|Year : 2015 | Volume
| Issue : 2 | Page : 118-122
Effect of music therapy on acute postoperative analgesic requirement in unilateral complete cleft lip repair by Tennison's triangular variant technique: A double-blinded randomized control trial
Rajesh Powar1, Karan Shetty1, Manjunath Patil2, Sneha Rajuvirkar1
1 Department of Plastic and Reconstructive Surgery, KLE University, Belgaum, Karnataka, India
2 Department of Anesthesia, KLE University, Belgaum, Karnataka, India
|Date of Web Publication||17-Aug-2015|
Dr. Karan Shetty
OPD No 32, Department of Plastic and Reconstructive Surgery, J.N. Medical College, KLE Hospital and MRC, Belgaum, Karnataka
Source of Support: None, Conflict of Interest: None
This clinical study aims at evaluating the effect of music therapy on pain relief and postoperative analgesic requirement in patients with unilateral cleft lip undergoing repair by Tennison's triangular variant, in the age group of 6-12 months. A total of 105 patients fulfilling the inclusion criteria were included in this study with 50 patients receiving music therapy and 55 patients not receiving the same. The hemodynamic parameters and objective pain scale by Hanallah were assessed by a person blinded to the groups. When tested, the results showed a statistically significant decrease in the mean number of times fentanyl was required and in the mean pain score. However, there was no significant difference between the 2 groups with respect to oxygen saturation and heart rate.
Keywords: Music therapy, rescue analgesia, unilateral cleft lip repair
|How to cite this article:|
Powar R, Shetty K, Patil M, Rajuvirkar S. Effect of music therapy on acute postoperative analgesic requirement in unilateral complete cleft lip repair by Tennison's triangular variant technique: A double-blinded randomized control trial. J Cleft Lip Palate Craniofac Anomal 2015;2:118-22
|How to cite this URL:|
Powar R, Shetty K, Patil M, Rajuvirkar S. Effect of music therapy on acute postoperative analgesic requirement in unilateral complete cleft lip repair by Tennison's triangular variant technique: A double-blinded randomized control trial. J Cleft Lip Palate Craniofac Anomal [serial online] 2015 [cited 2021 May 15];2:118-22. Available from: https://www.jclpca.org/text.asp?2015/2/2/118/162966
| Introduction|| |
Music is an important part of our lives and has been a part of human culture since the beginning of civilization. Music in its purest form alleviates our mood and creates a sense of well-being with positive changes in physical and emotional components. It has been used as a form of therapy in pain relief and preoperative anxiety as noted in the modern medical literature studied in the past 30 years.  Infants and children exposed to music treatment protocols can be distracted from unpleasant symptoms, calmed during stressful events such as invasive procedures, and are less anxious while hospitalized. ,,,,
Music is an integral part of the Indian heritage and finds its origin in the Vedas. The Vedas collectively refers to a corpus of ancient Indo-Aryan religious literature that has been associated with Indian civilization, and is considered as an adherent of Hinduism to be revealed knowledge. The core is formed by "mantras" which represent hymns, prayers, and incantations.
Considering the role of music as a form of therapy, the present study was designed to validate the efficacy of the same. In this double-blinded randomized control trial, music therapy was used in patients between 6 and 12 months of age undergoing surgical repair of unilateral complete cleft lip. The hemodynamic parameters were monitored and an objective assessment of pain was done.
Observations in the realm of music therapy have shown one critical feature, that is, though being well intentioned, is undermined by a lack of research methodology. A Cochrane review of the music for pain relief,  which followed a methodological quality protocol designed by Guzmán,  revealed a poor quality in 75% of the studies. Hence, a strict quality protocol was employed for the present study. The primary aim of this study is to authenticate the role of music therapy in postoperative analgesia, based on a strict methodology so as to provide a better understanding of its role in pain relief.
| Materials and Methods|| |
The objective was to evaluate the effect of music therapy on acute pain relief and postoperative analgesic requirement in patients undergoing unilateral cleft lip repair aged between 6 and 12 months. One hundred and five patients fulfilling the inclusion criteria were included in the study.
The inclusion criteria keeping in mind the similarity of baseline statistics included:
- Age between 6 and 12 months of age.
- Complete unilateral cleft lip.
- ASA: Grade I.
- Tennison's triangular variant technique of lip repair.
The exclusion criteria were:
- ASA Grade II and above.
- On treatment with other analgesia/anticonvulsants/anticoagulants.
The patients were selected in the 6-12 months range to undergo a unilateral complete lip repair by Tennison's triangular variant to minimize the variables so as to have a strong methodological quality.
