Fibromyalgia (FM) OR Fibromyalgia Syndrome
Conditions
Keywords
Fibromyalgia, Reiki
Brief 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 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.
Interventions
OTHERReiki Intervention
Participants assigned to this arm will receive Reiki therapy through hand imposition for 30 minutes, once weekly for 4 weeks.
OTHERSham Reiki Intervention
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.
Sponsors
Federal University of the Valleys of Jequitinhonha and Mucuri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* Clinically unstable medical condition. * Presence of acute injuries. * Pregnancy. * Cognitive impairment or any other condition that prevents the participant from completing the study questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Intensity After 4 Weeks | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Depressive Symptoms After 4 Weeks | Baseline and 4 weeks | Depressive symptoms will be assessed using the Beck Depression Inventory (BDI). Higher scores indicate greater severity of depressive symptoms. Change from baseline to the end of the 4-week intervention period will be evaluated. |
| Change From Baseline in Anxiety Symptoms After 4 Weeks | Baseline and 4 weeks | Anxiety symptoms will be assessed using the Beck Anxiety Inventory (BAI). Higher scores indicating greater severity of anxiety symptoms. Change from baseline to the end of the 4-week intervention period will be evaluated. |
| Change From Baseline in Sleep Quality After 4 Weeks | Baseline and 4 weeks | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicating poorer sleep quality. Change from baseline to the end of the 4-week intervention period will be evaluated. |
| Acute Change in Pain Intensity Following Intervention Sessions | Immediately before and immediately after each of the four weekly 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. |
| Acute Change in Heart Rate Following Intervention Sessions | Immediately before and immediately after each of the four weekly 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. |
| Acute Change in Respiratory Rate Following Intervention Sessions | Immediately before and immediately after each of the four weekly 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. |
Countries
Brazil
Contacts
CONTACTSueli F Fonseca
PRINCIPAL_INVESTIGATORRicardo A Silva
Federal University of the Valleys of Jequitinhonha and Mucuri
STUDY_DIRECTORSueli F Fonseca
Federal University of the Valleys of Jequitinhonha and Mucuri
Outcome results
None listed