Cristin-prosjekt-ID: 544947
Registrert av: REK Sist endret: 4. mai 2020, 07:41 Sist endret av: REK

Cristin-prosjekt-ID: 544947
Registrert av: REK Sist endret: 4. mai 2020, 07:41 Sist endret av: REK
Prosjekt

Munnstell med salviete som munnskyllemiddel

prosjektleder

Anners Lerdal
ved Lovisenberg Diakonale Sykehus

prosjekteier / koordinerende forskningsansvarlig enhet

  • Lovisenberg Diakonale Sykehus

forskningsansvarlige enheter

  • Lovisenberg Diakonale Sykehus

Godkjenninger

  • Regionale komitéer for medisinsk og helsefaglig forskningsetikk (REK) - 2013/1531

Klassifisering

Vitenskapsdisipliner

Medisinske fag

Emneord

Hospice diakoni • Randomiserte kontrollerte studier • Palliasjon • Orale bivirkninger av kreftbehandling • Kreft • Munnstell

HRCS-helsekategori

  • Kreft
  • Munnhule, mage-tarm

HRCS-forskningsaktivitet

  • 6 Evaluering av behandlinger og terapeutiske intervensjoner
  • 7 Håndtering av sykdommer og tilstander
  • 7.2 Omsorg ved livets slutt

Kategorier

Prosjektkategori

  • Anvendt forskning
  • Bidragsprosjekt

Helseprosjekttype

Annet studium

Kontaktinformasjon

Sted
Ragnhild Elisabeth Monsen

Tidsramme

Aktivt
Start: 1. januar 2014 Slutt: 1. januar 2024

Beskrivelse Beskrivelse

Tittel

Munnstell med salviete som munnskyllemiddel

Populærvitenskapelig sammendrag

Hospice Lovisenberg har gjennom flere år brukt salviete som munnskyllemiddel i behandling av ubehag i munnen hos alvorlig syke og døende pasienter. Hensikten med studien er å undersøke om salviete er mere effektiv i forebygging og behandling av pasienters ubehag fra munnhulen enn saltvann. Studien skal gjennomføres på pasienter ved Hospice Lovisenberg og inkludere 88 pasienter. Forsøket med de to type munnskyllemidlene skal foregå over 4 dager. Deltagerne i studien vil få spørsmål om generell helse og livskvalitet og det samles inn data om røykvaner og inntak av mat og drikke. Det innhentes også opplysninger fra pasientens journal. Tannlege observerer munnhulen og det tas bilde både før og etter forsøket. Det primære er pasienten sin subjektive opplevelse av behandlingen og de skal daglig fylle ut spørreskjema.

Tittel

A comparison of the effectiveness of normal saline mouthwash and mouthwash based on tea solution from Salvia Officinalis(SO) in palliative care. A randomized controlled trial.

Vitenskapelig sammendrag

Oral discomfort is a common complain among patients in hospice facilities and may affect the quality of life. Terminally ill patients may suffer from oral discomfort and pain, coated mouth and tongue, mouth sores, oral infections, denture-related problems and xerostomia. At Hospice Lovisenberg tea solutions made from the herb Salvia officinalis (SO) have been used for over 10 years as a mouth rinse solution in oral care. There are indications that this mouth rinse has beneficial effects on oral comfort and have reduced oral complications.

Studies documenting the effectiveness of oral care products and rinsing solutions often focus on patients receiving cancer treatment, to prevent, cure or reduce distressing side effect from treatments. Distressing oral complications are well documented among patients in palliative care, but little research has been undertaken regarding treatment of these specific complications.

This study examines the effectiveness of an herbal mouthwash made from salvia officinalis (SO) in maintaining good oral health among patients in palliative care. It is hypothesized that using the mouthwash made from SO will result in better oral health and more oral comfort than using with conventional normal saline mouthwash. 

The aim of this study is to examine the effectiveness of a herbal mouthwash made from SO in maintaining good oral health among patients in palliative care. The study compares a mouthwash based on salvia tea solution with conventional normal saline mouthwash and addresses the following research questions:

  1. Does the SO-based mouthwash provide a better treatment than conventional normal saline in maintaining good oral health in terminally ill patients?
  2. Is there a difference in the individual perception of oral comfort in patients receiving SO versus patients receiving saline rinsing solution?

This is a single blinded randomized, controlled study, addressed in a prospective design. Patients with oral discomfort will be introduced to the project by nursing staff at the hospice, enrolled consecutively and randomized into 2 comparable study groups. Data collection will be carried out before, during and after treatment. The study period will be 4 days.

Data will be collected from medical records, self-reporting questionnaires and by visual examination of the oral cavity performed by a dentist at baseline and after the intervention.

The patient will, during the course of the study, answer questionnaires and undergo oral examinations. Some information collected in the study is currently collected from all residential patients at Hospice Lovisenberg in order to provide best possible care, and will not involve extra burden for the patient in the study. Additional questions will be asked before, during and after the study. A swab-test will also be performed in order to detect oral infections.

 

Metode

The study was a prospective, single-blinded, block-randomized controlled trial to evaluate the effect of an SO-based mouth rinse on the oral health of patients with advanced cancer in palliative care in comparison to the current standard of care. The data were collected from inbed patients at Hospice Lovisenberg in Oslo, Norway. The Regional Comittee for Medical Research Ethics, Health Region South-East Norway, approved the study in October 2013 (reference #2013/1531). The study was registered with ClinicalTrials.grov in February 2014.

