Effects of Reiki Therapy in Women With Fibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFederal University of the Valleys of Jequitinhonha and Mucuri
About this 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?
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Reiki Intervention
Other interventionParticipants assigned to this arm will receive Reiki therapy through hand imposition for 30 minutes, once weekly for 4 weeks.
Sham Reiki Intervention
Other 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Sham Reiki GroupPlacebo comparator 1 intervention
Group B: Reiki Therapy GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 4 weeks2
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.
Time frame
Baseline and 4 weeksSecondary outcomes
1
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.
Time frame
Baseline and 4 weeks2
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.
Time frame
Baseline and 4 weeks3
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.
Time frame
Baseline and 4 weeks4
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.
Time frame
Immediately before and immediately after each of the four weekly intervention sessionsSponsors and contacts
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Source ClinicalTrials.gov