Auriculotherapy to reduce pain, anxiety and improving the quality of life

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-5pc43m
• Date of registration: 19/04/2016
• Prospective Registration: No
• Primary sponsor: Escola de Enfermagem da Universidade de São Paulo
• Public title: Auriculotherapy to reduce pain, anxiety and improving the quality of life
• Scientific title: Effectiveness of auriculotherapy to reduce pain and anxiety and improving the quality of life of nursing professionals: a randomized clinical trial
• Date of first enrolment: 26/06/2015
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-5pc43m
• Study type: Intervention
• Study design: Randomized, controlled clinical trial, parallel, four-arm
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Leonice Fumiko Sato Kurebayashi
• Affiliation: Escola de Enfermagem da Universidade de São Paulo

• Name: Ruth Natalia Teresa Turrini
• Affiliation: Escola de Enfermagem da Universidade de São Paulo

Key inclusion & exclusion criteria

Inclusion criteria: The subjects of the nursing staff (auxiliaries, technicians and nurses) that present a score above 33 points according to the State-Trait Anxiety Inventory (middle and high level of anxiety) and those who have availability of time for submission to the sessions.
Exclusion criteria: Pregnant women; subjects who go on vacation or sick leave during the research period; those who begin to use allopathic medicines for anxiety and antidepressants during the period of research; those who have metal and adesive tape allergy and who initiate other complementary therapies (acupuncture, massage, herbal medicine, Reiki, Flower therapy etc.) for anxiety control during the period.

Age minimum: 18Y
Age maximum: 65Y
Gender: -

Health Condition(s) or Problem(s) studied

musculoskeletal pain, anxiety

C05.651.538

F01.470.132

Intervention(s)

31 patients will be the control group (no treatment), 35 patients will be submitted to the auricular group with seeds (10 sessions, twice a week), 34 patients will be submitted to the auricular group with semi-permanent needles (10 sessions, twice a week) and 33 patients will be submitted to the placebo group with adhesive tape (10 sessions, twice a week)

Other

E02.190.204

Primary Outcome(s)

Reduction of anxiety levels after 5 weeks of treatment. It will be used two instruments to assess anxiety levels (Trait-State Anxiety Inventory and Hamilton Inventory). For finding the expected outcome, a variation of at least 5% will be considered at each scale before and after treatment.

Secondary Outcome(s)

Pain after 5 weeks of treatment evaluated from the Analog Visual Scale. For finding the expected outcome, a variation of at least 5% will be considered at the scale before and after treatment.

Quality of Life Improvement of physical and mental aspects after 5 weeks of treatment. It will be used the quality of life instrument (SF12v2).For finding the expected outcome, a variation of at least 5% will be considered at each scale before and after treatment.

Source(s) of Monetary Support

Real e Benemérita Associação Portuguesa de Beneficência

Secondary Sponsor(s)

Leonice Fumiko Sato Kurebayashi