The effect of music on the anxiety of children before surgery: a nursing intervention

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-7mcr59
• Date of registration: 31/03/2015
• Prospective Registration: No
• Primary sponsor: Distrito Federal Secretaria de Saude
• Public title: The effect of music on the anxiety of children before surgery: a nursing intervention
• Scientific title: The music listening applied to children undergoing surgery: a nursing intervention to relieve anxiety
• Date of first enrolment: 22/09/2014
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-7mcr59
• Study type: Intervention
• Study design: Controlled clinical trial focusing on treatment efficacy, randomized, parallel, single-blind, with two arms
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Mariana André Honorato Franzoi
• Affiliation: Mariana André Honorato Franzoi

• Name: Mariana André Honorato Franzoi
• Affiliation: Mariana André Honorato Franzoi

Key inclusion & exclusion criteria

Inclusion criteria: children; age 3 to 12; both genders; to be subjected to any elective surgery; who agree to participate in the study, from the signing of free and informed consent term; that has a charge which agrees the child to participate in the research, from the signing of informed consent and informed

Exclusion criteria: Children under 3 years of age and over 12 years; that will undergo emergency surgery; who have received premedication before the intervention to be tested; who have hearing problems and mental disorders; children or guardians who do not consent to take part or that are not available to participate in all stages of the study

Age minimum: 3Y
Age maximum: 12Y
Gender: -

Health Condition(s) or Problem(s) studied

J35.8

N43.4

Q10-Q18

Q54.9

Undescended testis, Hypospadias, Other congenital malformations of the urinary tract, prepuce hypertrophy, phimosis and paraphimosis, hydrocele and Spermatoceles, inguinal hernia, umbilical hernia, acute tonsillitis, tonsil diseases and unspecified adenoids, Other congenital malformations of the face and neck

Q62.7

Q53.9

Intervention(s)

Experimental group: 15 children aged 3-12 years during the preoperative period, will be submitted to hearing from randomly pre-selected instrumental music, with tempo 60-80 beats per minute, available through a device and MP3 Player a headset for 15 minutes.
Control group: 15 children aged 3-12 years during the preoperative period, will receive only the standard care in the surgical clinic for 15 minutes. But as masking strategy, after 15 minutes without receiving intervention and assessment of outcomes, the control group children also hear music, but now, without the intention to collect or evaluate data

Other

K01.602

Primary Outcome(s)

Reduction of preoperative anxiety level checked by varying vital signs such as blood pressure, heart rate, respiratory rate and oxygen saturation, by method of statistical analysis and inferential nature as measures of frequency and central tendency, test chi-square and Fisher for comparison of frequencies, from the observation of a variation of at least 5% in the pre- and post-intervention measurements

Secondary Outcome(s)

Reducing the level of preoperative verified by the pattern of variation anxiety assessed by the modified Yale Preoperative Anxiety Scale (YPAS-m) through inferential statistical analysis method such as die Wilcoxon and Mann-Whitney test for comparison of medians and percentiles of scores of YPAS-m, from the observation of a variation of at least 5% in pre and post intervention measurements

Source(s) of Monetary Support

Distrito Federal Secretaria de Saude

Secondary Sponsor(s)

Distrito Federal Secretaria de Saude