Each child was examined thoroughly and the parent/guardian were interviewed. A detailed history about any previous illness and any treatment received was noted. A detailed physical examination including weight in kilograms and age in months was noted. A written informed consent was obtained from the parents/guardians.
The children were kept nil by mouth for 4-6 h prior to surgery. They were allocated into Group A (music therapy group) or Group B (control group) according to a computer generated randomization table using an algorithm of Park and Miller with Bays Durham used by Datinf Randlist on the website www.randomisation.net.
All the patients included in this study underwent a primary unilateral lip repair by Tennison's triangular variant technique. The intra-operative management of all the patients was done with a similar protocol. At the end of surgery, all the children were reversed with intravenous (IV) glycopyrrolate 0.01 mg/kg and IV neostigmine 0.05 mg/kg.
Postoperatively in the recovery room headphones were placed and either music was played or only heaphones were applied without music depending on the group to which the baby belongs to that is,
- Group A (music therapy group): Headphone placed, and the specified music played [Figure 1].
- Group B (control group): Headphone placed, and no music played.
As the study was double-blinded, the assessors were 2 staff nurses trained in this assessment of these patients. Headphones used with the single piece playing repeatedly. Volume was set at 25 with 40 being maximum on the player.
Music therapy employed was the Ras Durga which is an evening raga played between 5.30 and 6.30 p.m. The instruments used were sitar and tabla, with 3 taals - 16 beats of the duration of 32 min which was played on loop for 5 h.
Modified Hanallah scale was used to assess the pain as it was the simplest and most reliable objective pain scoring available for the pediatric age group.  The pain was assessed for every half an hour for 5 h postoperatively, by a nurse who was trained to use this scale and was blinded to the groups. Hemodynamic parameters (pulse rate, oxygen saturation [SpO 2 ]) were monitored every 15 min for the first 90 min. Rescue analgesia of IV fentanyl 0.05 mcg/kg was administered if the pain score exceeded 3. The number and total dose of rescue analgesic (if IV fentanyl 0.05 mcg/kg) required were noted.
The pain was assessed by the Modified Hanallah Pain Scale  by a nurse trained to use the scale in the recovery room. The total score was evaluated at every half an hour intervals for 5 h.
The collected data were tabulated and analyzed statistically. The hypothesis was tested by using paired and unpaired t-test for haemodynamic parameters like SpO 2 and heart rate, and by Mann-Whitney U-test and Wilcoxin matched pair test for the pain score for both groups at different time intervals.
| Results|| |
With respect to mean number of fentanyl given, statistically significant difference was observed between the two groups with the group receiving music being given 0.6 times compared to 1.73 in the nonmusic group given at 5% level of significance (P < 0.05) [Table 1] and [Table 2].
|Table 1: Comparison of music and nonmusic therapy groups with respect to number of times fentanyl given|
Click here to view
|Table 2: Distribution number of times fentanyl given in music and nonmusic groups|
Click here to view
The difference in the percentage of increase in pain in both groups was found to be statistically significant (P < 0.05) [Table 3].
|Table 3: Comparison of music and nonmusic therapy groups with respect to pain scores at different time points by Mann-Whitney U-test|
Click here to view
In terms of the hemodynamic parameters like saturation and heart rate assessed, no significant statistical difference was observed between the two groups at 5% level that is, (P > 0.05) [Table 4] and [Table 5].
|Table 4: Comparison of music and nonmusic therapy groups with respect to SpO 2 , scores at different time points by unpaired t-test|
Click here to view
|Table 5: Comparison of music and nonmusic therapy groups with respect to HR at different time points by unpaired t-test|
Click here to view
| Discussion|| |
Pain affects the lives of patients by undermining mood, sleep patterns, physical and social functioning. Nonpharmacological interventions like music offer potential advantages of low cost, ease of provision, and safety with no side effects in comparison with other methods. The probable mechanism is said to be by increasing Mio receptors on the cell surface and increase in endorphins.  Relaxation and music have been recommended in acute pain management guidelines, on the basis of experimental studies. 
Studies related to music therapy have found that tempo is the most important factor in easing the pain with slow and flowing music of 60-72 beats/min having a positive effect. , Melodic line moving in step-wise increments (the melody consists of notes that fall closely together on a scale) with minimal interval jumps is recommended. The music should be nonlyrical, consist predominantly of low tones mostly with strings of minimal bass and, a volume of 60-70 decibels. ,
The music therapy used in this study was the Ras Durga raga, which is usually played in the evening between 5.30 and 6.30 p.m. This raga was chosen as it is known to have a very calming effect on the mind compared to the other ragas.
