PainNCT06678893
Ear Acupuncture for Pain and Anxiety Management in Early Labor
A study testing Acupuncture Needle on an adhesive and Adhesives in people with Pain and Anxiety, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
This is a study evaluating the feasibility and acceptability of ear acupuncture for the management of pain and anxiety in early labor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Acupuncture Needle on an adhesive and Adhesives
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to 1 Jan 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older, Spanish or English speaking, with term (37+ weeks pregnant) singleton pregnancy, in early labor (as defined as less than 6cm dilated and having at least 2 contractions in 10 minutes)
Who cannot join
- Younger than 18 years old, non-english or spanish speaking, greater than 6cm or not having consistent contractions (less than 2 contractions in 10 minutes), preterm and/or multiple gestation pregnancy, received morphine or nitrous oxide within the last 2 hours, congenital anomalies/wound/skin disorders of the ear, or prior adverse reaction to acupuncture, adverse reactions or allergies to adhesives.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Infants Hospital
Providence, Rhode Island, 02905
About this study
Official title: Pilor Trial of Auricular Acupuncture for Latent Labor-Related Pain and Anxiety
This is a study evaluating the feasibility and acceptability of ear acupuncture for the management of pain and anxiety in early labor.
Read the detailed description
This double blinded randomized controlled pilot study will take place in the Emergency Department of Women and Infants Hospital (WIH) in Providence Rhode Island. This study seeks to assess feasibility and acceptability utilizing the 5 Needle Protocol of Auricular Acupuncture (5NP, AA) during early labor for management of pain and anxiety. At the time of emergency department evaluation at Women and Infants Hospital for a chief complaint of painful contractions, the investigators will enroll 40 pregnant people as a feasibility sample investigating the impact of auricular acupuncture (AA) on patient-reported pain and anxiety in early labor. Participants will be randomized to either AA using the 5 Needle protocol versus placebo acupuncture. While the data on the efficacy of auricular acupuncture for pain and anxiety is mounting, evidence for utility in treating labor pain is limited. This proposal will be one of the first to randomize pregnant people presenting with concern for pain or anxiety related to labor contractions to this potential treatment.
The investigator's long-term goal is to find an effective treatment option for a common labor complaint while improving satisfaction with pain management in the Emergency Department. Given this is a pilot study, the primary objective is to determine feasibility of implementing a randomized control trial evaluating the effect of auricular acupuncture as an initial treatment for improving perceived pain and anxiety symptoms related to contractions. The central hypothesis is that this is indeed feasible and acceptable in the Emergency Department setting of Women and Infants Hospital in Rhode Island. The secondary objective is to assess the trend that auricular acupuncture has on pain and anxiety scores, as well as on heart rate and blood pressure. Though the sample size is aimed to assess feasibility and will not be sufficiently powered for an efficacy analysis, if trends suggest that auricular acupuncture decreases pain and/or anxiety sores, further investigation with a larger randomized control trial will be warranted.
Eligible participants for this trial include Spanish or English speaking patients 18 years or older who are in early labor with a singleton pregnancy greater than or equal to 37+0 weeks gestation, and willing to be randomized to receive auricular acupuncture versus placebo. Early labor will be defined as less than 6 centimeters dilated and experiencing at least 2 contractions in ten minutes, per patient report and/or tocometry. Exclusion criteria include patients less than 18 years of age, non-Spanish or English-speaking patients, multi-gestation, preterm labor, greater than or equal to 6 cm dilated, less than 2 contractions in 10 minutes, morphine or nitrous oxide administration within the last two hours, congenital anomalies, open wounds or skin disorders of the ear, previous adverse reactions to acupuncture and/or allergies or contraindications to adhesives.
- Being tested
- Acupuncture Needle on an adhesive, Adhesives
- Keywords
- Acupuncture, Auricular Acupuncture, Early labor, Pain, Anxiety
- Medical subject headings
- Pain, Anxiety Disorders, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture Needle on an adhesiveDevice
This study utilizes acupuncture needs on small adhesives which will be placed according to the 5NP NADA Auricular Acupuncture Protocol.
