Clinical trial NCT03024411: Music and/or Video Games During Labor
Official title: Music and/or Video Games for Pain Management During Induction of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 253
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Data are lacking regarding the use of music and video games for the management of pain in labor. Pregnant women that are scheduled for labor induction with Foley bulb after 37 weeks will be approached for participation in the study. Patients will be randomized to a music/video games group and a non-music/video games group. Those randomized to group with music/video games will be given an iPod for those purposes.The primary outcome will be the time for patients to request pain medications after Foley bulb placement. The two groups will be compared for differences in pain outcomes.

Detailed description: For decades, investigators have been evaluating the efficacy of music for pain relief. Music for pain management has been studied in the field of palliative care, oncology, physical therapy, pediatrics, post-operative procedural pain and childbirth. A 2006 Cochrane review found that listening to music reduces pain intensity levels and opioid requirements, but the magnitude of the benefits is small and the clinical importance unclear. Previous studies in obstetrics vary, as some evaluate music for pain control at time of cesarean section and others during labor. A 2014 study investigated the effect of progressive muscle relaxation exercises and music on low back pain and quality of life in pregnancy. Some previous studies investigating music or white noise for pain control during labor revealed beneficial results. One prospective trial of 25 women found little practical value of audio-analgesia.

However, most studies evaluating music therapy for pain relief in labor were limited by sample size. Specifically, a 2011 Cochrane review investigating randomized controlled trials comparing relaxation methods as a method of pain management in labor found insufficient evidence for the role of music and audio-analgesia and the need for further research. Excluded from this review was a trial by Phumdoung et al. due to the inability to obtain additional methodological and statistical information from the authors. More recently, a randomized controlled trial (RCT) done in Turkey randomized 156 women into a music and control group. Mothers in the music group were found to have a significantly lower level of pain and anxiety in all stages of labor. Pain and anxiety were evaluated by a visual analog scale. While this evidence is the best to date, there is a lack of generalizability for other populations and the primary outcome was subjective. A 2012 systematic review of video games found improvement in psychological therapy, physical therapy, physical activity, clinical skills, health education, pain distraction, and disease self-management outcomes.

Labor induction is a common obstetrical procedure. Labor results in severe pain for many women and typically requires medical treatment for pain relief. Types of analgesia for pain control on labor include parenteral (Fentanyl, Nalbuphine, Meperidine) and regional (spinal, epidural, combined spinal epidural) analgesia. However, all types of analgesia pose risks to the mother and fetus. Administration of parenteral agents result in minimal-to-absent reduction in pain scores and high doses affect fetal heart rate tracing and later increase the number of infants requiring naloxone therapy. While regional analgesia provides superior pain relief, common complications include hypotension, fever, postdural puncture headache, transient fetal heart rate decelerations, pruritus, and inadequate pain relief. Due to these risks and other reasons, many women prefer to go through labor without medical therapies or with minimal medical therapy and desire complementary therapies to help manage their pain. Data are lacking regarding the use of music and video games for the management of pain in labor.

In view of the lack of good quality evidence from well designed RCTs, we propose a randomized controlled trial to determine the utility of music and video games for pain management during induction of labor. Pregnant women that are scheduled for labor induction with Foley bulb after 37 weeks will be approached for participation in the study. The study informed consent will be obtained. Patients will be randomized to a music/video games group (group 1) and a non-music/video games group (group 2). Those randomized to group with music/video games will be given an iPod for those purposes. The iPod will include free music applications such as Pandora as well as some of the most commonly downloaded games. Randomization will be performed using a computer generated random list of numbers assigning patients to the 2 groups of the study. Randomization will occur after the Foley bulb is placed. Study assignment and the list of random number assignments will be kept secure in opaque envelopes until the end of the study.

Prospective subjects presenting for induction of labor in labor and delivery, and willing to participate in the study will be evaluated for their eligibility. After the Foley bulb is placed, patients will be randomized. Those assigned to the music/video game group will be given an iPod to use during labor. These patients will have the choice of listening to music via earphones or a speaker which amplifies the sound. Patients assigned to the non-music/video game group will not be given an iPod and will be asked to avoid using their own personal devices (if applicable) as much as possible. Understanding that patients randomized to the non-music/video game may still elect to use their own electronic devices, time of use of electronics for music/video game purposes will be recorded in both groups with assistance from the patients and nursing staff.

All nurses will be educated regarding the study procedure. Nurses will not ask any patient if they desire pain medicine to avoid prompting the patient. Every patient enrolled will receive a Foley bulb inserted just superior to the internal cervical os and then inflated with normal saline for mechanical dilation of the cervix. The Foley bulb will be placed under traction by taping the tubing to the patient's leg. No additional traction will be applied to the Foley bulb after placement and initial traction. After twelve hours, if the Foley balloon is still in place, the Foley balloon will be deflated and removed and the remainder of obstetrical care will be left to the discretion of the supervising faculty. After six hours or after epidural placement the use of music/video games will be continued or ceased pending patient desire.

The study will be explained as in the consent form and if agreed, patients will elect either to participate in the study or not after all risks and benefits are explained. Data to be collected will consist of age, gravida/para, gestational age, body mass index, time and date of intervention, time and date of delivery, mode of delivery, bishop score at admission (bishop score is a score that assesses cervical readiness for delivery and is measured by digital pelvic exam. A score \< 7 is considered unfavorable and is an indication for cervical ripening to induce labor), time and date of pain medication request, type and amount of parenteral medication, time from Foley bulb placement until expulsion, patient pain score by visual analog scale, and patient satisfaction. Data will be extracted from patients' medical records as well as from direct interview with the patient. If elected to participate consents will be obtained and stored in patient chart. A copy of the consent will be given to the patient. Patients will be consented in either English or Spanish by research personnel fluent in the language. The primary outcome will be the time for patients to request pain medications after Foley bulb placement. The two groups will be compared for differences in pain outcomes.

Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years old
* Pregnant women \> or = 37 weeks gestation
* Induction of labor using Foley bulb
* Singleton gestation
* Vertex fetal presentation
* Intact membranes

Exclusion Criteria:

* Any contraindication for vaginal delivery (malpresentation, placenta previa)
* Previous cesarean section
* Gestational age \<37 weeks gestation
* Receiving pain medication at time of Foley bulb placement
* Chronic narcotic use (methadone, suboxone, oxycodone, etc.)
* Visual or auditory impairment.

Primary outcomes:
measure: Time until patient request for pain medication after Foley bulb placement.
timeFrame: From time of Foley bulb placement (randomization) until time of request for pain medicine or time of delivery, whichever came first, assessed up to 3 days.
Secondary outcomes:
measure: Parenteral medication
timeFrame: From time of Foley bulb placement (randomization) until time of delivery, assessed up to 3 days.
measure: Visual analog scale (VAS) pain score
timeFrame: Six hours from time of Foley bulb placement (randomization).
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch at Galveston
name: Christopher L Dixon, M.D.
role: PRINCIPAL_INVESTIGATOR
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