Clinical trial NCT06195462: Effects of Laying on of Hands in Fibromyalgia
Official title: Effects of Laying on of Hands on Women With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: laying on of hands
therapeutic touch
pain
c
Lead sponsor: Universidade Federal do Triangulo Mineiro
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial, triple blind
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Pain Intensity at 10 weeks
timeFrame: The results were obtained at baseline, eight and 10 weeks
measure: Change from Baseline Fatigue at 10 weeks
timeFrame: The results were obtained at baseline, eight and 10 weeks
Secondary outcomes:
measure: Change from Baseline Anxiety at 10 weeks
timeFrame: The results were obtained at baseline, eight and 10 weeks
measure: Change from Baseline Stress at 10 weeks
timeFrame: The results were obtained at baseline, eight and 10 weeks
measure: Change from Baseline Depressive Symptons at 10 weeks
timeFrame: The results were obtained at baseline, eight and 10 weeks
measure: Change from Baseline Impact of Fibromyalgia at 10 weeks
timeFrame: The results were obtained at baseline, eight and 10 weeks
measure: Change from Baseline Qualities of Sleep at 10 weeks
timeFrame: The results were obtained at baseline, eight and 10 weeks
measure: Change from Baseline Qualities of Life at 10 weeks
timeFrame: The results were obtained at baseline, eight and 10 weeks
measure: Change from Baseline Safety at 10 weeks
timeFrame: The results were obtained at baseline, eight and 10 weeks
Other outcomes:
Locations:
city: Uberaba
country: Brazil
facility: Universidade Federal do triângulo Mineiro
state: Minas Gerais
Study officials:
References: