Effects of Reiki Therapy in Women With Fibromyalgia

NCT07821034 | Recruiting

• 1 other identifier: UFVJM_REIKI_FM_2026
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia (FM) OR Fibromyalgia Syndrome

Keywords

Fibromyalgia; Reiki

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 4 weeks

Secondary Outcomes (6)

• Change From Baseline in Depressive Symptoms After 4 Weeks

  Baseline and 4 weeks

• Change From Baseline in Anxiety Symptoms After 4 Weeks

  Baseline and 4 weeks

• Change From Baseline in Sleep Quality After 4 Weeks

  Baseline and 4 weeks

• Acute Change in Pain Intensity Following Intervention Sessions

  Immediately before and immediately after each of the four weekly intervention sessions

• Acute Change in Heart Rate Following Intervention Sessions

  Immediately before and immediately after each of the four weekly intervention sessions

Study Arms (2)

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

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.

Other: Reiki Intervention

Interventions

Reiki Intervention OTHER

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

Reiki Therapy Group

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.

Sham Reiki Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Clinically unstable medical condition.
• Presence of acute injuries.
• Pregnancy.
• Cognitive impairment or any other condition that prevents the participant from completing the study questionnaires.

Sponsors & Collaborators

• Federal University of the Valleys of Jequitinhonha and Mucuri: lead

Study Sites (1)

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, 39100000, Brazil

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Ricardo A Silva

  Federal University of the Valleys of Jequitinhonha and Mucuri

  PRINCIPAL INVESTIGATOR

• Sueli F Fonseca

  Federal University of the Valleys of Jequitinhonha and Mucuri

  STUDY DIRECTOR

Central Study Contacts

Sueli F Fonseca

CONTACT

55 38991802656; sueli.fonseca@ufvjm.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: September 18, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)