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Guided IMagery and Patient Satisfaction (GIMPS) Following Urogynecological Surgery (GIMPS)

27. juli 2017 opdateret af: Elizabeth Mueller, Loyola University

Guided IMagery and Patient Satisfaction Following Urogynecological Surgery

We hypothesize that women who use GIM pre-operatively will feel more prepared for surgery, have less anxiety on the day of surgery and have higher satisfaction scores 6 weeks after surgery compared to women who undergo our routine pre-operative care.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

Guided imagery (GIM) is a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state. In clinical settings, it was originally found effective in treating patients suffering primarily from emotional or psychological issues by using descriptive language and the five senses to help the patient visualize their desired change or outcome (1, 2). More recently, GIM has been incorporated into chemotherapy and surgical settings. While it has not been conclusively found to improve outcomes, patients who received GIM reported feeling less anxious, less nausea following chemotherapy, slightly shorter surgical recovery times and a higher quality of life (3-8). While these studies suggest exciting prospects for the incorporation of GIM into the normal pre-op routine, we believe that they have left out one integral piece of the puzzle. We have previously found that patients who feel "unprepared" for surgery have less post-operative satisfaction (9). We propose that the stress and anxiety of the unknown during a patient's surgical experience can make them feel unprepared for surgery. Therefore, the same techniques that have been previously shown to decrease these symptoms in chemotherapy treatment and surgery should help patients feel more prepared, and therefore more satisfied with their surgical experience. This key finding would give sufficient support for the incorporation of GIM into the pre-op routine of any surgical patient, and may prove to be a successful vehicle for increasing the overall satisfaction of any hospital's patient population.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

44

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Illinois
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University 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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • routine vaginal or laparoscopic surgery for pelvic organ prolapse planned ≥ 1 week from enrollment
  • a planned overnight hospital stay
  • commitment to listen to a 15 minute audio Compact Disc daily
  • proficiency in English.

Exclusion Criteria:

  • Not having routine vaginal or laparoscopic surgery for pelvic organ prolapse planned ≥ 1 week from enrollment
  • Not a planned overnight hospital stay
  • Unable to commitment to listen to a 15 minute audio Compact Disc daily
  • Not proficiency in English.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Guided IMagery (GIM)
If randomized to GIM, they will then be given an audio Compact Disc. Patients will be instructed to listen to the recording least once per day in a calm location during the week leading up to surgery. They will then be seen prior to surgery in the surgical waiting area where they will evaluated for anxiety, preparedness and study compliance.
It's a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state.
Ingen indgriben: Standard of Care (SOC)

Each participant will complete a baseline set of questionnaires. The Pelvic Floor Distress Inventory (PFDI) is a 20 question self-administered questionnaire on the presence and both of pelvic floor symptoms .

The Pelvic Organ Prolapse Quantification System (POPQ) measures the topography of the vagina and is considered to be gold standard for quantifying prolapse .

The State-Trait Anxiety Inventory (STAI) has been used extensively in research and clinical practice since its introduction in 1966 and is the most widely cited measure of anxiety.

New measurements at the 6-week follow-up appointment will include the Patient Global Impression of Improvement (PGII), and a postoperative questionnaire eliciting overall satisfaction and development of new pelvic symptoms.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in patient satisfaction with urogynecological surgery when using GIM (questionnaire)
Tidsramme: 6 weeks
Women will report their satisfaction with their surgical experience 6 weeks after surgery using a 10-point Likert scale.
6 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in patient sense of preparedness when using GIM (questionnaire)
Tidsramme: 6 weeks
Preparedness will be measured at baseline, day of surgery, and 6 weeks after surgery to determine how GIM affected patient preparedness. It will be measured using a 10-point Likert scale
6 weeks
Change in patient anxiety about surgery when using GIM (questionnaire)
Tidsramme: 6 week
Patient anxiety will be measured at baseline, day of surgery and at 6 weeks post op to determine how GIM affected anxiety. It will be measured using the State-Trait Anxiety Inventory (STAI), which has been used extensively in research and clinical practice since its introduction in 1966 and is the most widely cited measure of anxiety.
6 week

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Elizabeth Mueller, MD, Loyola University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. juni 2014

Primær færdiggørelse (Faktiske)

1. februar 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

5. juni 2014

Først indsendt, der opfyldte QC-kriterier

13. juni 2014

Først opslået (Skøn)

17. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 206481

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

Kliniske forsøg med Prolaps af bækkenorganer

Kliniske forsøg med Guided IMagery (GIM)

3
Abonner