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The Influence of Mindfulness Based Intervention on Pain Perception in Chronic Pain Patients

28 czerwca 2015 zaktualizowane przez: Meir Medical Center

The Influence of Mindfulness Based Intervention on Pain Perception in Chronic Pain Patients Evaluating Personal Characteristics and Possible Mechanism

Background: Chronic pain is a common condition in the general population, causing great suffering in both physical and mental aspects. Previous research shows that mindfulness based interventions help chronic pain patients to cope better with their pain, and improve their quality of life. Although evidence support the efficacy of mindfulness based interventions for chronic pain, it is still unclear whether this efficacy involves a direct influence on sensory aspects of pain perception. Further more, the mechanisms of change responsible for the improved life quality and the possible moderating factors that may influence treatment efficacy, are still unknown.

Aim: The purpose of this study is to evaluate the efficacy of mindfulness based intervention on pain perception and quality of life in individuals suffering from chronic pain. The investigators will also evaluate potential mechanisms responsible for the change following mindfulness practice. Finally the investigators will examine the role of personal characteristics as potential moderating factors of mindfulness effect.

Hypothesis: The investigators hypothesize that 1) compared to a waitlist control group, chronic pain patients participating in a full mindfulness based program will report greater improvements in a) pain severity, b) quality of life and psychological symptoms, and c) will demonstrate changes in physiological characteristics of pain. 2) Changes following the mindfulness based program will be mediated by change in pain catastrophizing, self regulation capacity and pain acceptance. 3) The investigators hypothesize that gender, baseline mindfulness, and anxiety sensitivity will moderate the efficacy of the mindfulness based program.

Method: A randomized controlled design will be used to evaluate the efficacy of mindfulness based intervention on pain perception and quality of life in individuals suffering from chronic recurrent low back pain and osteoarthritis. Participants will be randomized to a mindfulness based treatment group, or to a waitlist control group, and will be assessed for psychological variables and psychophysical pain assessment before treatment. Participants allocated to treatment group will then attend six group meetings in which they will learn and practice different mindfulness meditation techniques, and will be asked to practice these techniques on a daily basis. Post treatment assessments will take place at the end of the intervention for both treatment and control groups.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

67

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Izrael
      • Beer-Sheva, Izrael
        • Clalit Health Service

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

24 lata do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  1. Patients who suffer from recurrent chronic low back pain
  2. Patients who suffer from osteoarthritis pains.
  3. The pain has to be persistent for 3 months or longer and at least moderate in severity.

Exclusion Criteria:

