1 Efficacy of music therapy on immediate 2 postpartum episiotomy pain: a randomized 3 controlled trial 4 5 Ravita Chaichanalap, MD*, Wipada Laosooksathit, MD*, Kittipong 6 Kongsomboon MD, MBA, PhD**, Tharangrut Hanprasertpong, MD*. 7 8 *Department of Obstetrics and Gynecology, Faculty of Medicine, Srinakharinwirot 9 university, Ongkharak, Nakornnayok 26120, Thailand 10 11 **Department of preventive and social medicine, Faculty of Medicine, Srinakharinwirot university, 12 Ongkharak, Nakornnayok 26120, Thailand 13 14 Running head: music alleviates episiotomy pain 15 Manuscript word=1847 Table=3 Figure count=1 16 17 Correspondance to: Tharangrut Hanprasertpong 18 Address: Department of Obstetrics and Gynaecology, Faculty of Medicine, 19 Srinakharinwirot University, Ongkharak, Nakhon Nayok 26120, Thailand 20 Telephone: 66-37095085-6 ext 10803 21 Email: [email protected], [email protected] 22 23 24 1 1 Abstract 2 Objectives: To evaluate the effectiveness of music therapy in alleviating immediate 3 postpartum episiotomy wound pain 4 Material and Methods: A randomized controlled trial was conducted to evaluate the 5 efficacy of music therapy in alleviating immediate pain from an episiotomy wound. 6 Uncomplicated singleton vaginal delivery women with the second degree or less 7 episiotomy wound at Delivery and Postpartum Inpatient Unit, Department of 8 Obstetrics and Gynecology, Faculty of Medicine, Srinakharinwirot University, 9 Thailand were enrolled into the study. Visual analog scale (VAS) scoring was used 10 for comparing pain levels. 11 Results: One hundred postpartum women were enrolled in our study. Baseline 12 characteristics such as age, degree of episiotomy wound tear were similar between 13 both groups. The median pain VAS score was statistically significantly lower in the 14 music group than in the control group at the end of the 2nd hour after finish of 15 episiotomy wound repairing process [24.0 millimeters (8.3-41.5) and 36.5 millimeters 16 (20.0-53.3); p-value < 0.001]. The median pain VAS score was statistically 17 significantly lower in the music group than in the control group at the end of 6th hour 18 after finish of episiotomy wound repairing process [12.0 millimeters (3.0-21.0) and 19 22.0 millimeters (15.0-38.0); p-value < 0.001] 20 Conclusion: Music therapy is effective for reducing the perceived immediate 21 postpartum pain of an episiotomy wound. 22 Keywords: episiotomy pain, music therapy, singleton pregnancy 23 24 25 2 1 2 ประสิทธิภาพของดนตรีบ าบัดในการบรรเทาความรู้สึกเจ็บปวดจากแผลฝี เย็บช่วงหลัง 3 คลอดทันที: การศึกษาแบบสุ่มและมีกลุ่มควบคุม 4 5 รวิตา ชัยชนะลาภ, พบ*, วิภาดา เหล่าสุขสถิตย์, พบ*, กิตติพงษ์ คงสมบูรณ์, พบ**, ธารางรัตน์ หาญ 6 ประเสริฐพงษ์, พบ*. 7 8 บทคัดย่อ 9 วตั ถุประสงค์: เพื่อศึกษาประสิทธิภาพของดนตรีบา บดั ต่อการบรรเทาความรู้สึกเจ็บปวดจากแผลฝีเยบ็ ช่วง 10 หลังคลอดทันที 11 วัสดุและวิธีการ: การศึกษาแบบสุ่มและมีกลุ่มควบคุมเพื่อประเมินประสิทธิภาพของดนตรีบา บดั ต่อการ 12 บรรเทาความรู้สึกเจ็บปวดจากแผลฝีเยบ็ ช่วงหลงั คลอดทนั ที หญิงหลังคลอดทางช่องคลอดซ่ึงได้รับการ 13 ตัดฝีเย็บระดบั 2 หรือนอ้ ยกวา่ โดยไม่มีอาการแทรกซอ้ นของการคลอด ที่ห้องคลอดและหอผู้ป่วยในหลัง 14 คลอดของภาควิชาสูติศาสตร์นรีเวชวิทยา คณะแพทยศาสตร์ มหาวิทยาลัยศรีนครินทรวิโรฒ ซึ่งได้รับคา 15 เชิญให้ร่วมในการศึกษาน้ี โดยใช้มาตรวัดความเจ็บปวดด้วยสายตาเปรียบเทียบระดบั ความปวดระหว่าง 16 กลุ่มศึกษาและกลุ่มควบคุม 17 ผลการศึกษา: หญิงหลังคลอด 100 คน ไดร้ ับเชิญให้เขา้ ร่วมในการศึกษาน้ี ลกั ษณะพ้ืนฐานของผูเ้ ขา้ ร่วม 18 การศึกษาเช่น อายุ ระดับความรุนแรงของการฉีกขาดแผลฝี เย็บเหมือนกันในท้ังสองกลุ่มผูเ้ ข้าร่วม 19 การศึกษา ค่ากลางของระดับความเจ็บปวดวัดโดยใช้มาตรวัดความเจ็บปวดด้วยสายตา ณ. เวลา 2 ชว่ั โมง 20 หลงั สิ้นสุดการเยบ็ แผลฝีเยบ็ ของกลุ่มศึกษาต่า กว่ากลุ่มควบคุมอยา่ งมีนยั ส าคญั ทางสถิติ [24.0 มิลลิเมตร 21 (8.3-41.5) และ 36.5 มิลลิเมตร (20.0-53.3) ตามลาดับ ; ค่า p < 0.001] ค่ากลางของระดบั ความเจ็บปวดวัด 22 โดยใช้มาตรวัดความเจ็บปวดด้วยสายตา ณ. เวลา 6 ชว่ั โมงหลงั สิ้นสุดการเยบ็ แผลฝีเยบ็ ของกลุ่มศึกษาต่า 3 1 กว่ากลุ่มควบคุมอย่างมีนัยส าคญั ทางสถิติ [12.0 มิลลิเมตร (3.0-21.0) and 22.0 มิลลิเมตร (15.0-38.0) 2 ตามลาดับ ; คา่ p < 0.001] 3 สรุป: ดนตรีบาบัดมีประสิทธิภาพในการบร รเทาความรู้สึกเจบ็ ปวดจากแผลฝีเยบ็ ช่วงหลงั คลอดทนั ที 4 คาส าคัญ: เจ็บปวดแผลฝีเย็บ ดนตรีบาบัด หญิงต้งั ครรภเ์ ดี่ยว 5 6 Introduction 7 Episiotomy is a common obstetric procedure which is often performed during 8 a vaginal delivery in Thailand. Benefits of the episiotomy include decreasing third- 9 degree vaginal tearing, prevention of pelvic floor muscle relaxation, and they are 10 easier to repair and heal better than spontaneous lacerations (1). However, pain and 11 edema in the episiotomy area following the birth can cause discomfort and interfere 12 with ambulation, breastfeeding, slower resumption of normal sexual function and 13 defecation and urination functions.