Effects of Reiki Therapy in Women With Fibromyalgia

Condition(s) studied

Investigational drug(s) / intervention(s)

Reiki Intervention: Participants assigned to this arm will receive Reiki therapy through hand imposition for 30 minutes, once weekly for 4 weeks.

Sham 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

More Federal University of the Valleys of Jequitinhonha and Mucuri trials in Brazil