AdhesivesDevice
For those randomized to the placebo arm, adhesives without needles will be placed according to the 5NP NADA Auricular Acupuncture Protocol placement
| Study group | Role | What they receive |
|---|---|---|
| Auricular Acupunture | Experimental | Participants randomized to this arm will undergo treatment with the 5 Needle Protocol of Auricular Acupuncture Receives: Device: Acupuncture Needle on an adhesive |
| Placebo | Placebo comparator | Participants randomized to this arm will undergo treatment with small adhesives without needles placed in the same configuration as the 5 Needle Protocol Receives: Device: Adhesives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of eligible participants that consent to being a part of the study
The investigators are evaluating if doing a randomized control trial on acupuncture in early labor is feasible in the setting of the Emergency Department of Women and Infants Hospital in Rhode Island by evaluating how many eligible patients consent to being a part of the study
Measured: up to 3 months
Likert scale 1 to 5 of patient satisfaction with treatment experience
We are evaluating if doing acupuncture during labor is acceptable to patients in the emergency department of Women and Infants Hospital by using a Likert scale questionnaire evaluating their experience of receiving the intervention and their likelihood of doing the intervention were it to be offered again. The lowest value of the scale is 1 and the highest is 5. A higher number indicates higher level of satisfaction with the intervention performed.
Measured: up to 3 months
Secondary outcomes (2)
Visual Analogue Scale pain score
The investigators are comparing visual analogue scale pain scores pre and post acupuncture versus placebo intervention to see if there is a reduction in pain score that correlates with our intervention. This study is not powered to prove causality but we will look for correlation as a secondary outcome. The minimum value on the scale is 0 and the maximum is 10. A higher number indicates higher levels of pain.
Measured: 30 minutes
Visual Analogue Scale Anxiety Scores
The investigators will be evaluating visual analogue scale Anxiety scores pre and post intervention of placebo versus acupuncture to see if there is a reduction in anxiety that correlates with our intervention. This study is not powered to prove causality however will look for correlation as a secondary outcome. The minimum value on the scale is 0 and the maximum is 10. A higher number indicates higher levels of anxiety.
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start5 Nov 2024
- Primary completion15 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- This is a pilot study of a randomized control trial. Consented participants will be randomized to either auricular acupuncture or placebo intervention. Blood pressure, heart rate, and VAS pain and anxiety scores will be recorded and compared pre and post intervention in both treatment arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kalin Gregory-Davis, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678893
- Sponsor's protocol ID
- 2145161-3
- Status last verified
- Apr 2025
- First submitted
- 29 Oct 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: As of now, this is a single site feasibility study. If we move forward with a larger multi-center study, we will plan to share IPD but at this time, given it is a single site and feasibility study we do not have a plan to share IPD with anyone other than the key study personnel.
Publications
Levett KM, Smith CA, Dahlen HG, Bensoussan A. Acupuncture and acupressure for pain management in labour and birth: a critical narrative review of current systematic review evidence. Complement Ther Med. 2014 Jun;22(3):523-40. doi: 10.1016/j.ctim.2014.03.011. Epub 2014 Apr 13.
PubMed 24906592Baumler P, Zhang W, Stubinger T, Irnich D. Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. BMJ Open. 2021 Sep 6;11(9):e045961. doi: 10.1136/bmjopen-2020-045961.
PubMed 34489268Zhang CS, Yang AW, Zhang AL, May BH, Xue CC. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. doi: 10.1089/acm.2013.0238. Epub 2013 Oct 19.
PubMed 24138333Vakilian K, Ghaemmaghami M, Sheikhganbari N, Shabani F, Vahedi M. Reducing Labor Anxiety with Auriculotherapy: A Randomized Clinical Trial Study. Chin J Integr Med. 2022 May;28(5):440-444. doi: 10.1007/s11655-021-3452-0. Epub 2021 Sep 28.
PubMed 34581941Smith CA, Collins CT, Levett KM, Armour M, Dahlen HG, Tan AL, Mesgarpour B. Acupuncture or acupressure for pain management during labour. Cochrane Database Syst Rev. 2020 Feb 7;2(2):CD009232. doi: 10.1002/14651858.CD009232.pub2.
PubMed 32032444King HC, Hickey AH, Connelly C. Auricular acupuncture: a brief introduction for military providers. Mil Med. 2013 Aug;178(8):867-74. doi: 10.7205/MILMED-D-13-00075.
PubMed 23929047Thomson G, Feeley C, Moran VH, Downe S, Oladapo OT. Women's experiences of pharmacological and non-pharmacological pain relief methods for labour and childbirth: a qualitative systematic review. Reprod Health. 2019 May 30;16(1):71. doi: 10.1186/s12978-019-0735-4.
PubMed 31146759
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilor Trial of Auricular Acupuncture for Latent Labor-Related Pain and Anxiety
- ClinicalTrials.gov ID
- NCT06678893
- Acronym / sponsor ID
- 2145161-3
- Keywords
- Acupuncture, Auricular Acupuncture, Early labor, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 7 Nov 2024 (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.
This is a study evaluating the feasibility and acceptability of ear acupuncture for the management of pain and anxiety in early labor.
Detailed description
This double blinded randomized controlled pilot study will take place in the Emergency Department of Women and Infants Hospital (WIH) in Providence Rhode Island. This study seeks to assess feasibility and acceptability utilizing the 5 Needle Protocol of Auricular Acupuncture (5NP, AA) during early labor for management of pain and anxiety. At the time of emergency department evaluation at Women and Infants Hospital for a chief complaint of painful contractions, the investigators will enroll 40 pregnant people as a feasibility sample investigating the impact of auricular acupuncture (AA) on patient-reported pain and anxiety in early labor. Participants will be randomized to either AA using the 5 Needle protocol versus placebo acupuncture. While the data on the efficacy of auricular acupuncture for pain and anxiety is mounting, evidence for utility in treating labor pain is limited. This proposal will be one of the first to randomize pregnant people presenting with concern for pain or anxiety related to labor contractions to this potential treatment.
The investigator's long-term goal is to find an effective treatment option for a common labor complaint while improving satisfaction with pain management in the Emergency Department. Given this is a pilot study, the primary objective is to determine feasibility of implementing a randomized control trial evaluating the effect of auricular acupuncture as an initial treatment for improving perceived pain and anxiety symptoms related to contractions. The central hypothesis is that this is indeed feasible and acceptable in the Emergency Department setting of Women and Infants Hospital in Rhode Island. The secondary objective is to assess the trend that auricular acupuncture has on pain and anxiety scores, as well as on heart rate and blood pressure. Though the sample size is aimed to assess feasibility and will not be sufficiently powered for an efficacy analysis, if trends suggest that auricular acupuncture decreases pain and/or anxiety sores, further investigation with a larger randomized control trial will be warranted.
Eligible participants for this trial include Spanish or English speaking patients 18 years or older who are in early labor with a singleton pregnancy greater than or equal to 37+0 weeks gestation, and willing to be randomized to receive auricular acupuncture versus placebo. Early labor will be defined as less than 6 centimeters dilated and experiencing at least 2 contractions in ten minutes, per patient report and/or tocometry. Exclusion criteria include patients less than 18 years of age, non-Spanish or English-speaking patients, multi-gestation, preterm labor, greater than or equal to 6 cm dilated, less than 2 contractions in 10 minutes, morphine or nitrous oxide administration within the last two hours, congenital anomalies, open wounds or skin disorders of the ear, previous adverse reactions to acupuncture and/or allergies or contraindications to adhesives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a pilot study of a randomized control trial. Consented participants will be randomized to either auricular acupuncture or placebo intervention. Blood pressure, heart rate, and VAS pain and anxiety scores will be recorded and compared pre and post intervention in both treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupunture | Experimental | Device: Acupuncture Needle on an adhesiveParticipants randomized to this arm will undergo treatment with the 5 Needle Protocol of Auricular Acupuncture |
| Placebo | Placebo comparator | Device: AdhesivesParticipants randomized to this arm will undergo treatment with small adhesives without needles placed in the same configuration as the 5 Needle Protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older, Spanish or English speaking, with term (37+ weeks pregnant) singleton pregnancy, in early labor (as defined as less than 6cm dilated and having at least 2 contractions in 10 minutes)
Key exclusion criteria (1 listed)
- Younger than 18 years old, non-english or spanish speaking, greater than 6cm or not having consistent contractions (less than 2 contractions in 10 minutes), preterm and/or multiple gestation pregnancy, received morphine or nitrous oxide within the last 2 hours, congenital anomalies/wound/skin disorders of the ear, or prior adverse reaction to acupuncture, adverse reactions or allergies to adhesives.
