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- Klinische proef NCT03212105
A 60-seconds Personalized Mindfulness Video Exercise for Patients With Orthopedic Illness
The purpose of this study is to determine within a randomized controlled trial the feasibility of a 60-second acceptance based mindfulness exercise for patients with musculoskeletal pain versus usual medical care. Feasibility will be evaluated as the number of individuals approached who agree to participate and the number of individuals who drop out prior to completion of post intervention questionnaires.
The investigators aim to determine the usefulness and acceptability of the 60-second acceptance based mindfulness exercise for patients with musculoskeletal pain as compared to usual medical care. Usefulness and acceptability will be assessed with the Client Satisfaction Scale-3 (CSQ-3).
The investigators also aim to determine whether participating in a personalized 60-second acceptance based mindfulness exercise (e.g., intervention) is associated with significantly more improvement in patients' ratings of state anxiety and pain intensity (co-primary outcomes), and to determine if Distress, Anxiety, Depression and Anger (secondary outcomes) decrease compared to a brief educational pamphlet (e.g., control).
The investigators also aim to determine whether any improvements observed will maintain within a 3 month follow up.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- All patients presenting to Hand and Upper Extremity Service at Massachusetts General Hospital
- English fluency and literacy
Exclusion Criteria:
- Pregnant women
- Significant Axis I or II psychopathology that would interfere with participation in the study
- Age < 18 years old
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 60 Second Video
The mindfulness intervention is a video-flash found at http://www.pixelthoughts.co.
In this exercise patients are asked to write down a concern or worry, and watch it get put into perspective within a 60 seconds time frame.
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The mindfulness intervention will be a video-flash found at http://www.pixelthoughts.co.
In this exercise patients are asked to write down a concern or worry, and watch it get put into perspective within a 60 seconds time frame.
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Ander: Educational Pamphlet
The educational pamphlet contains information about pain and stress, which patients will be able to read within 60 seconds.
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The educational pamphlet will contain information about pain and stress, which patients will be able to read within 60 seconds.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Client Satisfaction Scale-3 (CSQ-3)
Tijdsspanne: Day 1 after completing 60-second intervention
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The client satisfaction scale-3 (CSQ-3) is a 3 question instrument to measure satisfaction with health and human services.
Responses are based on a 4-point scale.
The score range is from 3-12, where higher values indicate higher satisfaction.
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Day 1 after completing 60-second intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in State-Trait Anxiety Inventory (STAI)
Tijdsspanne: Before intervention, immediately after intervention, and 3 months after enrollment
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The STAI questionnaire measures trait and state anxiety.
The questionnaire has 20 items based on a 4-point scale.
A higher score is indicative of greater anxiety.
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Before intervention, immediately after intervention, and 3 months after enrollment
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Change in Pain Intensity
Tijdsspanne: Before intervention, immediately after intervention, and 3 months after enrollment
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Pain intensity as measured by ordinal rating of pain.
On a scale from 0-10, where 0 is no pain and 10 is the worst pain imagined.
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Before intervention, immediately after intervention, and 3 months after enrollment
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Change in Distress, Anxiety, Depression, and Anger
Tijdsspanne: Before intervention, immediately after intervention, and 3 months after enrollment
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A visual scale using 4 emotional thermometers to measure each distress, anxiety, depression, and anger.
The scale is from 0-10, where 0 means experience none of the emotion and 10 is extreme.
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Before intervention, immediately after intervention, and 3 months after enrollment
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 2015P002349
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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