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Controlling symptoms in people with trigeminal nerve pain

Controlling symptoms in people with Trigeminal Neuralgia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-69dym8p
Enrollment
Unknown
Registered
2025-05-16
Start date
2024-09-17
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Interventions

This is a randomized, parallel, open, four-arm clinical trial. The population will consist of 50 patients registered for treatment, in which 10 to 15 participants will be allocated to each group. Part

Sponsors

Universidade Federal de Alfenas - Unifal
Lead Sponsor
Casa de Caridade Nossa Senhora do Perpétuo Socorro - Santa Casa de Alfenas
Collaborator
Prefeitura Municipal de Alfenas
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older; regardless of gender; patients with trigeminal neuralgia (TN) who have not responded to the usual clinical treatment; who have not previously undergone any surgical procedure for the treatment of TN; who are physically and cognitively able to understand the Informed Consent Form and participate in the study by answering the instruments used

Exclusion criteria

Exclusion criteria: Patients who are delirious or mentally confused at the time of the approach; patients with psychiatric symptoms (psychosis, suicidal ideation, bipolar disorder); patients with an intense pain crisis that makes it impossible to respond to the study instruments; other personal and behavioral circumstances that would limit compliance with the study requirements, or judged by the doctor in charge to be incompatible with the possibility of participating in the study

Design outcomes

Primary

MeasureTime frame
It is hoped to find an improvement in the intensity, location, sensory, affective and cognitive quality of pain, assessed using the Multidimensional Pain Assessment Scale (MDAS). The instrument aims to assess pain in its multiple dimensions, such as intensity, location, sensory, affective and cognitive quality. The scale has been validated for Portuguese and has specific descriptors for acute and chronic pain. The instrument is made up of descriptors for acute and chronic pain. The EMADOR uses psychophysical methods to quantify pain, including numerical estimates and pairing of magnitudes. It is expected that there will be a statistically significant reduction, considering a significance level with a p-value of less than 0.05 for the scale variables in relation to the groups and times.

Secondary

MeasureTime frame
We expect to see an improvement in patients' spiritual well-being after the intervention. This outcome will be assessed using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-Sp-12), an instrument made up of 12 items divided into three subscales: meaning, peace and faith. The answers are given on a five-point likert scale. The scale is self-administered, but can also be applied by interview. The total score is obtained by adding up the results of the sub-scales, so that the higher the values, the higher the level of spiritual well-being.;We expect to see an improvement in patients' religious/spiritual coping after the intervention. This outcome will be assessed using the Brief Religious/Spiritual Coping Scale. The instrument is subdivided into two subscales: Positive CRE and Negative CRE. The higher the overall score on the scale, the greater the use of religious/spiritual coping strategies.

Countries

Brazil

Contacts

Public ContactAna Cláudia Garcia

Universidade Federal de Alfenas - Unifal - MG

ana.mesquita@unifal-mg.edu.br+55 35 9277-7676

Outcome results

None listed

Source: REBEC (via WHO ICTRP)