(2) Many modalities have been introduced for 14 reducing episiotomy pain, such as administration of local anesthetics (lidocaine gel, 15 spray or injection, oral or intravenous pain killer)(3-4). However all of these methods 16 involve adverse effects such as rash, gastrointestinal tract disturbance or allergic 17 reactions. 18 Music therapy is an alternative medicine which has been found to be effective 19 in reducing in many medical situation, including laparoscopic cholecystectomy and 20 open heart surgery (5-6). Music therapy functions to control pain via the pain gate 21 control theory, which states that pain fibers from injured tissue activate the pain gate 22 at the spinal gating system of the spinal cord. Music closes the pain gate and therefore 23 inhibits pain signals from being transmitted from the wound site to the brain. 24 Furthermore, it is hypothesized that music therapy activates the anterior pituitary 25 gland to release endorphins which relieve pain. Relaxation music without lyrics 4 1 included synthesizer, harp, piano, orchestra and jazz with slow beat 60-80 beats per 2 minute were used post-operative for 60 minutes and pain was reduced approximately 3 30 percent (7-9). However, to date there have no study which have evaluated the 4 effectiveness of music therapy in alleviating the pain arising from an episiotomy in 5 immediate postpartum period. Thus, we conducted this study which aimed to analyze 6 the efficacy of music therapy on episiotomy wound pain in uncomplicated vaginal 7 deliveries. 8 9 Material and Methods 10 Subjects 11 A prospective randomized controlled study was conducted at the Delivery and 12 Postpartum Inpatient Unit, Department of Obstetrics and Gynecology, Faculty of 13 Medicine, Srinakharinwirot University, Thailand between March and December 2016. 14 At our institute, all pregnant women were delivered in private room one by one. 15 Uncomplicated singleton vaginal delivery women with the second degree or less 16 episiotomy wound were enrolled into our study. The exclusion criteria were 17 women who received anesthesia more than a local infiltration of xylocaine such as a 18 pudendal nerve block, the presence of birth passage hematoma, cervical tearing 19 requiring surgical suturing, third or fourth degree episiotomy tearing, hearing deficit 20 or impaired balance and allergic to acetaminophen. 21 22 Study procedure 23 The study was approved by the institute ethics committee (SWUEC/E- 24 048/2559) and the Thai Clinical Trials Registry (TCTR 20160325001). During the 25 early active phase of labor, we explained about our study to all singletons which 5 1 possible to success their deliveries through the vaginal route including how to assess 2 the pain VAS score. Intrapartum management was performed as usual. Immediately 3 after delivery (including placenta), if the physician found a second degree vaginal tear 4 which needed suturing, we asked the patient if she would agree to participant in our 5 study, if she would give her informed consent. Then the participants were randomized 6 into two groups using a computerized block of four. Concealment of allocation was 7 ensured by using serially numbered, sealed opaque envelopes. The envelopes were 8 opened after the informed consent was received by the nurse who prepared the music 9 but was not involved the pain score measurements. The participants’ demographic 10 data were collected. Participants were classified into high risk and low risk groups by 11 antenatal history. “High risk” was defined as being complicated with a medical 12 condition such as diabetic mellitus, hypertension, etc. If none of any complication, we 13 defined as “Low risk”. Administration of an analgesic drug during the active 1st stage 14 of labor was recorded. The physician who delivered the baby and sutured the 15 episiotomy wound was blinded to the study. At our hospital, the obstetrician locally 16 injects 1% lidocaine with adrenaline just before performing an episiotomy. Additional 17 injections can be provided during the episiotomy repair at the patient’s request 18 because of breakthrough pain. Total lidocaine usage in each participant was recorded. 19 Polyglactin 910 sutures (Vicryl) were used for suturing the episiotomy in all 20 participants. A continuous suturing technique is normally used, although an 21 interrupted suturing technique can be done as indicated for hemostasis. The duration 22 of the episiotomy repair was timed from the first needle puncture until the suture- 23 check rectal examination was finished. The music was introduced as the suturing was 24 finished. 6 1 A Yellow Brick Cinema-relaxing piano music with rhythm of 70 beats per 2 minute was used in our study. The music was played through a two-earphone device