Effects of Laying on of Hands in Fibromyalgia

Effects of Laying on of Hands on Women With Fibromyalgia

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.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Laying on of hands with intention health (LHHI); Other: Laying on of hands by spiritist passe; Other: Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Uberaba, Minas Gerais, Brazil, 38025-440
      • Recruiting
      • Universidade Federal do Triangulo Mineiro
      • Contact: Élida Carneiro, PhD; Phone Number: 5534997735988; Email: elidamc16@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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.	Other: 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.; Other Names: LHHI
Experimental: 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.	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.; Other Names: Spiritist passe
Other: 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.	Other: Control; The participants will receive systemic acupuncture and they not receive the laying on of hands.; Other Names: Without laying on of hands

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Anxiety at 10 weeks	Assessment of the anxiety by depression anxiety and stress scale composed of 21 items, Each 7 items assess the presence of symptoms of depression, anxiety and stress. Whether higher scores mean a better outcome.	The results were obtained at baseline, eight and 10 weeks
Change from Baseline Stress at 10 weeks	Assessment of the stress by depression anxiety and stress scale composed of 21 items. Each 7 items assess the presence of symptoms of depression, anxiety and stress. Whether higher scores mean a better outcome.	The results were obtained at baseline, eight and 10 weeks
Change from Baseline Depressive Symptons at 10 weeks	Depression symptons will be measured by depression anxiety and stress scale composed of 21 items. Each 7 items assess the presence of symptoms of depression, anxiety and stress. Whether higher scores mean a better outcome.	The results were obtained at baseline, eight and 10 weeks
Change from Baseline Impact of Fibromyalgia at 10 weeks	Assessment of the anxiety by depression anxiety and stress scale composed of 21 items. Each 7 items assess the presence of symptoms of depression, anxiety and stress. Whether higher scores mean a better outcome.	The results were obtained at baseline, eight and 10 weeks
Change from Baseline Qualities of Sleep at 10 weeks	Assessment of the qualities of sleep by Pittsburgh instrument consists of 19 self-report questions. The sum of the values assigned to the seven components varies from zero to twenty-one in the total score of the questionnaire, indicating that the higher the number, the worse the sleep quality. Whether higher scores mean a better outcome.	The results were obtained at baseline, eight and 10 weeks
Change from Baseline Qualities of Life at 10 weeks	Assessment of the qualities of life by will be through the multi-attribute questionnaire that combines psychometric characteristics with the ability to generate utility and cost-utility indices. Whether higher scores mean a better outcome	The results were obtained at baseline, eight and 10 weeks
Change from Baseline Safety at 10 weeks	Assessment of the safety will be by presence of adverse events and vital signs	The results were obtained at baseline, eight and 10 weeks

Collaborators and Investigators

• Sponsor: Universidade Federal do Triangulo Mineiro

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Actual): January 2, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Estimated): January 8, 2024

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: pain; laying on of hands; therapeutic touch; c
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: UFTMineiro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No