NCT03497507

Investigating the Effect of Acupressure on Shivering During a Cesarean Delivery in Women Who Were Previously Laboring With an Epidural

Effect of P6 Acupressure Stimulation on Shivering During Cesarean Section Under Epidural Anesthesia.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

Shivering during a cesarean section can be quite uncomfortable for the patient as well as make it difficult for the anesthesiologist to obtain vital signs. The researchers will investigate whether or not applying pressure to the P6 acupressure point during a cesarean section can treat shivering. The hypothesis is that shivering will be alleviated with acupressure.

Detailed description

The purpose of this study is to determine whether applying pressure to the left and right P6 acupoints can treat shivering in a patient undergoing a cesarean section. The hypothesis is that bilateral stimulation of P6 with pressure can stop or alleviate shivering. The primary endpoint is resolution of shivering within 15 minutes of applying bilateral pressure to P6 acupoints during a cesarean section. The secondary endpoints include: 1. Time to resolution of shivering 2. Degree of patient-reported improvement in shivering 3. Degree of practitioner-reported improvement in shivering 4. Assessment of skin irritation and/or pain at the site of acupressure vs control Patient information will be stored in a locked cabinet on labor and delivery, and that cabinet will be located in a T3-locked office. The link between subject ID and patient ID will be stored in a different office on labor and delivery, also under a T3 lock. Patients who are laboring with an epidural catheter and subsequently require a cesarean section will be selected. This patient population has a MUCH higher rate of shivering during the cesarean section as compared to patients who undergo elective scheduled cesarean sections under spinal anesthesia. By selecting this group, the investigators are not only increasing chances of identifying shivering but also decreasing variability between patient characteristics by limiting it to one type (only epidural and not spinal) and limiting the number of screen failures.

Conditions

• Shivering
• Labor
• Cesarean Delivery

Interventions

Type	Name	Description
DEVICE	Sham bracelet	Patients will wear bracelets on both hands
DEVICE	Acupressure bracelet	Patients will wear bracelets on both hands.

Timeline

• Start date: 2018-01-11
• Primary completion: 2021-10-04
• Completion: 2021-10-04
• First posted: 2018-04-13
• Last updated: 2022-10-14

Locations

1 site across 1 country: United States