- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01866670
Effect of the Nursing Intervention "Spiritual Support"
Effect of the Nursing Intervention "Spiritual Support" in the Level of Spirituality and Clinical Parameters in Women With Breast Cancer: a Randomized Clinical Trial
Condition: patients with breast cancer. Intervention: spiritual support (relaxation + image guided + meditation) or relaxation in three consecutive meetings (day 2, 3 and 4), three days of intervention in the same week. The first day the participants will be evaluated if she meets the needs of the research and will answer questions about their indentification and spirituality.
Type of study: intervention Study design: randomized controlled trial Masking: blind study. Randomization: sequence generated by SPSS (Statistical Package for the Social Sciences) version 15, organized in sealed envelopes by another qualified professional.
The research ends in 2014 jun.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
People who attend the study sessions will participate in sessions of relaxation or of spiritual support depending on the group in which they were selected.
One way to see if there was influence of these activities for the person is measuring some factors such as heart rate, oxygen saturation and blood pressure. The interventions will be conducted by the researcher and the data will be collected by a research assistant.
Before being accepted to participate in the study each participant will be evaluated if he/she meets the needs of the research (day 1); thus it will be observed if she has or not no physical condition to perform normal activities of daily life (Eastern Cooperative Oncology Group - ECOG/Scale Zubrod) like this and your cognitive ability ((Mini-Mental State Examination MMSE/Brucki et al. 2003); if the patient is performing another type of complementary therapy will be considered his/her temporary interruption during the study period (Sheet inclusion and monitoring).
After this assessment, women who can participate in the research will answer questions about their identification (Identification Card of the study participants). They will answer five questions about spirituality (Pinto; Pais-Ribeiro, 2007).On the day 2, 3 and 4, during relaxation or spiritual support,the study participants should allow being recorded heart rate, oxygen saturation and blood pressure (ANOVA); this will be done by means of a sensor (or electrode) as those used for ECG and results will appear on a monitor (monitor BM5).
The sessions of relaxation or of spiritual support will be scheduled in three consecutive meetings in the same week, during the activities of the Teaching, Research and Rehabilitation Center for Mastectomized Women (REMA) of the University of São Paulo at Ribeirão Preto College of Nursing (EERP-USP).
The questionnaires also will be made at the end of the study (day 4), after sessions of relaxation or spiritual support to see if there was any change in the two stages and between the two groups (ANOVA). At the end they will give a score from 0 to 10, or give their opinion on the experience of the meetings (Experience Rating Scale).
Women who are selected to the sessions of relaxation may perform the activity of spiritual support in future schedules, if they want. It is necessary to participate of the selected activity, i.e., relaxation or spiritual support, and they cannot switch groups during the research.
The research ends in 2014 jun.
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
SP
-
Ribeirão Preto, SP, Brasil, 14040902
- Rekruttering
- REMA - Center for Education, Research and Rehabilitation assistence mastectomy
-
Ta kontakt med:
- Ana Maria Almeida, PhD
- Telefonnummer: 055(16)3602-3432
- E-post: amalmeid@eerp.usp.br
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Diagnosis of breast cancer (record of inclusion and monitoring);
- Patients in follow up treatment for breast cancer (record of inclusion and monitoring);
- Have more than 18 years (record of inclusion and monitoring);
Exclusion Criteria:
- Present history of psychiatric disorders involving hallucinations (record of inclusion and monitoring).
