RBR-7pzb4sw The effects of flower essence therapies on people with alcohol withdrawal

Date of registration: 08/07/2023 ^(mm/dd/yyyy)
Last approval date : 08/07/2023 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1284-5485

• Public title:

  en

  The effects of flower essence therapies on people with alcohol withdrawal

  pt-br

  Os efeitos das terapias de florais em pessoas com abstinência do álcool

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 61762022.1.0000.5537
    Issuing authority: Plataforma Brasil
  • 5.723.500
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal do Rio Grande do Norte

Sponsors

• Primary sponsor: Universidade Federal do Rio Grande do Norte
• Secondary sponsor:
  • Institution: Universidade Federal do Rio Grande do Norte
• Supporting source:
  • Institution: Universidade Federal do Rio Grande do Norte

Health conditions

• Health conditions:

  en

  Alcohol Abstinence

  pt-br

  Abstinência de Álcool

• General descriptors for health conditions:

  en

  F01 Behavior and Behavioral Mechanisms

  pt-br

  F01 Comportamento e Mecanismos Comportamentais

• Specific descriptors:

  en

  F01.145.317.134 Alcohol Abstinence

  pt-br

  F01.145.317.134 Abstinência de Álcool

Interventions

• Interventions:

  en

  At first, users who meet the criteria will be invited to participate and will be informed about all ethical and logistical precepts of the research, such as objectives and interventions, in addition to reading and signing the Free and Informed Consent Term (TCLE) in acceptance case. In a second moment, a researcher will carry out the first application of the collection instruments. Soon after, the individuals will be randomized according to the stratum through the website www.randomization.com. In a third moment, the administration of interventions will be carried out. The Control Group (CG) will receive only orally filtered water in 21 ml flasks as a placebo, due to its lack of smell, color and odor similar to the intervention group. The Flower Remedies Group (GF) will be aimed at users who will receive Bach Flower Remedies therapy orally as an intervention. Rescue remedy was chosen for 10 consecutive days. In the masking process, the team that will carry out the assisted administration of the floral remedies and the participants will not know who is in the control group or the floral group, configuring themselves as double-blind. During the five days, two measurements will be made regarding the level of SAA, state and trait anxiety and craving. In a second moment, a researcher will carry out the first application of the collection instruments. Soon after, the individuals will be randomized according to the stratum through the website www.randomization.com. In a third moment, the administration of interventions will be carried out. The Control Group (CG) will receive only orally filtered water in 21 ml flasks as a placebo, due to its lack of smell, color and odor similar to the intervention group. The Flower Remedies Group (RG) will be aimed at users who will receive Bach Flower Remedies therapy orally as an intervention. Rescue remedy was chosen for 10 consecutive days. In the masking process, the team that will carry out the assisted administration of the floral remedies and the participants will not know who is in the control group or the floral group, configuring themselves as double-blind. During the ten days, three measurements will be made regarding the level of AWS, state and trait anxiety and craving. These measurements will be performed on the 3rd, 5th and 10th after the first moment.

  pt-br

  No primeiro momento, os usuários que atenderem aos critérios serão convidados a participar e serão informados sobre todos os preceitos éticos e logísticos da pesquisa, tais como os objetivos e intervenções, além da leitura e assinatura do Termo de Consentimento Livre e Esclarecido (TCLE) em caso de aceite. Em um segundo momento, um pesquisador realizará a primeira aplicação dos instrumentos de coleta. Logo após, será feita à randomização dos indivíduos conforme o estrato por meio do website www.randomization.com. Em um terceiro momento será realizada a administração das intervenções. O Grupo controle (GC) receberá apenas água filtrada via oral em frascos de 21 ml como placebo, devido não possuir cheiro, cor e odor semelhante ao grupo de intervenção. O Grupo dos Florais (GF) se destinará aos usuários que irão receber a terapia dos Florais de Bach por via oral como intervenção. Optou-se pelo rescue remedy durante 10 dias consecutivos. No processo de mascaramento, a equipe que realizará a administração assistida dos florais e os participantes não saberão quem é do grupo controle ou do grupo de florais, se configurando como duplo-cego. Durante os cinco dias serão feitas duas mensurações quanto ao nível da SAA, da ansiedade de estado e traço e do craving.

