Anxiety DisordersREFLEX-ANSNCT07161102
Effect of Foot Reflexology on Anxiety
A study testing Reflexology in people with Anxiety Disorders, run by Carlos Germano Dias Santos at 1 site in Brazil.
Trial summary
This randomized, sham-controlled, parallel, double-blind clinical trial investigates the effects of foot reflexology on anxiety and well-being in adults with anxiety disorders. Participants are randomized (1:1) to receive either standardized foot reflexology or sham massage for 10 sessions (twice per week, 5 weeks). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Reflexology
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jul 2025to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 60 years.
- Clinical diagnosis of anxiety disorder confirmed by a healthcare professional (physician or psychologist).
- Score ≥ 11 on the Beck Anxiety Inventory (BAI) in the initial assessment.
- Availability to participate in the 10 proposed sessions.
- Signed informed consent.
Who cannot join
- Current use of benzodiazepines, antidepressants, or other psychotropic medications initiated less than 3 months ago.
- Associated diagnosis of psychotic disorder, bipolar disorder, or active suicidal ideation.
- Presence of serious or decompensated medical conditions (e.g., severe cardiovascular disease, uncontrolled epilepsy).
- Simultaneous participation in other complementary therapies (e.g., acupuncture, auriculotherapy, yoga, Reiki) during the study period.
- Pregnant or lactating women.
- Individuals with foot injuries, infections, or diseases that prevent foot reflexology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Centro Universitário Mauricio de Nassau
Vitória da Conquista, Estado de Bahia, 45005338
About this study
Official title: The Use of Foot Reflexology in Alleviating Anxiety Symptoms: A Randomized Clinical Trial
This randomized, sham-controlled, parallel, double-blind clinical trial investigates the effects of foot reflexology on anxiety and well-being in adults with anxiety disorders. Participants are randomized (1:1) to receive either standardized foot reflexology or sham massage for 10 sessions (twice per week, 5 weeks). The primary outcome is the change in Beck Anxiety Inventory (BAI) score from baseline to the 10th session. Secondary outcomes include BAI score at 30-day follow-up, relaxation and well-being assessed immediately after each session with the Profile of Mood States (POMS - Brazilian version, Tension-Anxiety subscale), and incidence of adverse events. It is hypothesized that foot reflexology will result in a greater reduction of anxiety symptoms compared to sham massage.
Read the detailed description
Participants aged 18-60 years with a clinical diagnosis of anxiety (DSM-5) are recruited and randomized 1:1 into two groups:
Experimental: standardized foot reflexology protocol targeting reflex points (solar plexus, CNS, pituitary, heart, diaphragm).
Sham comparator: foot manipulation and mobilization (sliding, flexion-extension, rotation, traction) without stimulation of reflex points.
Both interventions last approximately 15 minutes per session, 10 sessions total (twice per week for 5 weeks).
Assessments:
BAI at baseline, after 5 sessions, after 10 sessions, and 30-day follow-up. POMS (Tension-Anxiety subscale) immediately after each session (sessions 1-10). Checklist for adverse events (e.g., redness, pain, tingling, transient discomfort).
Blinding: Participants, care providers, outcome assessors, and statisticians are blinded to group allocation.
- Conditions
- Anxiety Disorders
- Being tested
- Reflexology, Sham Reflexology
- Keywords
- Anxiety, Reflexology, Foot Reflexology, Complementary Therapies, Integrative Health, POMS, BAI, Sham Massage
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyOther
A complementary technique that involves applying pressure to reflexology points on the feet. In this study, foot reflexology will be applied in 10 sessions, twice a week, for 30 minutes, aiming to reduce anxiety symptoms.
Sham ReflexologyOther
A simulated procedure consisting of superficial and random maneuvers on the feet, without stimulation of specific reflexology points. Ten sessions will be conducted twice a week, each lasting 30 minutes, for placebo control purposes.
| Study group | Role | What they receive |
|---|---|---|
| Foot Reflexology | Experimental | Participants will receive 10 foot reflexology sessions, administered twice a week, each lasting approximately 30 minutes. The technique will be performed on specific reflexology points on the feet, according to protocols described in the scientific literature, aiming to reduce anxiety symptoms. Receives: Other: Reflexology |
| Sham Reflexology | Sham comparator | Participants will receive 10 simulated intervention sessions, administered twice a week, each lasting approximately 30 minutes. The technique will consist of light, superficial touches to the feet, without stimulating reflexology points, with the aim of simulating the intervention without specific therapeutic effects. Receives: Other: Sham Reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Anxiety Symptoms (BAI)
Anxiety symptom variation was assessed using the Beck Anxiety Inventory (BAI), a validated and widely used scale for measuring the intensity of anxiety symptoms. The total score ranges from 0 to 63, with higher scores indicating greater anxiety. The analysis will compare the scores obtained in the first session (baseline), the fifth session, and the tenth intervention session.
Measured: Baseline, after 5 sessions and after 10 sessions (approximately 5 weeks).
Secondary outcomes (2)
Reduction of tension-anxiety levels (Profile of Mood States - POMS, reduced version)
Assessment of subjective perception of relaxation and psychological well-being using the Tension-Anxiety subscale of the Profile of Mood States (POMS) - Reduced Version, validated for Portuguese. Scores range from 0 to 36, with higher scores indicating greater tension and anxiety and lower scores indicating greater relaxation and well-being.
Measured: Baseline, after 5 sessions (approximately 2.5 weeks), and after 10 sessions (approximately 5 weeks).
