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NCT Number: NCT07821034

Effects of Reiki Therapy 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?

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.

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Key information

Conditions

Fibromyalgia (FM) OR Fibromyalgia Syndrome Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, 39100000, Brazil

Location status: Recruiting

Location contact

Sueli F Fonseca

CONTACT

[email protected]

55 38991802656

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reiki Intervention

Other

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

Sham Reiki Intervention

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change From Baseline in Depressive Symptoms After 4 Weeks

    Time frame: 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.

  2. Change From Baseline in Anxiety Symptoms After 4 Weeks

    Time frame: 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.

  3. Change From Baseline in Sleep Quality After 4 Weeks

    Time frame: 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.

  4. Acute Change in Pain Intensity Following Intervention Sessions

    Time frame: 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.

  5. Acute Change in Heart Rate Following Intervention Sessions

    Time frame: 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.

  6. Acute Change in Respiratory Rate Following Intervention Sessions

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sueli F Fonseca

CONTACT

[email protected]

55 38991802656

Sponsors and collaborators

Lead sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri

Other

Registry information

Official study title

Effects of Reiki Therapy on Biopsychological Outcomes in Women With Fibromyalgia: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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