Fibromyalgia (FM) OR Fibromyalgia SyndromeNCT07821034
Effects of Reiki Therapy in Women With Fibromyalgia
A study testing Reiki Intervention in people with Fibromyalgia (FM) OR Fibromyalgia Syndrome, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
Trial summary
The goal of this randomized clinical trial is to evaluate the effects of a 4-week Reiki therapy program in women with fibromyalgia. The main questions it aims to answer are: Does Reiki therapy lead to a greater change in pain intensity compared with a placebo intervention after 4 weeks of treatment? Does Reiki therapy… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromyalgia (FM) OR Fibromyalgia Syndrome
- What is being tested?
- Reiki Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Sep 2025to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 18 years or older.
- Medical diagnosis of fibromyalgia, confirmed according to the 2016 American College of Rheumatology (ACR) criteria using the Brazilian version of the Fibromyalgia Survey Questionnaire (FSQ-Brazil).
Who cannot join
- Clinically unstable medical condition.
- Presence of acute injuries.
- Pregnancy.
- Cognitive impairment or any other condition that prevents the participant from completing the study questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Diamantina, Minas Gerais, 39100000
Sueli F Fonseca, 55 38991802656, sueli.fonseca@ufvjm.edu.br
About this study
Official title: Effects of Reiki Therapy on Biopsychological Outcomes in Women With Fibromyalgia: A Randomized Controlled Trial
The goal of this randomized clinical trial is to evaluate the effects of a 4-week Reiki therapy program in women with fibromyalgia. The main questions it aims to answer are:
Does Reiki therapy lead to a greater change in pain intensity compared with a placebo intervention after 4 weeks of treatment?
Read more
Does Reiki therapy lead to a greater change in the impact of fibromyalgia compared with a placebo intervention after 4 weeks of treatment?
Researchers will also evaluate whether Reiki therapy affects depressive symptoms, anxiety symptoms, sleep quality, and acute changes in pain intensity, heart rate, and respiratory rate.
Researchers will compare participants receiving Reiki therapy with participants receiving a placebo intervention to determine whether changes in these outcomes differ between groups.
Participants will:
be randomly assigned to either the Reiki therapy group or the placebo group; receive one 30-minute intervention session per week for 4 weeks; complete assessments of pain intensity, fibromyalgia impact, depressive symptoms, anxiety symptoms, and sleep quality before and after the 4-week intervention period; have pain intensity, heart rate, and respiratory rate assessed immediately before and after each intervention session to evaluate acute responses.
- Being tested
- Reiki Intervention, Sham Reiki Intervention
- Keywords
- Fibromyalgia, Reiki
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki InterventionOther
Participants assigned to this arm will receive Reiki therapy through hand imposition for 30 minutes, once weekly for 4 weeks.
Sham Reiki InterventionOther
Participants assigned to this arm will be positioned under the same conditions as participants in the Reiki Intervention Group and will remain in the intervention setting for 30 minutes; however, no hand imposition or Reiki intervention will be administered. Sessions will occur once weekly for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sham Reiki Group | Placebo comparator | Participants assigned to this arm will be positioned under the same conditions as participants in the Reiki Intervention Group and will remain in the intervention setting for 30 minutes; however, no hand imposition or Reiki intervention will be administered. Sessions will occur once weekly for 4 weeks Receives: Other: Sham Reiki Intervention |
| Reiki Therapy Group | Experimental | Participants assigned to this arm will receive a 30-minute Reiki intervention through hand imposition, once weekly for 4 weeks. Receives: Other: Reiki Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Intensity After 4 Weeks
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their current pain intensity on a scale ranging from 0 to 10, with higher scores indicating greater pain intensity. Change from baseline to the end of the 4-week intervention period will be evaluated.
Measured: Baseline and 4 weeks
Change From Baseline in Fibromyalgia Impact After 4 Week
The impact of fibromyalgia will be assessed using the Revised Fibromyalgia Impact Questionnaire (FIQR). The total score ranges from 0 to 100, with higher scores indicating greater impact of fibromyalgia on health and daily functioning. Change from baseline to the end of the 4-week intervention period will be evaluated.
Measured: Baseline and 4 weeks
Secondary outcomes (6)
Change From Baseline in Depressive Symptoms After 4 Weeks
Depressive symptoms will be assessed using the Beck Depression Inventory. The total score ranges from 0 to 63, with higher scores indicating greater severity of depressive symptoms. Change from baseline to the end of the 4-week intervention period will be evaluated.
Measured: Baseline and 4 weeks
Change From Baseline in Anxiety Symptoms After 4 Weeks
Anxiety symptoms will be assessed using the Beck Anxiety Inventory. The total score ranges from 0 to 63, with higher scores indicating greater severity of anxiety symptoms. Change from baseline to the end of the 4-week intervention period will be evaluated.
Measured: Baseline and 4 weeks
Change From Baseline in Sleep Quality After 4 Weeks
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Change from baseline to the end of the 4-week intervention period will be evaluated.
Measured: Baseline and 4 weeks
Acute Change in Pain Intensity Following Intervention Sessions
Pain intensity will be assessed using the Visual Analog Scale (VAS) immediately before and immediately after each intervention session. Scores range from 0 to 10, with higher scores indicating greater pain intensity. Acute pre-to-post-session changes will be evaluated across the four weekly sessions.
Measured: Immediately before and immediately after each of the four weekly intervention sessions
Acute Change in Heart Rate Following Intervention Sessions
Heart rate will be measured in beats per minute immediately before and immediately after each intervention session. Acute pre-to-post-session changes will be evaluated across the four weekly sessions.
