslutning (Faktiske)

1. december 2010

Datoer for studieregistrering

Først indsendt

9. juni 2008

Først indsendt, der opfyldte QC-kriterier

9. juni 2008

Først opslået (Skøn)

11. juni 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. februar 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2011

Sidst verificeret

1. februar 2011

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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