NCT02376959

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 3, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

February 18, 2015

Last Update Submit

February 25, 2015

Conditions

Keywords

AnxietyComplementary Therapiesenergy therapies

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 COMPARATOR

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.

Treatment Group (Spiritist "passe")

ACTIVE COMPARATOR

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"

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.

Treatment Group (Spiritist "passe")

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

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.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Luis Gustavo M Andrade, Dr.

CONTACT

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

Locations