  1. mental illness with psychotic features
  2. cognitive impairment
  3. a history of an inpatient admission for psychiatric disorder within the past two years
  4. diagnosis of a life threatening medical condition (e.g., cancer)
  5. patients who are planning to start using other types of alternative interventions parallel to the Mindfulness Program.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Intervention group
The intervention group will participate in the Mindfulness Program consists of one 2-hour session each week for 6 consecutive weeks plus a half day retreat near the end of the intervention.
Behawioralne: mindfulness group meetings with psychologist
The Mindfulness Program consists of one 2-hour session each week for 6 consecutive weeks plus a half day retreat near the end of the intervention. Participants will attend weekly group meetings (15-20 individuals per group) in which they will be guided through a progressive experiential exploration of mindfulness. Participants will be asked to develop a daily meditation practice of 30-45 minutes with audio-recordings for guidance, and will report the amount and type of practice in a daily dairy. . A psychologist with rich personal experience in mindfulness who is trained in mindfulness based therapy will be responsible for administering the program.
Brak interwencji: Control group
Participants in the control group will be assigned to a waiting list group. Participants will be told that they will be eligible for the intervention three months after the completion of a preliminary documentation of their symptoms and additional measures. Participants will complete the same battery of measures according to the same time table as participants in the intervention group.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
change in Brief Pain Inventory Short Form questionnaire (BPI-sf)
Ramy czasowe: Administration will take place upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
measures and characterize pain and the interference of pain with the patient's life (reactive dimension). The BPI questionnaire includes a 0-10 rating scale to measure the pain and the influence of pain on different aspects of daily life (general activity, mood, sleep, relationship with other people, work) that constitute the life impact index
Administration will take place upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Brief Symptom Inventory (BSI)
Ramy czasowe: upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
53 items and provides nine sub-scale scores measuring a range of psychological symptoms and somatic complaints. Participants rate on a scale of 0 ('not at all') to 4 ('extremely') how much they were bothered in the last 7 days by each of 18 symptoms, including separate scores for anxiety, depression, somatization, and a global symptom severity index
upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
SF-12 Quality of life
Ramy czasowe: upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
The Short-Form General Health Survey is a shorter form of the widely used SF-36 and assesses health-related quality of life. It consists of 12 items that allow the calculation of 'physical health' (PCS-12) and 'mental health' (MCS-12) summary scales.
upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
Psychophysical measures
Ramy czasowe: at the entry into the study, and after 6 weeks
Using the The Thermal Sensory Analyzer we will measure Heat/ Cold pain threshold (HPT/CPT)and Supra threshold pain.
at the entry into the study, and after 6 weeks
The Pain Catastrophizing Scale
Ramy czasowe: upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
Sullivan, Bishop, & Pivik, 1995) This questionnaire includes 13 items representing the three components of pain catastrophizing: rumination (e.g., "I can't seem to keep it out of my mind"); magnification (e.g., "I wonder whether something serious may happen"); and helplessness (e.g., "There is nothing I can do to reduce the intensity of pain").
upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
Difficulties in Emotion Regulation Scale (DERS)
Ramy czasowe: upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
consists of 36 self-report items which comprise six subscales that investigate individuals' complaints about emotional regulation problems. The scales are: Non-acceptance of Emotional Response, Difficulties engaging in Goal-Directed Behavior, Impulse Control Difficulties, Lack of Emotional Awareness, limited access to Emotion Regulation Strategies and Lack of Emotional Clarity. Respondents are asked to rate their self-perceptions regarding each item on a 5-point Likert scale, which ranges from "almost never" to "almost always."
upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
The Chronic Pain Acceptance Questionnaire (CPAQ)
Ramy czasowe: upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
a 20-item, two factor (Activity Engagement and Pain Willingness) questionnaire, adapted through the process of factor analysis from the original, longer version (Geiser, 1992).
upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
Anxiety Sensitivity Index (ASI)
Ramy czasowe: at the entry into the study, and after 6 weeks
a 16-item measure on which respondents indicate, on a 5-point Likert-type scale (0=very little to 4=very much), the degree to which they fear the potential negative consequences of anxiety-related symptoms and sensations. The ASI is made up of one higher-order factor (ASI total score) and three lower-order factors: Physical, Psychological, and Social Concerns
at the entry into the study, and after 6 weeks
Mindful Attention Awareness Scale (MAAS)
Ramy czasowe: at the entry into the study, and after 6 weeks
a 15 item measure of mindfulness. The item content was design to reflect the opposite of the construct of mindfulness, or: "mindlessness" and thus endorsing the item content at a lower frequency is taken to represent a higher level of mindfulness.
at the entry into the study, and after 6 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Meir Medical Center

Śledczy

  • Główny śledczy: Pesach Shvartzman, M.D, Clalit Health Service

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 listopada 2012

Zakończenie podstawowe (Rzeczywisty)

1 lutego 2014

Ukończenie studiów (Rzeczywisty)

1 lutego 2014

Daty rejestracji na studia

Pierwszy przesłany

26 lipca 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 sierpnia 2011

Pierwszy wysłany (Oszacować)

2 sierpnia 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

30 czerwca 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 czerwca 2015

Ostatnia weryfikacja

1 czerwca 2012

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • MMC11114119KCTIL

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na mindfulness group meetings with psychologist

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