Study Design
It is a randomized clinical trial
Place: Erasto Gaertner Hospital Bone Marrow Transplant Unit. The research developed between May/2018 and August/2019
Population: Adult patients undergoing hematopoietic stem cell transplantation (HSCT) Autologous.
Approved by the ethics committee in the research of the Erasto Gaertner Hospital Certificate of Ethical Presentation and Appreciation (CAAE) number 82882017.6.0000.0098 and Registered in (REBEC) Registration Brazilian Clinical Trials RBR 3h4csb
Sample Calculation: The calculation of the sample size based on a previous pilot study for which an average of 2.9 identified for the pain score with a standard deviation of 2.4. It was felt that this group corresponded to the control group of the new study, and a minimal difference in the pain score of 1 point higher in the Experimental group would be clinically relevant. For a significance level of 5% and a test power of 80%, it would require at least 20 cases in each group (Control Group and Experimental Music therapy Group).
Randomization: Before starting the research, the randomization of 45 numbers. Carried out by the program http://www.randomizer.org, which were inserted into an opaque envelope in the randomized order and the envelopes numbered from the outside in the sequential order from 1 to 45.
The random selection for allocation of the patient to the groups took place as follows: After the patient agreed to participate in the research and having signed the FICF, the envelope was opened in front of the patient and it was agreed that the “even” number would comprise the group that will receive the music therapy intervention, referred to as the Experimental Music Therapy Group (GEM), and the 'odd' number will make up the Control Group (GC), the group that will not receive the music therapy intervention.
INCLUSION CRITERIA
The invitation made to each patient submitted to (HSCT) Autologous between 18 and 70 years of age, if the patient accepted to participate in the research, he/she would then have to sign a free, prior and informed consent form (FPIC).
METHOD
Live music through music therapy techniques provided by a qualified music therapist performing popular songs that are part of the social musical cultural identity of the patient For example: the music therapist and patient sing together the latter’s preferred songs with guitar accompaniment, with the patient following the rhythm of the music playing percussion instruments such as: bongo, tambourine, bells, triangle or maracas, among others, in an interactive process, using music therapy techniques such as: Popular songs chosen by patients with singing and improvisation with rhythmic production activities. The sessions were individual and took place in the room beside the patient's bed, three times a week, with each session in the Experimental Music Therapy Group lasting 30 minutes.
A one-hour session would be ideal, but due to bone marrow aplasia conditions (low immunity), this would cause excessive fatigue in patients. Through an earlier pilot study, found that one hour per week, divided into two 30-minute sessions, one on Tuesday and another on Thursday, would be more appropriate given the patients' conditions.
Live music has tremendous power to energize patients and provides greater emotional impact. In addition, the human presence of the music therapist results in patients feeling welcome, clinical listening, attention, resonance and enhancement of the interactive expressions of the patient.
Nausea and pain levels in the Experimental Music Therapy Group measured using a visual analogue scale (VAS) [7], before and after the music therapy session.
Apply the visual analog scale (VAS), to measure the levels of nausea and pain in the Control Group (CG) that received just the standard treatment.
MATERIAL
[7] Visual Analog Scale (VAS) was used to assess the dependent variables nausea and pain, It was collected quantitative data regarding the subjective responses of patients to visual analog scale (VAS) applied before and after the intervention in EMG. And the data collected also in the CG did not receive music therapy.
(VAS) visual analog scale, is a numerical scale ranging from 0 to 10, it is widely used to measure the intensity of pain, but also can be used to measure pain, breathlessness, anxiety, fatigue, and moods.
Operating range (nausea=0 “no nausea” nausea=10 “extreme nausea”), (pain=0 “no pain”, pain=10 “extreme pain”).
Demographic Questionnaire Clinical It was also collected personal data and clinical patient demographics, such as name, address, age, sex, religion, Education, Social Class, diagnosis and resources cells.
Questionnaire of music therapy to collect musical information, musical preferences, the family, the parents and patients. Possession of musical information the music therapist preparing a unique repertoire for each patient, and Thus begins the process of the sessions interventions production of live music by the techniques of music therapy recreation of songs and improvisation with rhythmic production activities.
Prior and informed consent form (FPIC) All patients signed an informed consent.