The Cochrane review of 2010 titled "Music for Pain Relief" involving 51 studies and 3663 subjects  evaluated the effect of music for treatment of pain in acute, chronic or cancer-related cases, for intensity, pain relief, and analgesic requirements. In acute postoperative period, the patients exposed to music had pain intensity that was 0.5 units lower on a 0-10 scale than unexposed subjects (95% confidence interval [CI]: −0.9 to −0.2). A pain relief of at least 50% was seen in four studies. It was also reported that subjects exposed to music had a 70% higher likelihood of having alleviation from pain than the unexposed subjects (95% CI: 1.21-2.37). Number needed to treat = 5 (95% CI: 4-13). 
Music therapy research, though well intentioned is often undermined by poor research methodology.  The Cochrane review also did a quality appraisal on the basis of the cornerstones for validity by Guzmán 2002.  They used 7 variables and gave a sub - score of 1 to each for:
- The method of randomization.
- Concealment of allocation.
- Blinding of the evaluators.
- Blinding of the patient.
- Similarity of baseline groups.
- Analysis of the outcomes in terms of the intention to treat principle.
- For a loss of follow-up of <20%.
It was noted that of all the studies reviewed only 13 (25%) scored 4-6 in the quality scale. Keeping this in mind, this study was designed in such a manner that all seven parameters were included, and a high methodological quality was aimed at with a score of 7/7.
With the study methodology sorted, the trial was carried out, and the results obtained have been stated in the results. In terms of the hemodynamic parameters, a 22.8% decrease in heart rate was observed in the music therapy group compared to the 7.7% increase in heart rate found in the control group over a period of 90 min. However, this is not found to be statistically significant [Table 5].
Our study noted that postoperatively the increase in pain in the test group was 125% and 192 in the control group. This was found to be statistically significant [Table 3].
Our study also showed the acute postoperative analgesic requirement was significantly less in the music therapy group with 50% of the patients not needing rescue analgesia compared to only 13.3% in the control group, which was found to be statistically significant. It was also observed that 31.8% of the patients in the control group required rescue analgesia thrice [Table 2].
Considering the results, this study shows that music therapy definitely has a positive influence in managing postoperative pain in infants as seen in terms of the changes in vital parameters like heart rate, need for rescue analgesia and assessment of pain.
| Conclusion|| |
This study has shown that music therapy is a low cost and safe adjuvant to the management of pain in the acute postoperative period in pediatric patients and hence we recommend it be added to the routine armamentarium of management.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief (Review). Cochrane Libr 2010;Issue 8.
Stouffer JW, Shirk BJ, Polomano RC. Practice guidelines for music interventions with hospitalized pediatric patients. J Pediatr Nurs 2007;22:448-56.
Grasso MC, Button BM, Allison DJ, Sawyer SM. Benefits of music therapy as an adjunct to chest physiotherapy in infants and toddlers with cystic fibrosis. Pediatr Pulmonol 2000;29:371-81.
Hatem TP, Lira PI, Mattos SS. The therapeutic effects of music in children following cardiac surgery. J Pediatr (Rio J) 2006;82: 186-92.
Malone AB. The effects of live music on the distress of pediatric patients receiving intravenous starts, venipunctures, injections, and heel sticks. J Music Ther 1996;33:19-33.
Noguchi LK. The effect of music versus nonmusic on behavioral signs of distress and self-report of pain in pediatric injection patients. J Music Ther 2006;43:16-38.
Guzmán J, Esmail R, Karjalainen K, Malmivaara A, Irvin E, Bombardier C. Multidisciplinary rehabilitation for chronic low back pain: Systematic review. BMJ 2001;322:1511-6.
Norden J, Hanallah R, Getson P. Reliability of an objective pain scale in children. J Pain Symptom Manage 1991;6:196.
Stefano GB, Zhu W, Cadet P, Salamon E, Mantione KJ. Music alters constitutively expressed opiate and cytokine processes in listeners. Med Sci Monit 2004;10:MS18-27.
Nilsson U, Rawal N, Uneståhl LE, Zetterberg C, Unosson M. Improved recovery after music and therapeutic suggestions during general anaesthesia: A double-blind randomised controlled trial. Acta Anaesthesiol Scand 2001;45:812-7.
Aldrige D. An overview of music therapy research. Ther Med 1994;2:204-16.
Robb SL, Nichols RJ, Rutan RL, Bishop BL, Parker JC. The effects of music assisted relaxation on perioperative anxiety. J Music Ther 1995;32:2-21.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]