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Effect of Floral Therapy on Anxiety in caregivers of elderly individuals at home

Effectiveness of Floral Therapy in the Anxiety of informal caregivers of dependent elderly individuals at home: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8v96qwb
Enrollment
Unknown
Registered
2024-05-02
Start date
2023-11-01
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

Anxiety

Interventions

Clinical Trial, Randomized, parallel, with two arms, double-blind, placebo-controlled, lasting four weeks. A total of 100 eligible individuals will be randomly assigned to either the intervention grou
E06.658.453.560

Sponsors

Faculdade de Enfermagem da Universidade Estadual de Campinas - UNICAMP
Lead Sponsor
Faculdade de Odontologia de Bauru - Universidade de São Paulo (FOB-USP)
Collaborator

Eligibility

Age
9 Years to 14 Years

Inclusion criteria

Inclusion criteria: Individuals aged between 9 and 14 years; both genders; in stages of cervical maturation Cervical Stage 2 or 3 according to the Cervical Vertebrae Maturation method, carriers of Class II division 1 malocclusion (skeletal parameter: ANB > 4); dental parameter: minimum severity of ½ Angle Class II) and diagnosed with Obstructive Sleep Apnea (OSA), screened by the validated Brazilian version of the Pediatric Sleep Questionnaire and confirmed by polysomnography (PSG)

Exclusion criteria

Exclusion criteria: Hyperdivergent individuals; those with craniofacial syndromes and anomalies; individuals who have undergone previous orthodontic treatments with headgear, jaw breakers, any type of functional orthopedic appliance and fixed appliances

Design outcomes

Primary

MeasureTime frame
It is expected to find a decrease in the Oxygen Desaturation Index (ODI) of post-treatment patients compared to the initial ODI, decreasing to final ODI < initial ODI, and, in cases of excellent results, ODI = 0.

Secondary

MeasureTime frame
It is expected that treatment with the Herbst Appliance will promote an increase in the Upper Airways (UA), assessed through Teleradiography, by cephalometric parameters described in the research project.

Countries

Brazil

Contacts

Public ContactRute;Kamila Nobre;Machado

Faculdade de Enfermagem da Universidade Estadual de Campinas - UNICAMP;Faculdade de Odontologia de Bauru - Universidade de São Paulo (FOB-USP)

rutealessandradasilvanobre@gmail.com;kmachado@usp.br+55(19)996260777;+55(71)999718149

Outcome results

None listed

Source: REBEC (via WHO ICTRP)