Effect of Spiritist "Passe" Energy Therapy in Reducing Anxiety in Volunteers
1 other identifier
interventional
60
1 country
1
Brief Summary
Background: The use of alternative therapies in medicine has been increasing worldwide. Among these therapies are energy therapies such as Reiki , Johrei, and Spiritist "passe." Experimental studies have confirmed the action of the energy therapies in animal models or in cell cultures. These therapies appear to have positive effects, particularly in the reduction of anxiety and pain. Objective: To evaluate the effectiveness of the "passe" energy therapy in reducing anxiety in subjects presenting anxiety symptoms after 8 weeks of study. Methods: The recruited volunteers will be randomized into two groups: the Control Group (application of 8 "passe" simulation sessions by people without spiritualist training at the same time and in the same environment as the treatment group) and the Treatment Group (application of 8 sessions of "passe" by spiritists with over 2 years of experience in controlled environments for the same period as the control group). The sample will consist of 60 patients selected by interviews with the expectation of a 20% reduction of anxiety in the control group and 60% in the treatment group with alpha of 0.05 and beta of 0.8. Results: Using the STAI scale for evaluation, the reduction in anxiety is expected to be significantly higher in the treatment group than in the control group. The investigators expect approximately 20-30% reduction of the anxiety in the control group by the placebo effect. Other objectives to be assessed are quality of life, spirituality, and depression by specific standardized scales (WHOQOL-BREF, DUREL, and BECK).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 18, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 3, 2015
February 1, 2015
1.2 years
February 18, 2015
February 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Anxiety questionnaire from baselaine at 8 weeks
Baselaine; 4 weeks and 8 weeks
Secondary Outcomes (3)
Change in Beck Depression Inventory from baselaine at 8 weeks
Baselaine; 4 weeks and 8 weeks
Change in WHOQOL-BREF quality of life questionnaire from baselaine at 8 weeks
Baselaine; 4 weeks and 8 weeks
Change in DUREL questionnaire for assessment of spirituality from baselaine at 8 weeks
Baselaine; 4 weeks and 8 weeks
Study Arms (2)
Control Group
PLACEBO COMPARATORApplication of 8 spiritist "passe" simulation sessions by people without spiritist training at the same time and in the same environment as the treatment group.
Treatment Group (Spiritist "passe")
ACTIVE COMPARATORApplication of 8 sessions of spiritist "passe" by spiritists with more than 2 years of experience in controlled environments for the same period as the control group.
Interventions
For a period of 5 min per week, the volunteers will remain in the supine position with their eyes closed, in a quiet environment with controlled light and temperature. The applied intervention will consist of placing both hands in the classic Spiritist "passe" position for the stipulated 5-min period. Spiritist "passe" will be applied by volunteers with training and experience of more than two years with the technique.
Eligibility Criteria
You may qualify if:
- Age greater ≥18 years
- Score of STAI-Trait questionnaire \>41 (corresponding to the 51% for the Brazilian population)
You may not qualify if:
- Patients with cognitive impairment who are unable to understand the questionnaires
- Patients undergoing treatment for anxiety or depression
- Patients undergoing psychological counseling
- Patients receiving psychiatric care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Botucatu Medical School
Botucatu, São Paulo, 18618970, Brazil
Related Publications (1)
de Souza Cavalcante R, Banin VB, de Moura Ribeiro Paula NA, Daher SR, Habermann MC, Habermann F, Bravin AM, da Silva CE, de Andrade LG. Effect of the Spiritist "passe" energy therapy in reducing anxiety in volunteers: A randomized controlled trial. Complement Ther Med. 2016 Aug;27:18-24. doi: 10.1016/j.ctim.2016.05.002. Epub 2016 May 6.
PMID: 27515871DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2015
First Posted
March 3, 2015
Study Start
September 1, 2014
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
March 3, 2015
Record last verified: 2015-02