- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01562964
Hypnotherapy in Patients With Chest Pain & Unobstructed Coronaries
29. august 2018 opdateret af: Imperial College London
The Impact of Hypnotherapy on Symptoms, Psychological Morbidity and Quality of Life in Postmenopausal Women With Chest Pain and Unobstructed Coronary Arteries
This study will investigate whether clinical hypnotherapy can effectively treat chest pain symptoms, improve emotional wellbeing and quality of life in postmenopausal women with chest pain and coronary arteries without any narrowings.
The diagnosis of chest pain with 'normal' coronary arteries is found in 25% of patients undergoing investigation of chest pain using coronary angiography (when dye is injected into the coronary arteries whilst xray pictures are taken), and the majority of these patients are postmenopausal women.
Often there is no obvious physical cause.
Despite symptoms being treated using conventional drugs, and life expectancy is not affected, many patients continue to suffer from debilitating chest pain symptoms, frequently resulting in visits to hospital, increased psychological illness and poor quality of life.
The investigators are interested in finding ways of improving not only chest pain symptoms but also psychological wellbeing and quality of life in these patients.
Previous studies of ours have found improvement in these patients after taking part in a support group, and using a relaxation technique called Autogenic training.
Recently the investigators conducted a pilot study which showed a favourable effect of hypnotherapy on physical ability, well-being and quality of life.
The investigators would now like to extend this study, performing a larger randomised, controlled trial.
The investigators hypothesise that hypnotherapy will beneficially affect symptoms and quality of life in patients with cardiac Syndrome X.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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London, Det Forenede Kongerige, SW3 6NP
- Royal Brompton & Harefield NHS Foundation Trust
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- history of chest pain for ≥ 2 years
- ≥ 2 episodes chest pain per week
- angiographically smooth epicardial coronary arteries
- Willing to give written informed consent
Exclusion Criteria:
- Any epicardial coronary atheroma on angiography of the coronary arteries
- left ventricular hypertrophy or dysfunction (clinical/ECG/echo/CXR)
- previous hypnotherapy for chest pain symptoms
- participation in research project within previous 60 days
- unwilling to give written informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Hypnotherapy
Hypnotherapy will be conducted at the Royal Brompton Hospital by a qualified practician (DF).
Ten pain control hypnotherapy session will run for 50-60 minutes each.
In the first session a thorough history will be taken of the patient's chest pain history together with both the sensory and affective components of their pain.
If there is time, relaxation technique and self-hypnosis will be taught at this visit.
In subsequent sessions, various techniques, including techniques that focus on direct suggestions and imagery work, will be applied and taught to the patient.
The pain control techniques are all analgesic in nature - focusing on the reduction, but not the total removal of the pain.
A small amount of pain is left behind to serve as a reminder that either something is wrong or that the patient needs to take it easy.
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Ten pain control hypnotherapy session will run for 50-60 minutes each.
In the first session a thorough history will be taken of the patient's chest pain history together with both the sensory and affective components of their pain.
If there is time, relaxation technique and self-hypnosis will be taught at this visit.
In subsequent sessions, various techniques, including techniques that focus on direct suggestions and imagery work, will be applied and taught to the patient.
The pain control techniques are all analgesic in nature - focusing on the reduction, but not the total removal of the pain.
A small amount of pain is left behind to serve as a reminder that either something is wrong or that the patient needs to take it easy.
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Aktiv komparator: Supportive therapy
Subjects in the Supportive therapy group will attend the Royal Brompton Hospital weekly for 10 weeks to meet with person of equal status to the hypnotherapist (e.g. a research assistant, not a medical practitioner) trained to provide counseling and support.
Visits will last 50-60 min.
Patients will be encouraged to talk about their physical symptoms and any emotional issues, and to discuss how these might be coped with in a better way.
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Subjects in the Supportive therapy group will attend the Royal Brompton Hospital weekly for 10 weeks to meet with person of equal status to the hypnotherapist (e.g. a research assistant, not a medical practitioner) trained to provide counseling and support.
Visits will last 50-60 min.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Symptom frequency
Tidsramme: 24 weeks
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24 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Symptom severity
Tidsramme: 24 weeks
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24 weeks
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Psychological morbidity
Tidsramme: 24 weeks
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24 weeks
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General quality of life
Tidsramme: 24 weeks
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Using Short Form 36 questionnaire
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24 weeks
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Hospitalisations
Tidsramme: 24 weeks
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24 weeks
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Consultancy time
Tidsramme: 24 weeks
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24 weeks
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Medication use
Tidsramme: 24 weeks
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24 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Peter Collins, MD, FRCP, Imperial College London, and Royal Brompton & Harefield NHS Foundation Trust
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 (Faktiske)
1. februar 2012
Primær færdiggørelse (Faktiske)
2. marts 2012
Studieafslutning (Faktiske)
2. marts 2012
Datoer for studieregistrering
Først indsendt
22. marts 2012
Først indsendt, der opfyldte QC-kriterier
23. marts 2012
Først opslået (Skøn)
26. marts 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. august 2018
Sidst verificeret
1. august 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P40285
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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