Recording of adverse effects related to the intervention
Systematic monitoring and recording of any adverse effects reported during or after foot reflexology or sham reflexology sessions, including pain, discomfort, or unexpected reactions. Outcomes will be categorized by frequency (number of participants affected) and intensity (mild, moderate, severe).
Measured: Throughout the intervention period (10 sessions - approximately 5 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start30 Jul 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion5 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carlos Germano Dias Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carlos Germano Dias Santos, Centro Universitário Maurício de Nassau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161102
- Sponsor's protocol ID
- UNINASSAU-REFLEXO-GERMANO-2025
- Acronym
- REFLEX-ANS
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Foot Reflexology in Alleviating Anxiety Symptoms: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07161102
- Acronym / sponsor ID
- REFLEX-ANS / UNINASSAU-REFLEXO-GERMANO-2025
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety, Reflexology, Foot Reflexology, Complementary Therapies, Integrative Health, POMS, BAI, Sham Massage
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Carlos Germano Dias SantosUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 5 Dec 2025 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, sham-controlled, parallel, double-blind clinical trial investigates the effects of foot reflexology on anxiety and well-being in adults with anxiety disorders. Participants are randomized (1:1) to receive either standardized foot reflexology or sham massage for 10 sessions (twice per week, 5 weeks). The primary outcome is the change in Beck Anxiety Inventory (BAI) score from baseline to the 10th session. Secondary outcomes include BAI score at 30-day follow-up, relaxation and well-being assessed immediately after each session with the Profile of Mood States (POMS - Brazilian version, Tension-Anxiety subscale), and incidence of adverse events. It is hypothesized that foot reflexology will result in a greater reduction of anxiety symptoms compared to sham massage.
Detailed description
Participants aged 18-60 years with a clinical diagnosis of anxiety (DSM-5) are recruited and randomized 1:1 into two groups:
Experimental: standardized foot reflexology protocol targeting reflex points (solar plexus, CNS, pituitary, heart, diaphragm).
Sham comparator: foot manipulation and mobilization (sliding, flexion-extension, rotation, traction) without stimulation of reflex points.
Both interventions last approximately 15 minutes per session, 10 sessions total (twice per week for 5 weeks).
Assessments:
BAI at baseline, after 5 sessions, after 10 sessions, and 30-day follow-up. POMS (Tension-Anxiety subscale) immediately after each session (sessions 1-10). Checklist for adverse events (e.g., redness, pain, tingling, transient discomfort).
Blinding: Participants, care providers, outcome assessors, and statisticians are blinded to group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foot Reflexology | Experimental | Other: ReflexologyParticipants will receive 10 foot reflexology sessions, administered twice a week, each lasting approximately 30 minutes. The technique will be performed on specific reflexology points on the feet, according to protocols described in the scientific literature, aiming to reduce anxiety symptoms. |
| Sham Reflexology | Sham comparator | Other: Sham ReflexologyParticipants will receive 10 simulated intervention sessions, administered twice a week, each lasting approximately 30 minutes. The technique will consist of light, superficial touches to the feet, without stimulating reflexology points, with the aim of simulating the intervention without specific therapeutic effects. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 60 years.
- Clinical diagnosis of anxiety disorder confirmed by a healthcare professional (physician or psychologist).
- Score ≥ 11 on the Beck Anxiety Inventory (BAI) in the initial assessment.
- Availability to participate in the 10 proposed sessions.
- Signed informed consent.
Key exclusion criteria (6 listed)
- Current use of benzodiazepines, antidepressants, or other psychotropic medications initiated less than 3 months ago.
- Associated diagnosis of psychotic disorder, bipolar disorder, or active suicidal ideation.
- Presence of serious or decompensated medical conditions (e.g., severe cardiovascular disease, uncontrolled epilepsy).
- Simultaneous participation in other complementary therapies (e.g., acupuncture, auriculotherapy, yoga, Reiki) during the study period.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReflexologyA complementary technique that involves applying pressure to reflexology points on the feet. In this study, foot reflexology will be applied in 10 sessions, twice a week, for 30 minutes, aiming to reduce anxiety symptoms. | Other | Foot Reflexology |
| Sham ReflexologyA simulated procedure consisting of superficial and random maneuvers on the feet, without stimulation of specific reflexology points. Ten sessions will be conducted twice a week, each lasting 30 minutes, for placebo control purposes. | Other | Sham Reflexology |
Primary outcome
Reduction of Anxiety Symptoms (BAI)
Time frame: Baseline, after 5 sessions and after 10 sessions (approximately 5 weeks).
Anxiety symptom variation was assessed using the Beck Anxiety Inventory (BAI), a validated and widely used scale for measuring the intensity of anxiety symptoms. The total score ranges from 0 to 63, with higher scores indicating greater anxiety. The analysis will compare the scores obtained in the first session (baseline), the fifth session, and the tenth intervention session.
2 secondary outcomes
Reduction of tension-anxiety levels (Profile of Mood States - POMS, reduced version)
Time frame: Baseline, after 5 sessions (approximately 2.5 weeks), and after 10 sessions (approximately 5 weeks).
Recording of adverse effects related to the intervention
Time frame: Throughout the intervention period (10 sessions - approximately 5 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology in people with Anxiety Disorders, run by Carlos Germano Dias Santos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Anxiety Symptoms (BAI) (time frame: Baseline, after 5 sessions and after 10 sessions (approximately 5 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.