Self-management Program in Chronic Pelvic Pain
3. marts 2020 opdateret af: Marie Carmen Valenza, Universidad de Granada
Self-management Intervention for Women With Chronic Pelvic Pain: a Randomized Controlled Trial
Chronic pelvic pain is a serious health condition with an estimated prevalence of 15% women worldwide.Treatment is a challenge given the different pain generators described.
It is important to develop self-management interventions to reduce the frustration associated with its management.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Chronic pelvic pain is defined as non-cyclic pain lasting for 6 or more months, that localizes to the anatomic pelvis, anterior abdominal wall at or below the umbilicus, the lumbosacral back, or the buttocks and is of sufficient severity to cause functional disability or lead to medical care.
It can occur continuously or intermittently, with intensity severe enough to limit activities of daily living.
It is frequent in women.
The primary aim of this study isto evaluate the efficacy of a self-management intervention, as compared with an educational booklet in improving health-related quality of life and coping strategies, occupational performance, activity level and psycho-emotional symptoms in women with chronic pelvic pain.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
44
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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Granada, Spanien, 18071
- Department of Physical Therapy
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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
Kvinde
Beskrivelse
Inclusion Criteria:
- Diagnosis of chronic pelvic pain with at least 6 months of evolution
Exclusion Criteria:
- Active urogenital infection
- Pregnancy
- Cancer
- Dementia
- A surgical intervention involving lumbo-pelvic region over the past year
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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Experimental group
Patients will be included in a self-management intervention.
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Self-management intervention will include presentation and discussion of various topics regarding chronic pain mechanisms and pain self-monitoring.
The intervention will also incorporate a task-oriented approach focused on relevant activities in order to acquire coping skills.
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Ingen indgriben: Control group
Patients will receive a booklet with information.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Perceived health-related quality of life
Tidsramme: Change from baseline health-related quality of life at 7 weeks
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Health-related quality of life will be assessed using the EuroQol-5D.
This scale consists of a descriptive system and the EQ visual analogue scale.
The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, oain/discomfort and anxiety/depression.
Each dimension has 3 levels: no problems, some problems, extreme problems.
Higher scores indicate more problems.
In the visual analogue scale the patient rate the pain from 100 (best imaginable health state) to 0 (worst imaginable health state).
Higher values represent a better health state.
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Change from baseline health-related quality of life at 7 weeks
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Change in coping strategies
Tidsramme: Change from baseline coping strategies at 7 weeks
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Coping strategies will be evaluated using the Coping Strategies Questionnaire (CSQ).
It assesses eight different coping strategies for pain which describe two types of coping: adaptive coping (diverting Attention, coping self-statements, ignoring sensations, reinterpreting pain sensation, hoping and cognitive distracting) and maladaptive coping (catastrophizing, and faithing and praying).
Participants score each item using a 7-point scale to indicate how often they use that strategy to manage their pain (0 never, 3 sometimes, and 6 always)
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Change from baseline coping strategies at 7 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in performance of activities
Tidsramme: Change from baseline self-perceived performance at 7 weeks
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Canadian Occupational Performance Measure will be used to evaluate changes in patient's self-perception over time including performance and satisfaction scored from 0 to 10. Higher values represented improvement on perceived performance and satisfaction
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Change from baseline self-perceived performance at 7 weeks
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Change in activity levels
Tidsramme: Change from baseline self-reported activity levels at 7 weeks
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Activity levels will be evaluated with the International Physical Activity Questionnaire.
It assess the frequency and time spent on vigorous, moderate-intensity activities and walking time for each category.
Higher values indicate higher activity levels.
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Change from baseline self-reported activity levels at 7 weeks
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Change in anxiety levels.
Tidsramme: Change from baseline anxious symptoms at 7 weeks
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Anxiety will be evaluated using the Beck Anxiety Inventory.
It contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely).
Higher total scores indicate more severe anxiety symptoms.
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Change from baseline anxious symptoms at 7 weeks
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Change in depressive symptoms
Tidsramme: Change from baseline depressive symptoms at 7 weeks
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Depression will be evaluated using the Beck Depression Inventory.
It contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely).
Higher total scores indicate severe depressive symptoms.
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Change from baseline depressive symptoms at 7 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
23. juli 2018
Primær færdiggørelse (Faktiske)
21. oktober 2018
Studieafslutning (Faktiske)
29. april 2019
Datoer for studieregistrering
Først indsendt
31. juli 2018
Først indsendt, der opfyldte QC-kriterier
31. juli 2018
Først opslået (Faktiske)
6. august 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. marts 2020
Sidst verificeret
1. marts 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DF00800UG
Plan for individuelle deltagerdata (IPD)
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