Measured: Immediately before and immediately after each of the four weekly intervention sessions
Acute Change in Respiratory Rate Following Intervention Sessions
Respiratory rate will be measured in breaths per minute immediately before and immediately after each intervention session. Acute pre-to-post-session changes will be evaluated across the four weekly sessions.
Measured: Immediately before and immediately after each of the four weekly intervention sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start18 Sep 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM) OR Fibromyalgia SyndromeStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo A Silva, Principal investigator, Federal University of the Valleys of Jequitinhonha and MucuriSueli F Fonseca, Study director, Federal University of the Valleys of Jequitinhonha and Mucuri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821034
- Sponsor's protocol ID
- UFVJM_REIKI_FM_2026
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reiki Therapy on Biopsychological Outcomes in Women With Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07821034
- Acronym / sponsor ID
- UFVJM_REIKI_FM_2026
- Keywords
- Fibromyalgia, Reiki
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 15 Sep 2026 (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.
The goal of this randomized clinical trial is to evaluate the effects of a 4-week Reiki therapy program in women with fibromyalgia. The main questions it aims to answer are:
Does Reiki therapy lead to a greater change in pain intensity compared with a placebo intervention after 4 weeks of treatment?
Does Reiki therapy lead to a greater change in the impact of fibromyalgia compared with a placebo intervention after 4 weeks of treatment?
Researchers will also evaluate whether Reiki therapy affects depressive symptoms, anxiety symptoms, sleep quality, and acute changes in pain intensity, heart rate, and respiratory rate.
Researchers will compare participants receiving Reiki therapy with participants receiving a placebo intervention to determine whether changes in these outcomes differ between groups.
Participants will:
be randomly assigned to either the Reiki therapy group or the placebo group; receive one 30-minute intervention session per week for 4 weeks; complete assessments of pain intensity, fibromyalgia impact, depressive symptoms, anxiety symptoms, and sleep quality before and after the 4-week intervention period; have pain intensity, heart rate, and respiratory rate assessed immediately before and after each intervention session to evaluate acute responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Reiki Group | Placebo comparator | Other: Sham Reiki InterventionParticipants assigned to this arm will be positioned under the same conditions as participants in the Reiki Intervention Group and will remain in the intervention setting for 30 minutes; however, no hand imposition or Reiki intervention will be administered. Sessions will occur once weekly for 4 weeks |
| Reiki Therapy Group | Experimental | Other: Reiki InterventionParticipants assigned to this arm will receive a 30-minute Reiki intervention through hand imposition, once weekly for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female participants aged 18 years or older.
- Medical diagnosis of fibromyalgia, confirmed according to the 2016 American College of Rheumatology (ACR) criteria using the Brazilian version of the Fibromyalgia Survey Questionnaire (FSQ-Brazil).
Key exclusion criteria (4 listed)
- Clinically unstable medical condition.
- Presence of acute injuries.
- Pregnancy.
- Cognitive impairment or any other condition that prevents the participant from completing the study questionnaires.
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 |
|---|---|---|
| Reiki InterventionParticipants assigned to this arm will receive Reiki therapy through hand imposition for 30 minutes, once weekly for 4 weeks. | Other | Reiki Therapy Group |
| Sham Reiki InterventionParticipants assigned to this arm will be positioned under the same conditions as participants in the Reiki Intervention Group and will remain in the intervention setting for 30 minutes; however, no hand imposition or Reiki intervention will be administered. Sessions will occur once weekly for 4 weeks. | Other | Sham Reiki Group |
Primary outcome
Change From Baseline in Pain Intensity After 4 Weeks
Time frame: Baseline and 4 weeks
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their current pain intensity on a scale ranging from 0 to 10, with higher scores indicating greater pain intensity. Change from baseline to the end of the 4-week intervention period will be evaluated.
Change From Baseline in Fibromyalgia Impact After 4 Week
Time frame: Baseline and 4 weeks
The impact of fibromyalgia will be assessed using the Revised Fibromyalgia Impact Questionnaire (FIQR). The total score ranges from 0 to 100, with higher scores indicating greater impact of fibromyalgia on health and daily functioning. Change from baseline to the end of the 4-week intervention period will be evaluated.
6 secondary outcomes
Change From Baseline in Depressive Symptoms After 4 Weeks
Time frame: Baseline and 4 weeks
Change From Baseline in Anxiety Symptoms After 4 Weeks
Time frame: Baseline and 4 weeks
Change From Baseline in Sleep Quality After 4 Weeks
Time frame: Baseline and 4 weeks
Acute Change in Pain Intensity Following Intervention Sessions
Time frame: Immediately before and immediately after each of the four weekly intervention sessions
Acute Change in Heart Rate Following Intervention Sessions
Time frame: Immediately before and immediately after each of the four weekly intervention sessions
Acute Change in Respiratory Rate Following Intervention Sessions
Time frame: Immediately before and immediately after each of the four weekly intervention sessions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- 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.
Ricardo A Silva principal investigator
Federal University of the Valleys of Jequitinhonha and Mucuri
Sueli F Fonseca study director
Federal University of the Valleys of Jequitinhonha and Mucuri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki Intervention in people with Fibromyalgia (FM) OR Fibromyalgia Syndrome, run by Federal University of the Valleys of Jequitinhonha and Mucuri 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 2 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sueli F Fonseca (55 38991802656, sueli.fonseca@ufvjm.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pain Intensity After 4 Weeks (time frame: Baseline and 4 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 21 Sep 2026.