Preferred Music Therapy for Anxiety and Pain reduction in Cancer Patients
Design: a randomized controlled trail, experimental design
Populations: Cancer patients with pain were purposively selected for the study according to the following criteria
Sample size calculation
From previous study, in the control group reported (mean 9.04, SD 5.22) when received music therapy treatment group, expecting treatment effect had reduced, anxiety score estimate 50% =4 Thus in treatment group estimate mean =5, in treatment group SD 4 P1= 9, P2= 5, S1 = 5, S2 = 4 We determine sample size for estimating hypothesis tests for two populations mean (two-sided test) with specified absolute precision as below n/ group = 2 [ (Z α + Z β ) σ] 2 / D2 σ = √ σ12+ σ22 / √ 2 = 4.53
n/ group = 2 [ (1.96+ 0.842 )4.53] 2 / (9-5)2 Then we can select 20 samples for each group in this study
Sampling technique and Randomized allocation
Cancer patient who had pain will be approached to determine interest in participation. Inform consent will be obtained from patients who agreed to participate in the study. This study use simple random sampling (SRS) technique for selection samples which inclusion criteria. The method of block randomization, with block size of four will be used. The allocation sequence will be generated by computer. Based on the obtained schedule, the number of sealed envelopes, which are equal to the required blocks, will be prepared and labeled. Each envelope contains the corresponding sealed allocation cards that will allocate treatments to patients. The people, who prepare the randomized scheme, will not involve in the trial. The allocation schedule will be concealed until the end of trial. The researcher need to know what type of approach to be provided to a certain patient, however, the sequence list will keep confidentially and not exposed to outcome assessors.
Outcome variable
Primary outcome variable: Pain Anxiety Secondary outcomevariable: Satisfaction for using music therapy Data analysis
Chi-square analysis will be used to determine between experimental and control groups according demographic data.
Dependent t-test between groups for mean of pain and anxiety: if normal distribution. I will be used ANCOVA for help reduce residual variation; a source of variation that affects the response variable, but was not controlled for during study design especially; baseline pain and anxiety. If there are not normal distribution data, will be used non parametric method by Mann-Whitney U test.