Evaluation of the efficacy of listening to music before blood donation on anxiety: a randomized clinical trial

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-6tvbdn
• Date of registration: 19/06/2017
• Prospective Registration: Yes
• Primary sponsor: Universidade Federal do Triângulo Mineiro
• Public title: Evaluation of the efficacy of listening to music before blood donation on anxiety: a randomized clinical trial
• Scientific title: The effect of music on blood donor anxiety: a randomized clinical trial
• Date of first enrolment: 01/02/2018
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-6tvbdn
• Study type: Intervention
• Study design: Clinical trial of safety and efficacy, randomized controlled, parallel, two-arm, double-blind
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Maria Helena Barbosa
• Affiliation: Universidade Federal do Triângulo Mineiro

• Name: Maria Helena Barbosa
• Affiliation: Universidade Federal do Triângulo Mineiro

Key inclusion & exclusion criteria

Inclusion criteria: Blood donors;
Exclusion criteria: Blood donors who have a deficit or hearing problems; who are classified as sporadic donors (donor repeating donation after more than 12 months of the last donation); who are using anxiolytic medications.

Age minimum: 18Y
Age maximum: 60Y
Gender: -

Health Condition(s) or Problem(s) studied

F01.470.132

Anxiety

Intervention(s)

Experimental Group (n = 63): Participants were invited to stay in a private room where identification data were collected, followed by the application of the instrument to measure anxiety scores and the evaluation of physiological parameters (10 minutes). Subsequently, they received the headset connected to the MP3 player for listening to an instrumental music session for 26 minutes. Immediately at the end of the intervention, anxiety scores and physiological parameters were again evaluated (10 minutes) and participants were referred to the collection room. At the time of the collection of blood typing and serology samples, a blood sample was collected for the measurement of blood cortisol.

Control Group (n = 63): Participants were invited to stay in a private room where identification data were collected, followed by the application of the instrument to measure anxiety scores and the evaluation of physiological parameters (10 minutes). Later, they followed the usual flow of donation. Anxiety scores and physiological parameters were again evaluated (10 minutes) and participants were referred to the collection room. At the time of the collection of blood typing and serology samples, a blood sample was collected for the measurement of blood cortisol.

Behavioural

F04.754.137

Primary Outcome(s)

Reduction of anxiety scores. Score below
30 measured by IDATE - Inventory of State- Trait Anxiety

Secondary Outcome(s)

Decreased cortisol levels. The reference values vary according to the time of day that the blood is collected (between 7 and 9 hours: 5.4 to 25.0 ?g/dL, between 16 and 17 hours: 2.4 to 13.6 ?g/dL).

Source(s) of Monetary Support

Universidade Federal do Triângulo Mineiro

Fundação Centro de Hematologia e Hemoterapia de Minas Gerais (Hemominas)

Secondary Sponsor(s)

Fundação Centro de Hematologia e Hemoterapia de Minas Gerais (Hemominas)