• Descriptors:

  en

  D20.215.784.500.087 Flower Essences

  pt-br

  D20.215.784.500.087 Essências Florais

  en

  MT3.685.759 Floral Therapy

  pt-br

  MT3.685.759 Terapia Floral

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 09/01/2023 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  52	-	18 Y	60 Y

• Inclusion criteria:

  en

  Female and male users, have a diagnosis of disorder related to alcohol abuse, be 18 years old or older, have been admitted to CAPS AD III, have an up-to-date Single Therapeutic Project (PTS), have been previously diagnosed with Down Syndrome Mild/moderate alcohol abstinence and being in overnight care (24-hour monitoring) for the first time.

  pt-br

  Usuários do sexo feminino e masculino, ter o diagnóstico de transtorno relacionado ao abuso de álcool, possuir 18 anos ou mais, ter sido acolhido no CAPS AD III, possuir um Projeto Terapêutico Singular (PTS) atualizado, ter sido diagnosticado previamente com a Síndrome da Abstinência Alcoólica leve/moderada e estar em acolhimento noturno (acompanhamento 24 horas) pela primeira vez.

• Exclusion criteria:

  en

  Users who make use of multiple drugs, who have a previous allergy to any component of the Bach Flower Remedies, who for some reason have evaded the service, or any situation that interrupts continued follow-up (evasion or transfer to another device in the healthcare network). health).

  pt-br

  Usuários que façam uso de múltiplas drogas, que possua alergia prévia a algum componente dos Florais de Bach, que por alguma razão tenha se evadido do serviço, ou qualquer situação que interrompa o acompanhamento continuado (evasão ou transferência para outro dispositivo da rede de atenção a saúde).

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	1	Double-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  It is expected that, through the clinical trial method, the study has shown a reduction in anxiety in individuals with Alcohol Withdrawal Syndrome through the evaluation parameters of the instruments used to verify the results. It is expected that the scores vary between 38 and 42 on the Likert scales to verify if what really happened in the pre- and post-interruptions exercises, with a variation of at least 5%.

  pt-br

  Espera-se que por meio do método de ensaio clínico o estudo apresente redução da ansiedade em indivíduos com Síndrome da Abstinência Alcoólica através dos parâmetros de avaliação dos instrumentos utilizados para verificar os desfechos. Espera-se que os scores variem entre 38 e 42 nas escalas likert para verificar se o desfecho realmente aconteceu nas medições do pré e o pós- intervenções, sendo uma variação de no mínimo 5%.

  en

  It is expected that, through the randomized clinical trial, the study will show a reduction in cravings in individuals with Alcohol Withdrawal Syndrome through the evaluation parameters of the instruments used. In this sense, showing craving scores between 12 and 17 on the Likert scales to verify whether the outcome really happened in the pre- and post-intervention measurements.

  pt-br

  Espera-se que, por meio do método de ensaio clínico, o estudo mostre a redução da fissura em indivíduos com Síndrome de Abstinência Alcoólica por meio dos parâmetros de avaliação dos instrumentos utilizados. Nesse sentido, apresentar escores de craving entre 12 e 17 nas escalas Likert para verificar se o desfecho realmente aconteceu nas medidas pré e pós-intervenção, com variação de 5%.

• Secondary outcomes:

  en

  Secondary outcomes are not expected.

  pt-br

  Não são esperados desfechos secundários.

Contacts

• Public contact
  • Full name: Universidade Federal do Rio Grande do Norte
  • • Address: Campus Universitário- Lagoa Nova
    • City: Natal / Brazil
    • Zip code: 59078-970
  • Phone: +55(084)33422299
  • Email: posenfermagemufrn@gmaiil.com
  • Affiliation: Universidade Federal do Rio Grande do Norte
   
• Scientific contact
  • Full name: Universidade Federal do Rio Grande do Norte
  • • Address: Campus Universitário- Lagoa Nova
    • City: Natal / Brazil
    • Zip code: 59078-970
  • Phone: +55(084)33422299
  • Email: posenfermagemufrn@gmaiil.com
  • Affiliation: Universidade Federal do Rio Grande do Norte
   
• Site contact
  • Full name: Universidade Federal do Rio Grande do Norte
  • • Address: Campus Universitário- Lagoa Nova
    • City: Natal / Brazil
    • Zip code: 59078-970
  • Phone: +55(084)33422299
  • Email: posenfermagemufrn@gmaiil.com
  • Affiliation: Universidade Federal do Rio Grande do Norte
   

Additional links:

• Download in ICTRP format