FibromyalgiaNCT06195462
Effects of Laying on of Hands in Fibromyalgia
A study testing Laying on of hands with intention health (LHHI) and Laying on of hands by spiritist passe in people with Fibromyalgia, run by Universidade Federal do Triangulo Mineiro at 1 site in Brazil.
Trial summary
Fibromyalgia is conceptualized as non-inflammatory syndrome with manifestation in the musculoskeletal system associated with chronic generalized pain, fatigue, mood and sleep changes. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Laying on of hands with intention health (LHHI) and Laying on of hands by spiritist passe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 6 May 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with fibromyalgia
- up to 18 years
- diagnosis of fibromyalgia according to ACR 2010 criteria
Who cannot join
- pregnant women
- treatment for cancer
- inability to understand the questionnaires
- refusing to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal do triângulo Mineiro
Uberaba, Minas Gerais, 38025-440
Élida Carneiro, PhD, 5534997735988, elidamc16@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Laying on of hands with intention health (LHHI), Laying on of hands by spiritist passe, Control
- Keywords
- laying on of hands, therapeutic touch, pain, c
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laying on of hands with intention health (LHHI)Other
Also called 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.
Laying on of hands by spiritist passeOther
Also called 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.
ControlOther
Also called Without laying on of hands
The participants will receive systemic acupuncture and they not receive the laying on of hands.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: The results were obtained at baseline, eight and 10 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: The results were obtained at baseline, eight and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start6 May 2022
- Primary completion2 Jan 2024
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial, triple blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Triangulo Mineiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elida Mara Carneiro da Silva, Universidade Federal do Triangulo Mineiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195462
- Sponsor's protocol ID
- UFTMineiro
- Status last verified
- Jan 2024
- First submitted
- 11 May 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Laying on of Hands on Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06195462
- Acronym / sponsor ID
- UFTMineiro
- Conditions
- Fibromyalgia
- Keywords
- laying on of hands, therapeutic touch, pain, c
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universidade Federal do Triangulo MineiroUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized clinical trial, triple blind
| Arm | Type | Receives |
|---|---|---|
| Laying on of hands with healing intent (LHHI) | Sham comparator | Other: Laying on of hands with intention health (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. |
| Laying on of hands by spiritist "passe" | Experimental | Other: Laying on of hands by spiritist passeThe 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. |
| Without laying on of hands | Other | Other: ControlThe 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women with fibromyalgia
- up to 18 years
- diagnosis of fibromyalgia according to ACR 2010 criteria
Key exclusion criteria (4 listed)
- pregnant women
- treatment for cancer
- inability to understand the questionnaires
- refusing to sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laying on of hands with intention health (LHHI)Also: LHHIThe 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 | Laying on of hands with healing intent (LHHI) |
| Laying on of hands by spiritist passeAlso: Spiritist passeThe 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 | Laying on of hands by spiritist "passe" |
| ControlAlso: Without laying on of handsThe participants will receive systemic acupuncture and they not receive the laying on of hands. | Other | Without laying on of hands |
Primary outcome
Change from Baseline Pain Intensity at 10 weeks
Time frame: The results were obtained at baseline, eight and 10 weeks
Pain intensity will be evaluated by the Visual Analog Scale, whether higher scores mean a better outcome
Change from Baseline Fatigue at 10 weeks
Time frame: The results were obtained at baseline, eight and 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
7 secondary outcomes
Change from Baseline Anxiety at 10 weeks
Time frame: The results were obtained at baseline, eight and 10 weeks
Change from Baseline Stress at 10 weeks
Time frame: The results were obtained at baseline, eight and 10 weeks
Change from Baseline Depressive Symptons at 10 weeks
Time frame: The results were obtained at baseline, eight and 10 weeks
Change from Baseline Impact of Fibromyalgia at 10 weeks
Time frame: The results were obtained at baseline, eight and 10 weeks
Change from Baseline Qualities of Sleep at 10 weeks
Time frame: The results were obtained at baseline, eight and 10 weeks
Change from Baseline Qualities of Life at 10 weeks
Time frame: The results were obtained at baseline, eight and 10 weeks
Change from Baseline Safety at 10 weeks
Time frame: The results were obtained at baseline, eight and 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laying on of hands with intention health (LHHI) and Laying on of hands by spiritist passe in people with Fibromyalgia, run by Universidade Federal do Triangulo Mineiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Pain Intensity at 10 weeks (time frame: The results were obtained at baseline, eight and 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.