Effects of Laying on of Hands in Fibromyalgia

NCT06195462 | Unknown

• 1 other identifier: UFTMineiro
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

laying on of hands; therapeutic touch; pain; c

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Pain Intensity at 10 weeks

  Pain intensity will be evaluated by the Visual Analog Scale, whether higher scores mean a better outcome

  The results were obtained at baseline, eight and 10 weeks

• Change from Baseline Fatigue at 10 weeks

  Fatigue will be evaluated by fatigue pictogram, an illustrated instrument composed of two questions graded in 5 captioned illustrations that assess the intensity of fatigue, whether higher scores mean a better outcome

  The results were obtained at baseline, eight and 10 weeks

Secondary Outcomes (7)

• Change from Baseline Anxiety at 10 weeks

  The results were obtained at baseline, eight and 10 weeks

• Change from Baseline Stress at 10 weeks

  The results were obtained at baseline, eight and 10 weeks

• Change from Baseline Depressive Symptons at 10 weeks

  The results were obtained at baseline, eight and 10 weeks

• Change from Baseline Impact of Fibromyalgia at 10 weeks

  The results were obtained at baseline, eight and 10 weeks

• Change from Baseline Qualities of Sleep at 10 weeks

  The results were obtained at baseline, eight and 10 weeks

Study Arms (3)

Laying on of hands with healing intent (LHHI)

SHAM COMPARATOR

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.

Other: Laying on of hands with intention health (LHHI)

Laying on of hands by spiritist "passe"

EXPERIMENTAL

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.

Other: Laying on of hands by spiritist passe

Without laying on of hands

OTHER

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.

Other: Control

Interventions

Laying on of hands with intention health (LHHI) 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.

Also known as: LHHI

Laying on of hands with healing intent (LHHI)

Laying on of hands by spiritist passe 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.

Also known as: Spiritist passe

Laying on of hands by spiritist "passe"

Control OTHER

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

Also known as: Without laying on of hands

Without laying on of hands

Eligibility Criteria

• Age: 18 Years - 59 Years
• Gender Eligibility Details: 18 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal do Triangulo Mineiro: lead

Study Sites (1)

Universidade Federal do triângulo Mineiro

Uberaba, Minas Gerais, 38025-440, Brazil

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study, the blinding will be triple blinded because the Investigators, care provider, patients and Outcomes Assessor are unaware of which group the participants were allocated to. To ensure the blinding of the participants, their eyes will be blindfolded with a visor made for the study on a white compress.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Randomized clinical trial, triple blind

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: January 8, 2024
• Study Start: May 6, 2022
• Primary Completion: January 2, 2024
• Study Completion: June 30, 2024
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)