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Effect of Spiritist "Passe" Energy Therapy in Reducing Anxiety in Volunteers

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ClinicalTrials.gov Identifier: NCT02376959
Recruitment Status : Unknown
Verified February 2015 by Associação Médico Espírita de Botucatu.
Recruitment status was:  Recruiting
First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Associação Médico Espírita de Botucatu

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).

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: Spiritist "passe" Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Spiritist "Passe" Energy Therapy in Reducing Anxiety in Volunteers
Study Start Date : September 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Placebo Comparator: Control Group
Application of 8 spiritist "passe" simulation sessions by people without spiritist training at the same time and in the same environment as the treatment group.
Active Comparator: Treatment Group (Spiritist "passe")
Application 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.
Behavioral: Spiritist "passe"

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.





Primary Outcome Measures :
  1. Change in Anxiety questionnaire from baselaine at 8 weeks [ Time Frame: Baselaine; 4 weeks and 8 weeks ]

Secondary Outcome Measures :
  1. Change in Beck Depression Inventory from baselaine at 8 weeks [ Time Frame: Baselaine; 4 weeks and 8 weeks ]
  2. Change in WHOQOL-BREF quality of life questionnaire from baselaine at 8 weeks [ Time Frame: Baselaine; 4 weeks and 8 weeks ]
  3. Change in DUREL questionnaire for assessment of spirituality from baselaine at 8 weeks [ Time Frame: Baselaine; 4 weeks and 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age greater ≥18 years
  2. Score of STAI-Trait questionnaire >41 (corresponding to the 51% for the Brazilian population)

Exclusion Criteria:

  1. Patients with cognitive impairment who are unable to understand the questionnaires
  2. Patients undergoing treatment for anxiety or depression
  3. Patients undergoing psychological counseling
  4. Patients receiving psychiatric care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376959


Contacts
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Contact: Luis Gustavo M Andrade, Dr. 55 14 3814-2574 landrade@fmb.unesp.br
Contact: Vanessa B Banin, Dr. 55 14 3811-6005 vanessa_banin@yahoo.com.br

Locations
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Brazil
Botucatu Medical School Recruiting
Botucatu, Sao Paulo, Brazil, 18618970
Contact: Luis Gustavo M Andrade, Dr.    55 14 3811-6547    landrade@fmb.unesp.br   
Sponsors and Collaborators
Associação Médico Espírita de Botucatu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Associação Médico Espírita de Botucatu
ClinicalTrials.gov Identifier: NCT02376959    
Other Study ID Numbers: 31078414.5.0000.5411
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015
Keywords provided by Associação Médico Espírita de Botucatu:
Anxiety
Complementary Therapies
energy therapies
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders