ShiveringNCT03497507
Investigating the Effect of Acupressure on Shivering During a Cesarean Delivery in Women Who Were Previously Laboring With an Epidural
A study testing Acupressure bracelet in people with Shivering and Labor, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shivering, Labor, Cesarean Delivery
- What is being tested?
- Acupressure bracelet
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2018to 4 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- a patient has to be classified as an American Society of Anesthesiology (ASA) physical status I, II, or III, laboring with an epidural catheter, and subsequently taken for a non-emergent cesarean section under epidural anesthesia with a core body temperature range of 35.5-38.0 degrees Celsius during shivering.
Who cannot join
- ASA status 4 or higher
- core body temperature lower than 35.5 or higher than 38.0
- thyroid disease
- systemic infection
- emergent cesarean section,
- a psychiatric, cognitive or medical condition that would compromise adherence to the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Effect of P6 Acupressure Stimulation on Shivering During Cesarean Section Under Epidural Anesthesia.
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.
Read the 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:
- Time to resolution of shivering
- Degree of patient-reported improvement in shivering
- Degree of practitioner-reported improvement in shivering
- 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
- Being tested
- Sham bracelet, Acupressure bracelet
- Keywords
- Shivering, Cesarean delivery, acupressure, P6 acupoint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham braceletDevice
Patients will wear bracelets on both hands
Acupressure braceletDevice
Patients will wear bracelets on both hands.
| Study group | Role | What they receive |
|---|---|---|
| Sham bracelet | Placebo comparator | Patients randomized to sham group will wear bracelets on both hands which will not apply acupressure Receives: Device: Sham bracelet |
| Acupressure bracelet | Experimental | Patients randomized to the experimental group will wear bracelets on both hands which will apply acupressure to the P6 acupoint. Receives: Device: Acupressure bracelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of resolution of shivering at 15 minutes
Incidence of resolution of shivering within 15 minutes of applying bilateral pressure to P6 acupoints during a cesarean section.
Measured: up to 15 minutes
Secondary outcomes (5)
Time to resolution of shivering
Time to resolution of shivering
Measured: up to 15 minutes
Degree of resolution of shivering
Degree of patient-reported improvement in shivering as measured by Crossley \& Mahajan shivering scale: 0 = no shivering;1 = no visible muscle activity but piloerection, peripheral vasoconstriction, or both are present (other causes excluded); 2 = muscular activity in only one muscle group; 3 = moderate muscular activity in more than one muscle group but no generalized shaking; 4 = violent muscular activity that involves the whole body.
Measured: up to 15 minutes
Degree of practitioner-reported improvement in shivering
Degree of practitioner-reported improvement in shivering as measured by Crossley \& Mahajan shivering scale: 0 = no shivering;1 = no visible muscle activity but piloerection, peripheral vasoconstriction, or both are present (other causes excluded); 2 = muscular activity in only one muscle group; 3 = moderate muscular activity in more than one muscle group but no generalized shaking; 4 = violent muscular activity that involves the whole body.
Measured: up to 15 minutes
Number of participants with skin irritation
Number of participants with skin irritation at the site of acupressure obtained by patient self-reporting
Measured: up to 15 minutes
Number of participants with pain
Number of participants with pain at the site of acupressure obtained by patient self-reporting
Measured: up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start11 Jan 2018
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShiveringStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once an obstetrician determines that a patient laboring with an epidural catheter should have a non-emergent cesarean section instead of continuing labor, the clinical anesthesiologist will contact the research team. A member of the research team will contact the patient while she is still in the labor and delivery room, at which time informed consent would be obtained.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Katz, Icahn School of Medicine at Mount Sinai
- Investigators
- Jeffery Zahn, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497507
- Sponsor's protocol ID
- GCO 17-2495
- Status last verified
- Oct 2022
- First submitted
- 6 Apr 2018
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of P6 Acupressure Stimulation on Shivering During Cesarean Section Under Epidural Anesthesia.
- ClinicalTrials.gov ID
- NCT03497507
- Acronym / sponsor ID
- GCO 17-2495
- Conditions
- Shivering, Labor, Cesarean Delivery
- Keywords
- Shivering, Cesarean delivery, acupressure, P6 acupoint
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Time to resolution of shivering
- Degree of patient-reported improvement in shivering
- Degree of practitioner-reported improvement in shivering
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Once an obstetrician determines that a patient laboring with an epidural catheter should have a non-emergent cesarean section instead of continuing labor, the clinical anesthesiologist will contact the research team. A member of the research team will contact the patient while she is still in the labor and delivery room, at which time informed consent would be obtained.
| Arm | Type | Receives |
|---|---|---|
| Sham bracelet | Placebo comparator | Device: Sham braceletPatients randomized to sham group will wear bracelets on both hands which will not apply acupressure |
| Acupressure bracelet | Experimental | Device: Acupressure braceletPatients randomized to the experimental group will wear bracelets on both hands which will apply acupressure to the P6 acupoint. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- a patient has to be classified as an American Society of Anesthesiology (ASA) physical status I, II, or III, laboring with an epidural catheter, and subsequently taken for a non-emergent cesarean section under epidural anesthesia with a core body temperature range of 35.5-38.0 degrees Celsius during shivering.
Key exclusion criteria (6 listed)
- ASA status 4 or higher
- core body temperature lower than 35.5 or higher than 38.0
- thyroid disease
- systemic infection
- emergent cesarean section,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham braceletPatients will wear bracelets on both hands | Device | Sham bracelet |
| Acupressure braceletPatients will wear bracelets on both hands. | Device | Acupressure bracelet |
Primary outcome
Incidence of resolution of shivering at 15 minutes
Time frame: up to 15 minutes
Incidence of resolution of shivering within 15 minutes of applying bilateral pressure to P6 acupoints during a cesarean section.
5 secondary outcomes
Time to resolution of shivering
Time frame: up to 15 minutes
Degree of resolution of shivering
Time frame: up to 15 minutes
Degree of practitioner-reported improvement in shivering
Time frame: up to 15 minutes
Number of participants with skin irritation
Time frame: up to 15 minutes
Number of participants with pain
Time frame: up to 15 minutes
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Shivering
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Shivering, Post-Spinal Shivering
Not yet recruitingPhase 4
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
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Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery Zahn, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure bracelet in people with Shivering and Labor, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of resolution of shivering at 15 minutes (time frame: up to 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022; AzTrials last refreshed its copy on 26 Oct 2026.