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 |
|---|---|---|
| Acupuncture Needle on an adhesiveThis study utilizes acupuncture needs on small adhesives which will be placed according to the 5NP NADA Auricular Acupuncture Protocol. | Device | Auricular Acupunture |
| AdhesivesFor those randomized to the placebo arm, adhesives without needles will be placed according to the 5NP NADA Auricular Acupuncture Protocol placement | Device | Placebo |
Primary outcome
Percent of eligible participants that consent to being a part of the study
Time frame: up to 3 months
The investigators are evaluating if doing a randomized control trial on acupuncture in early labor is feasible in the setting of the Emergency Department of Women and Infants Hospital in Rhode Island by evaluating how many eligible patients consent to being a part of the study
Likert scale 1 to 5 of patient satisfaction with treatment experience
Time frame: up to 3 months
We are evaluating if doing acupuncture during labor is acceptable to patients in the emergency department of Women and Infants Hospital by using a Likert scale questionnaire evaluating their experience of receiving the intervention and their likelihood of doing the intervention were it to be offered again. The lowest value of the scale is 1 and the highest is 5. A higher number indicates higher level of satisfaction with the intervention performed.
2 secondary outcomes
Visual Analogue Scale pain score
Time frame: 30 minutes
Visual Analogue Scale Anxiety Scores
Time frame: 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 24906592Levett KM, Smith CA, Dahlen HG, Bensoussan A. Acupuncture and acupressure for pain management in labour and birth: a critical narrative review of current systematic review evidence. Complement Ther Med. 2014 Jun;22(3):523-40. doi: 10.1016/j.ctim.2014.03.011. Epub 2014 Apr 13.
- Background: PubMed 34489268Baumler P, Zhang W, Stubinger T, Irnich D. Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. BMJ Open. 2021 Sep 6;11(9):e045961. doi: 10.1136/bmjopen-2020-045961.
- Background: PubMed 24138333Zhang CS, Yang AW, Zhang AL, May BH, Xue CC. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. doi: 10.1089/acm.2013.0238. Epub 2013 Oct 19.
- Background: PubMed 34581941Vakilian K, Ghaemmaghami M, Sheikhganbari N, Shabani F, Vahedi M. Reducing Labor Anxiety with Auriculotherapy: A Randomized Clinical Trial Study. Chin J Integr Med. 2022 May;28(5):440-444. doi: 10.1007/s11655-021-3452-0. Epub 2021 Sep 28.
- Background: PubMed 32032444Smith CA, Collins CT, Levett KM, Armour M, Dahlen HG, Tan AL, Mesgarpour B. Acupuncture or acupressure for pain management during labour. Cochrane Database Syst Rev. 2020 Feb 7;2(2):CD009232. doi: 10.1002/14651858.CD009232.pub2.
- Background: PubMed 23929047King HC, Hickey AH, Connelly C. Auricular acupuncture: a brief introduction for military providers. Mil Med. 2013 Aug;178(8):867-74. doi: 10.7205/MILMED-D-13-00075.
- Background: PubMed 31146759Thomson G, Feeley C, Moran VH, Downe S, Oladapo OT. Women's experiences of pharmacological and non-pharmacological pain relief methods for labour and childbirth: a qualitative systematic review. Reprod Health. 2019 May 30;16(1):71. doi: 10.1186/s12978-019-0735-4.
- This is the website for the People's Organization of Community Acupuncture, this is the organization through which the key study personnel were trained in auricular acupunctureLink provided by the sponsor.
- Providence Community Acupuncture is the local organization that hosted the training and education for our key study personnel to learn auricular acupunctureLink provided by the sponsor.
- Individual participant dataSharing planned: No. As of now, this is a single site feasibility study. If we move forward with a larger multi-center study, we will plan to share IPD but at this time, given it is a single site and feasibility study we do not have a plan to share IPD with anyone other than the key study personnel.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Needle on an adhesive and Adhesives in people with Pain and Anxiety, run by Women and Infants Hospital of Rhode Island 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 1 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: finished, as of the sponsor's last update on 4 Apr 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of eligible participants that consent to being a part of the study (time frame: up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06678893, which also lists 7 linked publications.
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 4 Apr 2025.