Data Analysis

The analysis was based on the group in which the study patients were randomized (intention- to- treat basis). The demographic data for category data, we will be reported by descriptive statistics: frequency, percentage. For continuing data, we will be used:  mean, and standard deviation. The types of preferred music will be reported by descriptive statistics for category data, we will be used: frequency and percentage.   Outcomes variables: Primary outcome, Pain score with assumes to be continuous data. We will be measured at baseline after treatment time 1 and time2. We estimated measure difference between 2 groups and its 95% CI and p-value for each time by using ANCOVA. Baseline pain will be included as covariates in analyses of   pain. Anxiety scores for continuous data. We will be measured at baseline and after treatment. We estimated measure difference between 2 groups and its 95% CI and p-value by using ANCOVA. Baseline anxiety scores will be included as covariates in analyses of anxiety. Secondary outcome: Satisfaction for using music therapy for category data will be reported by descriptive statistics, frequency and percentage.

All hypothesis tests are two-tailed test at significant level of 0.05.  All statistical analysis was implemented in Stata version 10 (Stata Corp., Tx).

Control of Bias

Selection bias: This study will be controlled by using randomization.

Information bias: The researcher will be given information to the music group about an importance of following the treatment. 

Confounding bias: will be controlled by restriction in inclusion-

exclusion criteria and randomization process to make these factors balance between two groups The potential confounding factors including analgesia will be controlled by schedule and baseline of anxiety and pain have an effect on outcome; I will be controlled by using ANCOVA. Including a covariate (Pretest: Pain and Anxiety)