RBR-4wtq84v Auriculotherapy and laserpuncture in the treatment of gestational nausea and vomiting

Date of registration: 01/13/2022 ^(mm/dd/yyyy)
Last approval date : 01/13/2022 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code:

• Public title:

  en

  Auriculotherapy and laserpuncture in the treatment of gestational nausea and vomiting

  pt-br

  Auriculoterapia e laserpuntura no tratamento da náusea e vômito gestacional

• Scientific acronym:

• Public acronym:

  en

  LASER

  pt-br

  LASER

• Secondaries identifiers:
  • 4.582.739
    Issuing authority: Este ECR é o Subprojeto 2a contido na aprovação do CEP

Sponsors

• Primary sponsor: Universidade Estadual de Londrina
• Secondary sponsor:
  • Institution: Universidade Estadual de Londrina
• Supporting source:
  • Institution: Universidade Estadual de Londrina

Health conditions

• Health conditions:

  en

  Study performed with pregnant women who report pregnancy-related nausea and vomiting in the first trimester of pregnancy. Auriculotherapy and laser puncture will be applied to treat these symptoms.

  pt-br

  Estudo realizado com gestantes que relatam náuseas e vômitos relacionados a gestação, no primeiro trimestre de gravidez. Será aplicado a auriculoterapia e laserpuntura para o tratamento destes sintomas.

• General descriptors for health conditions:

• Specific descriptors:

  en

  D055097 Auriculotherapy

  pt-br

  D055097 Auriculoterapia

Interventions

• Interventions:

  en

  Participants will be allocated into one of four groups: treated (semi-permanent needle and low-power laser), placebo (cotton microspheres), and control. There is no identification in DeCS for semi-permanent needle or cotton microspheres.

  pt-br

  As participantes serão alocadas em um dos quatro grupos: tratados (agulha semipermanente, e laser de baixa potência), placebo (microesferas de algodão), e controle. Não há no DeCS identificação para agulha semipermanente ou microesferas de algodão.

• Descriptors:

  en

  D055097 Auriculoterapia

  pt-br

  D055097 Auriculotherapy

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 01/10/2022 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  100	F	18 Y	0

• Inclusion criteria:

  en

  Pregnant women referred to the AEHU from prenatal care at usual risk will be included, and pregnant women at usual risk attended at UBS in the city of Londrina-PR, with a chronological age above 18 years; gestational age between 5 and 16 weeks proven by USG, regardless of parity, who report symptoms of nausea and/or vomiting as mild (PUQUE score <6) or moderate (PUQUE score between 7 and 11).

  pt-br

  Serão incluídas gestantes encaminhadas ao AEHU provenientes do pré-natal de risco habitual, e gestantes de risco habitual atendidas nas UBS da rede do município de Londrina-PR, com idade cronológica superior a 18 anos; idade gestacional entre 5 e 16 semanas comprovadas pela USG, independente da paridade, que relatem os sintomas de náusea e/ou vômito de grau leve (Escore PUQUE <6) ou moderado (Escore PUQUE entre 7 e 11).

• Exclusion criteria:

  en

  Pregnant women with diagnosed mental retardation and suicidal idealization will be excluded; coagulation disorders; in pharmacological treatment for psychosomatic illness such as anxiety and depression; hyperthyroidism; dermatological lesion in the pinna; unexplained fever; multiple pregnancy; gestational trophoblastic disease, hyperemesis gravidarum; use of antiemetic; diarrhea; pregnant women with fetuses with Down syndrome, and pregnant women afraid to receive the semi-permanent needle.

  pt-br

  Serão excluídas gestantes com deficiência mental diagnosticada e idealização suicida; distúrbios de coagulação; em tratamento farmacológico por doença psicossomática como ansiedade e depressão; hipertireoidismo; lesão dermatológica no pavilhão auricular; febre inexplicável; gestação múltipla; doença trofoblástica gestacional, hiperêmese gravídica; uso de antiemético; diarreia; gestantes com fetos portadores da síndrome de Down, e gestantes com receio de receber a agulha semipermanente.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Factorial	4	Double-blind	Randomized-controlled	1

Outcomes

• Primary outcomes:

  en

  The primary outcome is the reduction in nausea and vomiting during pregnancy, assessed using the Pregnancy Score Unique Quantification of Emesis (PUQE) instrument, a Likert scale with 5 options, answering 3 basic questions related to gestational nausea and vomiting. It will also be evaluated by reactivity to palpation at the points, classified as Grade I (the participant verbally reports the pain), II (the participant expresses pain through the face), and III (the participant tries to prevent the examination by removing the head or bringing your hand to the examiner's hand). The secondary outcome is the quality of life of pregnant women with gestational nausea and vomiting, verified through the instrument Health-Related Quality of Life Questionnaire for Nausea and Vomiting of Pregnancy (NVPQOL) – translated and validated version in Portuguese.

  pt-br

  O desfecho primário é a redução das náuseas e vômitos na gestação, avaliada por meio do instrumento Escore de Pregnancy Unique Quantification of Emesis (PUQE), uma escala likert com 5 opções, respondendo a 3 perguntas básicas referentes às náuseas e vômitos gestacionais. Será avaliado também pela reatividade à palpação auricular, classificada em Grau I (a participante refere verbalmente a dor), II (a participante expressa a dor por meio da face), e III (a paarticipante tenta impedir o exame retirando a cabeça ou levando sua mão até a mão do examinador). O desfecho secundário é a qualidade de vida das gestantes com náusea e vômitos gestacionais, verificado por meio do instrumento Health-Related Quality of Life Questionnaire for Nausea and Vomiting of Pregnancy (NVPQOL) – versão traduzida e validada em português.

• Secondary outcomes:

Contacts

• Public contact
  • Full name: Thelma Malagutti Sodre
  • • Address: Av. Robert Koch, 60
    • City: Londrina / Brazil
    • Zip code:
  • Phone: 5543998092222
  • Email: thelmalagutti@gmail.com
  • Affiliation:
   
• Scientific contact
  • Full name: Lais Oliva
  • • Address: Av. Robert Koch, 60
    • City: Londrina / Brazil
    • Zip code:
  • Phone: 5543991354469
  • Email: lais-97@hotmail.com
  • Affiliation:
   
• Site contact
  • Full name: Marcela Yasmin Ferreira Santos
  • • Address: Av. Robert Koch, 60
    • City: Londrina / Brazil
    • Zip code:
  • Phone: 5519999310877
  • Email: marcelayferreira@gmail.com
  • Affiliation:
   

Additional links:

• Download in ICTRP format