- Present energy-reduction (Eastern Cooperative Oncology Group - ECOG/Zubrod Scale) - ECOG greater than 3
- Present decreased cognition (Mini-Mental State Examination MMSE/Brucki et al. 2003) - lower sum related to grade school.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: spiritual support
-Spiritual Support: deep breathing + guided image + meditation Each patient will participate individually in three sequential meetings (A1, A2 and A3). In the experimental group, it will be developed the support spiritual intervention in all three meetings. In all meetings, namely A1, A2 and A3 the physiological parameters will be recorded (PA, SpO2, HR) through the monitor BM5. |
-Spiritual Support: deep breathing + guided image + meditation
|
Aktiv komparator: relaxation therapy
Relaxation Therapy Each patient will participate individually in three sequential meetings (A1, A2 and A3). In the control group, it will be performed just relaxing in all three meetings. In all meetings, namely A1, A2 and A3 the physiological parameters will be recorded (PA, SpO2, HR) through the monitor BM5. |
Relaxation Therapy: deep breathing
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
spirituality
Tidsramme: Spirituality Scale of Pinto and Pais-Ribeiro assessed at up to 1 week
|
After this assessment, women who can participate in the research will answer questions about their identification (Identification Card of the study participants).
They will answer five questions about spirituality (Pinto; Pais-Ribeiro, 2007); these questions also will be made at the end of the study, after sessions of relaxation or spiritual support to see if there was any change in the two stages and between the two groups (ANOVA).
At the end they will give a score from 0 to 10, or give their opinion on the experience of the meetings (Experience Rating Scale).
During relaxation or spiritual support, the study participants should allow being recorded heart rate, oxygen saturation and blood pressure (ANOVA); this will be done by means of a sensor (or electrode) as those used for ECG and results will appear on a monitor (monitor BM5).
|
Spirituality Scale of Pinto and Pais-Ribeiro assessed at up to 1 week
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 00896312.0.0000.5393
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Brystneoplasmer
-
Guangzhou First People's HospitalFullført
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital og andre samarbeidspartnereFullførtThe Clinical Application Guide of Conebeam Breast CTKina
-
Novartis PharmaceuticalsFullførtMetastatisk brystkreft (MBC) | Locally Advance Breast Cancer (LABC)Storbritannia, Spania
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkjentHR-positiv, HER2-negativ og PIK3CA Mutation Advanced Breast CancerKina
-
Rabin Medical CenterFullførtDesmoid fibromatose | Desmoid | Desmoid fibromatose i huden | Desmoid Neoplasm of Chest Wall | Desmoid-svulst forårsaket av somatisk mutasjon | Aggressive fibromatoser | Fibromatose DesmoidIsrael
-
Emory UniversityNational Cancer Institute (NCI)TilbaketrukketPrognostisk stadium IV brystkreft AJCC v8 | Metastatisk malign neoplasma i hjernen | Metastatisk brystkarsinom | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeAnatomisk stadium IV brystkreft AJCC v8 | Prognostisk stadium IV brystkreft AJCC v8 | Metastatisk malign neoplasma i beinet | Metastatisk malign neoplasma i lymfeknutene | Metastatisk malign neoplasma i leveren | Metastatisk brystkarsinom | Metastatisk malign neoplasma i lungen | Metastatisk malign neoplasma... og andre forholdForente stater, Canada, Saudi-Arabia, Korea, Republikken
Kliniske studier på spiritual support
-
Indiana UniversityIndiana University HealthFullførtMetastatisk kreft | Avansert kreftForente stater
-
Mercy Health OhioSt. Elizabeth Youngstown HospitalFullført
-
Universidade Federal do Triangulo MineiroRekruttering
-
University of California, Los AngelesAll India Institute of Medical Sciences, New Delhi; University of California... og andre samarbeidspartnereFullført
-
US Department of Veterans AffairsFullført
-
Shared Decision Making ResourcesEMD Serono; Multiple Sclerosis Association of AmericaFullførtMultippel skleroseForente stater
-
University Health Network, TorontoHumber River HospitalAktiv, ikke rekrutterende
-
The Hospital for Sick ChildrenEnduring Hearts; University of Alberta/Stollery Children's HospitalFullført
-
IMSS Hospital General de Zona 4, Celaya, Guanajauto...Fondo de Investigación en Salud (FIS), MéxicoFullførtKomplikasjoner ved keisersnittMexico
-
University College, LondonFullførtDepresjon | Angst | Ensomhet | Angstlidelse | Lavt humørStorbritannia