Effects of Laying on of Hands in Fibromyalgia

NCT ID: NCT06195462

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-06
• Study Completion Date: 2024-06-30

Brief Summary

Fibromyalgia is conceptualized as non-inflammatory syndrome with manifestation in the musculoskeletal system associated with chronic generalized pain, fatigue, mood and sleep changes. Laying on of hands therapies are intended to prevent injuries, promote health recovery and harmony between the physical, mental and spiritual dimensions. The aim of this study is to evaluate the effects of laying on of hands with and without a spiritual connection on the mental and physical health, well-being and quality of life of women with fibromyalgia. 72 patients will be divided into 3 groups: control - without imposition of hands, imposition without spiritual presence with the intention of healing and imposition with spiritual presence through the spiritist passe.

Detailed Description

This is a triple-blind, randomized, controlled clinical trial of 10 weeks, with a minimum sample of 72 participants, to be carried out at the Center for Integrative and Complementary Practices of the Hospital de Clínicas da UFTM. Participants will be informed about the research objectives, their voluntary participation and anonymity. Then, they will be randomly placed in one of the groups: control, imposition by volunteers with healing intent (GIM) and spiritist passe. All participants will lie on a stretcher for about 5 minutes, then vital signs (blood pressure and heart rate and pain assessment by VAS) will be measured before, immediately after the intervention on days D1, D8 and D10. During the laying on of hands, they will receive the following verbal command: "Mentalize relief of pain and improvement of symptoms". After the end of the intervention, they will receive systemic acupuncture: the acupuncture application method will be standardized in all participants, insertion of a systemic needle 0.20 x 0.40 perpendicularly in the following points: pericardium 6, heart 7, spleen, pancreas 6, large intestine 4, liver 2, stomach 36 bilaterally and will remain for about 20 minutes. Participants will receive interventions lying on stretchers in a room prepared for this purpose. The eyes will be blindfolded with a visor made for the study.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Laying on of hands with healing intent (LHHI)

The non-healers volunteers will move their hands in a longitudinal direction, starting at the top of the patient's head, slowly lowering their hands along the body, 5 times and asked to send thoughts of health and healing to the participant. Then, they will place their hands on the patient's head, distance about 10 to 15 cm, during 5 minutes. Weekly sessions.

Group Type: SHAM_COMPARATOR

Laying on of hands with intention health (LHHI)

Intervention Type: OTHER

The participants will receive systemic acupuncture. The no healers will move their hands in a longitudinal direction, starting at the top of the patient's head, slowly lowering their hands along the body, 5 times and asked to send thoughts of health and healing to the participant. Then, they will place their hands on the patient's head, distance about 10 to 15 cm, during 5 minutes. Weekly sessions.

Laying on of hands by spiritist "passe"

The healers will prepare before the start with prayer for connection with Good Spirits. Volunteers will move their hands in a longitudinal direction, starting at the top of the patient's head, slowly lowering their hands along the body, 5 times and asked to send thoughts of health and healing to the participant. Then, they will place their hands on the patient's head, distance about 10 to 15 cm, during 5 minutes. Weekly sessions.

Group Type: EXPERIMENTAL

Laying on of hands by spiritist passe

Intervention Type: OTHER

The participants will receive systemic acupuncture. The healers will prepare before the start with prayer for connection with Good Spirits and will move their hands in a longitudinal direction, starting at the top of the patient's head, slowly lowering their hands along the body, 5 times and asked to send thoughts of health and healing to the participant. Then, they will place their hands on the patient's head, distance about 10 to 15 cm, during 5 minutes. Weekly sessions.

Without laying on of hands

The participants will not receive the laying on of hands. A volunteer will stand next to the patient with hands behind them and will mentally repeat the alphabet or do math for 5 minutes. Weekly sessions.

Group Type: OTHER

Control

Intervention Type: OTHER

The participants will receive systemic acupuncture and they not receive the laying on of hands.

Interventions

Laying on of hands with intention health (LHHI)

The participants will receive systemic acupuncture. The no healers will move their hands in a longitudinal direction, starting at the top of the patient's head, slowly lowering their hands along the body, 5 times and asked to send thoughts of health and healing to the participant. Then, they will place their hands on the patient's head, distance about 10 to 15 cm, during 5 minutes. Weekly sessions.

Intervention Type: OTHER

Laying on of hands by spiritist passe

The participants will receive systemic acupuncture. The healers will prepare before the start with prayer for connection with Good Spirits and will move their hands in a longitudinal direction, starting at the top of the patient's head, slowly lowering their hands along the body, 5 times and asked to send thoughts of health and healing to the participant. Then, they will place their hands on the patient's head, distance about 10 to 15 cm, during 5 minutes. Weekly sessions.

Intervention Type: OTHER

Control

The participants will receive systemic acupuncture and they not receive the laying on of hands.

Intervention Type: OTHER

Other Intervention Names

LHHI; Spiritist passe; Without laying on of hands

Eligibility Criteria

Inclusion Criteria

• women with fibromyalgia
• up to 18 years
• diagnosis of fibromyalgia according to ACR 2010 criteria

Exclusion Criteria

• pregnant women
• treatment for cancer
• inability to understand the questionnaires
• refusing to sign the informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Triangulo Mineiro

OTHER

Sponsor Role: lead

Responsible Party

Elida Mara Carneiro da Silva

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal do triângulo Mineiro

Uberaba, Minas Gerais, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Élida Carneiro, PhD

Role: primary

elidamc16@gmail.com

5534997735988

Other Identifiers

UFTMineiro

Identifier Type: -

Identifier Source: org_study_id