The randomization was performed in three blocks of 20 subjects and a final block of 28 subjects. An analysis was conducted after the first two blocks (n=40) to determine whether there were sufficient beneficial effects from the SO rinse to continue the study. The study nurses and the dentists were blinded in this study.

Data will be collected from medical records, self-reporting questionnaires and by visual examination of the oral cavity performed by a dentist.

Information from medical records:

  • Diagnosis, present and previous medication and treatment will be assessed from medical records.
  • Body Mass Index
  • Blood test results
  • Scores from The Edmonton Symptom Assessment System (ESAS).

Information collected from patient:

  • Smoking habits
  • Questions regarding diets
  • Numeric rating scale regarding oral pain, xerostomia, swallowing problems, oral discomfort, patients’ experience of the rinsing solution.
  • Questions from EORTC-OH17
  • EORTC-C15-PAL

Information collected from health care personnel after patient examination:

  • Karnofsky Performance Status
  • Oral Mucositis Assessment Scale
  • Evaluation of dental status
  • Questions assessing level of coated tongue and mucosa

 

In order to detect oral Candida infection, a swab-test will be performed during the dental examination prior to and following the study treatment.

Both groups will follow the same mouth-care procedure and treatment frequency, but with different rinsing solution. The procedure will include dental cleaning, preferably with a toothbrush and recommended toothpaste morning and evening, and rinsing of the oral cavity with a rinsing solution, application of oral gel (biotene) on the mucosa for relief of dry mouth and lubricant to maintain lip moisture four times a day during intervention period.

prosjektdeltakere

prosjektleder
Aktiv cristin-person

Anners Lerdal

  • Tilknyttet:
    Prosjektleder
    ved Lovisenberg Diakonale Sykehus
Aktiv cristin-person

Ragnhild Elisabeth Monsen

  • Tilknyttet:
    Prosjektdeltaker
    ved Lovisenberg Diakonale Sykehus
Aktiv cristin-person

Bente Brokstad Herlofson

  • Tilknyttet:
    Prosjektdeltaker
    ved Det odontologiske fakultet ved Universitetet i Oslo

Katrine Gahre Fjeld

  • Tilknyttet:
    Prosjektdeltaker
    ved Det odontologiske fakultet ved Universitetet i Oslo
Aktiv cristin-person

Anita Tollisen

  • Tilknyttet:
    Prosjektdeltaker
    ved Lovisenberg Diakonale Sykehus
  • Tilknyttet:
    Prosjektdeltaker
    ved Universitetet i Oslo
  • Tilknyttet:
    Prosjektdeltaker
    ved Klinikk for Medisin ved Lovisenberg Diakonale Sykehus
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Resultater Resultater

Dry mouth - a missing symptom in multiple assessment tools?

Monsen, Ragnhild Elisabeth; Herlofson, Bente Brokstad; Gay, Caryl; Dahl, Marianne; Saghaug, Elisabeth; Slaaen, Joran; Lerdal, Anners. 2019, 16th World Congress of the European Association for Palliative Care. UIO, LDSPoster

A comparison of normal saline mouth rinse and mouth rinse based on Salvia officinalis in palliative care: A randomized controlled trial.

Monsen, Ragnhild Elisabeth; Herlofson, Bente Brokstad; Gay, Caryl; Fjeld, Katrine Gahre; Hove, Lene Hystad; Saghaug, Elisabeth; Slaaen, Joran; Sundal, Tone; Tollisen, Anita; Lerdal, Anners. 2019, 16th World Congress of the European Association for Palliative Care. LDS, UIOPoster

Rekruttering av pasienter til en klinisk intervensjonsstudie i et Hospice.

Monsen, Ragnhild Elisabeth; Herlofson, Bente Brokstad; Gay, Caryl; Saghaug, Elisabeth; Tollisen, Anita; Fjeld, Katrine Gahre; Hove, Lene Hystad; Tallang, Oddveig Utheim; Sundal, Tone; Lerdal, Anners. 2018, Landskonferansen i palliasjon. UIO, LDSVitenskapelig foredrag

Oral health symptoms that interfere with eating and drinking among hospice patient.

Gay, Caryl; Monsen, Ragnhild Elisabeth; Saghaug, Elisabeth; Herlofson, Bente Brokstad; Fjeld, Katrine Gahre; Hove, Lene Hystad; Tollisen, Anita; Sundal, Tone; Tallang, Oddveig Utheim; Slaaen, Joran mfl.. 2017, 15. World Congress of the European Association for Palliative Care. LDS, UIOPoster

Munntørrhet hos palliative pasienter - en randomisert kontrollert studie i en hospiceenhet.

Monsen, Ragnhild Elisabeth; Saghaug, Elisabeth; Herlofson, Bente Brokstad; Fjeld, Katrine Gahre; Hove, Lene Hystad; Tallang, Oddveig Utheim; Tollisen, Anita; Sundal, Tone; Slaaen, Joran; Lerdal, Anners. 2016, Sykepleierkongressen 2016. UIO, LDSPoster
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