- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04111861
Singing for Chronic Pain, a New Intervention for the Management of Chronic Pain
Singing for Chronic Pain, a Pilot Study of a New Intervention for the Management of Chronic Pain
The aim of the project is to determine the feasibility of delivering a Singing for Chronic Pain (SCP) programme to patients with chronic pain attending a pain clinic.
The investigator will also be looking to provide a preliminary estimate of the benefit of SCP on self-efficacy, self -management skills, mindfulness and well-being as measured by standardized outcome measures.
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Josephine Erwin
- Telefonnummer: 01872 256439
- E-post: josephine.erwin@nhs.net
Studiesteder
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Cornwall
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Truro, Cornwall, Storbritannia, TR1 3HD
- Rekruttering
- Royal Cornwall Hospital
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Ta kontakt med:
- Jo Erwin
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 18 years of age or older and have a diagnosis of chronic pain with a duration of 6 months or more.
Exclusion Criteria:
- Having a mental health and/or physical health diagnosis that might prevent active engagement/participation in group sessions; Severe hearing impairment; Severe/profound cognitive impairment that may limit active engagement/participation in group sessions.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Intevention
To see if singing can be used as a detractive method from patients experiencing ongoing pain.
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To investigate whether singing can help people to manage their chronic pain the applicants, working together with people with chronic pain, have developed a singing intervention, Singing for Chronic Pain (SCP).
The development of the programme has been supported by Snape Moultings, an international centre for the arts which offered the team a residency to develop the programme (https://snapemaltings.co.uk/music/residencies/).
The model takes a holistic approach using voice and singing, movement, sound, mindfulness and breath work to provide opportunities to connect body, voice, breath and mind.
This is important given that people often use body dissociation as a way to cope with physical pain
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Completion rate
Tidsramme: One year
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Measure of attendance at sessions
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One year
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Consent rate
Tidsramme: One year
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Measure of those offered the programme who consent to take part
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One year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Self reported self efficacy
Tidsramme: One year
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Pain Self-efficacy questionnaire
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One year
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Self reported ability to self-manage pain
Tidsramme: One year
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Patient Activation Measure questionnaire
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One year
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Increased mindfulness Increased mindfulness Increased mindfulness
Tidsramme: One year
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Frieburg Mindfulness questionnaire
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One year
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Self reported well-being
Tidsramme: One year
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Edinburgh Warwick Well-being questionnaire
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One year
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Self reported anxiety depression
Tidsramme: One year
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Hospital Anxiety and Depression questionnaire.The HADS is a fourteen item scale that generates ordinal data.
Seven of the items relate to anxiety and seven relate to depression.
Anxiety scores and depression scores can range for 0 -21 with a higher score being worse.
The separate depression and anxiety scores scores can be combined to give an overall score.
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One year
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Self reported quality of life
Tidsramme: One year
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EQ5D Quality of Life Questionnaire The EQ-5D questionnaire has two components: health state description and evaluation.Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) or five-level (EQ-5D-5L) scale. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).he answers given to ED-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). |
One year
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Patient Focus Group
Tidsramme: One year
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At week 10, participants will be invited to take part in a 60 minute focus group led by an experienced researcher.
The focus groups will explore participants' perception of the programme and its outcomes, reasons for noncompliance, instrument appropriateness and suggestions for programme improvement
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One year
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2019 RCHT 61
Legemiddel- og utstyrsinformasjon, studiedokumenter
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