OBJECTIVE: To test whether music by Mozart reduces anxiety among patients undergoing colposcopy. METHODS: In a randomized multicenter trial, we measured the reduction of the situation-specific anxiety of women hearing Mozart's Symphony No. 40 during colposcopy compared with women not hearing music using the State-Trait Anxiety Inventory. Secondary endpoints were reduction of heart rate (beats per minute), pain during and 10 minutes after colposcopy, general unpleasantness, anxiety during colposcopy, and overall satisfaction (11-item visual analog scales). Analysis was by intention to treat. A sample size of 104 per group (N=208) was calculated to achieve 80% power to detect a difference of 4.8 with a SD of 12.3 in anxiety scores. RESULTS:Between February 2017 and May 2018, 212 women were randomized. The mean anxiety reduction was -9.4±10.8 SD in 103 women in the music group and -9.0±10.6 in 102 women in the control group (P=.40). The secondary endpoints reduction of heart rate (-16.3±16.9 vs -15.4±17.1; P=.37), pain during procedure (median 2 [interquartile range 1-4] vs 2 [1-3.5]; P=.80), pain 10 minutes after examination (1 [0-1.75] vs 1 [0-2]; P=.42), general unpleasantness (3 [1-5.75] vs 4 [1-5.5]; P=.35), anxiety during examination (2 [1-5] vs 2 [1-6]; P=.28), and overall satisfaction (10 [9-10] vs 10 [9-10]; P=.81) were also not different between the two study groups. CONCLUSION: Mozart's Symphony No. 40 does not reduce anxiety in women undergoing colposcopy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03005795.
RCT Entities:
OBJECTIVE: To test whether music by Mozart reduces anxiety among patients undergoing colposcopy. METHODS: In a randomized multicenter trial, we measured the reduction of the situation-specific anxiety of women hearing Mozart's Symphony No. 40 during colposcopy compared with women not hearing music using the State-Trait Anxiety Inventory. Secondary endpoints were reduction of heart rate (beats per minute), pain during and 10 minutes after colposcopy, general unpleasantness, anxiety during colposcopy, and overall satisfaction (11-item visual analog scales). Analysis was by intention to treat. A sample size of 104 per group (N=208) was calculated to achieve 80% power to detect a difference of 4.8 with a SD of 12.3 in anxiety scores. RESULTS: Between February 2017 and May 2018, 212 women were randomized. The mean anxiety reduction was -9.4±10.8 SD in 103 women in the music group and -9.0±10.6 in 102 women in the control group (P=.40). The secondary endpoints reduction of heart rate (-16.3±16.9 vs -15.4±17.1; P=.37), pain during procedure (median 2 [interquartile range 1-4] vs 2 [1-3.5]; P=.80), pain 10 minutes after examination (1 [0-1.75] vs 1 [0-2]; P=.42), general unpleasantness (3 [1-5.75] vs 4 [1-5.5]; P=.35), anxiety during examination (2 [1-5] vs 2 [1-6]; P=.28), and overall satisfaction (10 [9-10] vs 10 [9-10]; P=.81) were also not different between the two study groups. CONCLUSION: Mozart's Symphony No. 40 does not reduce anxiety in women undergoing colposcopy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03005795.