The purpose of this study is to determine the synergic effects of cold therapy and music therapy to control pain during and after chest tube removal in patients undergoing heart bypass surgery. The study is a randomized clinical trial with four study groups and a factorial design. A total of 180 patients consists the sample size in this study randomly assigned into study groups (45 patients in each group) using the block sampling method. In the group A, cold therapy will use before removing the chest tube. In the group B, music therapy intervention will play before and after removal of the chest tube. For samples in the group C, the combination of music therapy and cold therapy will apply to remove a chest tube. Samples in the group D are as a control group and will not receive any intervention. Patients who have undergone heart surgery and for at least a chest tube into the pleural, they will involve in the study. If patient have severe pain, he/she will be excluded from the study. For intervention cold therapy, a ice pack with -5 temperatures will apply for 20 minutes before removing chest tube around the chest tube and chest tube will be removed by an experienced nurse. Music therapy intervention will use form 15 minutes before to 15 minutes after removal of the chest tube. In all groups, the severity of pain patients will assess before, during and 15 minutes after removal of the chest tube by using a visual analog scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012626217N1
Registration date:2016-03-09, 1394/12/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-09, 1394/12/19
Registrant information
Name
Sajad Yarahmadi
Name of organization / entity
Iran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 5655
Email address
yarahmadi.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-03-10, 1394/12/20
Expected recruitment end date
2016-08-11, 1395/05/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Synergic effect of Cold therapy and Music therapy on pain of removing chest tube in heart bypass surgery patients
Public title
The effects of Cold therapy and Music therapy in pain chest tube removal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age of 18 and a maximum of 65 years؛ Having at least one a pleural chest tube for at least 24 hours؛ Absence of vision problems and be able to read a ruler؛ Have the ability to answer questions properly researcher؛ Absence of hearing loss؛ No history of mental disorder؛ Absence of addiction to drugs or alcohol؛ Body Mass Index less than30 Kilograms per square meter؛ No sedative medication one hour before chest tube removal؛ Self ventilation؛ Keenness to listen folk music.
Exclusion criteria:
Are having pain score higher than 7 before chest tube removal؛ Unwillingness to continue to participate in the study؛ Discomfort during cold therapy؛ Using narcotic medication or sedative during intervention.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Randomization will achieve with using sample block method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Rasheed Yasemi street, higher than Mirdamad, Vali Asr street, School of Nursing and Midwifery
City
Tehran
Postal code
Approval date
2016-01-21, 1394/11/01
Ethics committee reference number
IR.IUMS.REC.1394.9311449009
Health conditions studied
1
Description of health condition studied
Coronary and valvular heart surgery
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery
Primary outcomes
1
Description
Amount of pain
Timepoint
Before،during the intervention and 15 minute after intervention
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
In cold therapy group, ice pack with temperature -5 °C will place in contact with the patient's skin for 20 minutes and chest tube will be removed after a maximum of two minutes after completion of cold therapy. The severity of patients pain in all study groups will measure before, during and 15 minutes after removal chest tube using a visual analog scale.
Category
Treatment - Other
2
Description
In music therapy group, a music from the list, which includes 15 tracks, are chosen by each patient and will play from 15 minutes before to 15 minutes after chest tube removal through headphone. The list includes local and traditional music and will play with maximum sound level of 60 decibel. The severity of patients pain in this study groups will measure before, during and 15 minutes after removal chest tube using a visual analog scale.
Category
Treatment - Other
3
Description
In patients who use the combination of music therapy and cold therapy interventions will applied for the patients before removing chest tube. The severity of patients’ pain in this study groups will measure before, during and 15 minutes after removal chest tube using a visual analog scale.
Category
Treatment - Other
4
Description
The control group will received routine nursing intervention for chest tube removal. The severity of patients’ pain in this study groups will measure before, during and 15 minutes after removal chest tube using a visual analog scale.