RecoveryNCT04917614
Effect of Transcutaneous Electrical Acupoint Stimulation on Obstetric Quality of Recovery-10 After Cesarean Section
A study testing Transcutaneous Electrical Acupoint Stimulation in people with Recovery, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this prospective and randomized trial is to investigate the effect of TEAS on postoperative recovery using the Obstetric Quality of Recovery-10 questionnaire in patients undergoing elective cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recovery
- What is being tested?
- Transcutaneous Electrical Acupoint Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jul 2021to 24 Jan 2022
- 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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elective cesarean operation
- Able to give informed consent
Who cannot join
- Patients with neurological or psychological diseases
- patients with chronic analgesic and antidepressant drug use
- Patients unable to communicate
- Patients previously treated with TEAS or acupuncture,
- Patients with heart failure and have pace-maker,
- patient with local infection in the TEAS area
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this prospective and randomized trial is to investigate the effect of TEAS on postoperative recovery using the Obstetric Quality of Recovery-10 questionnaire in patients undergoing elective cesarean section.
Read the detailed description
Acupoint stimulation is postulated to modulate neurological signal transmission through afferent nociceptive pathways. Acupoint stimulation has been associated with positive effects on perioperative symptoms such as nausea, pain, and sleep disturbance. Transcutaneous electrical acupuncture point stimulation (TEAS) is an acupuncture treatment developed by combining traditional Chinese acupuncture with transcutaneous electrical nerve stimulation. TEAS has proven to be effective in postoperative pain and nausea-vomiting by applying a current of different frequencies, intensities, and waveforms through electrodes adhering to the skin. Using TEAS may relieve perioperative symptoms without increasing the risk of drug-related adverse events and alleviate and improve the patient's health condition, including the postoperative perspective.
- Conditions
- Recovery
- Being tested
- Transcutaneous Electrical Acupoint Stimulation
- Keywords
- ObsQoR-10T, recovery, ceserean, postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Acupoint StimulationDevice
Transcutaneous Electrical Acupoint Stimulation
| Study group | Role | What they receive |
|---|---|---|
| group teas | Active comparator | Patients in the TEAS group will receive preoperative TEAS for 30 min before the spinal anesthesia at Hegu (LI4), Neiguan (PC6), and Zusanli (St 36) with an electronic acupuncture device. Receives: Device: Transcutaneous Electrical Acupoint Stimulation |
| Control Group | Sham comparator | In the sham group, the patients were connected to the electronic acupuncture, but electronic stimulation was not applied. Receives: Device: Transcutaneous Electrical Acupoint Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
Measured: The first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start18 Jul 2021
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecoveryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Kozanhan, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917614
- Sponsor's protocol ID
- TEAS and ObsQoR-10
- Status last verified
- Sep 2024
- First submitted
- 2 Jun 2021
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Obstetric Quality of Recovery-10 After Cesarean Section
- ClinicalTrials.gov ID
- NCT04917614
- Acronym / sponsor ID
- TEAS and ObsQoR-10
- Conditions
- Recovery
- Keywords
- ObsQoR-10T, recovery, ceserean, postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 18 Jul 2021 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 8 Jun 2021 (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.
The primary aim of this prospective and randomized trial is to investigate the effect of TEAS on postoperative recovery using the Obstetric Quality of Recovery-10 questionnaire in patients undergoing elective cesarean section.
Detailed description
Acupoint stimulation is postulated to modulate neurological signal transmission through afferent nociceptive pathways. Acupoint stimulation has been associated with positive effects on perioperative symptoms such as nausea, pain, and sleep disturbance. Transcutaneous electrical acupuncture point stimulation (TEAS) is an acupuncture treatment developed by combining traditional Chinese acupuncture with transcutaneous electrical nerve stimulation. TEAS has proven to be effective in postoperative pain and nausea-vomiting by applying a current of different frequencies, intensities, and waveforms through electrodes adhering to the skin. Using TEAS may relieve perioperative symptoms without increasing the risk of drug-related adverse events and alleviate and improve the patient's health condition, including the postoperative perspective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group teas | Active comparator | Device: Transcutaneous Electrical Acupoint StimulationPatients in the TEAS group will receive preoperative TEAS for 30 min before the spinal anesthesia at Hegu (LI4), Neiguan (PC6), and Zusanli (St 36) with an electronic acupuncture device. |
| Control Group | Sham comparator | Device: Transcutaneous Electrical Acupoint StimulationIn the sham group, the patients were connected to the electronic acupuncture, but electronic stimulation was not applied. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Elective cesarean operation
- Able to give informed consent
Key exclusion criteria (6 listed)
- Patients with neurological or psychological diseases
- patients with chronic analgesic and antidepressant drug use
- Patients unable to communicate
- Patients previously treated with TEAS or acupuncture,
- Patients with heart failure and have pace-maker,
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 |
|---|---|---|
| Transcutaneous Electrical Acupoint StimulationTranscutaneous Electrical Acupoint Stimulation | Device | Control Group, group teas |
Primary outcome
Quality of Recovery
Time frame: The first 24 hours postoperatively
Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
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 25 Sep 2024.
- Individual participant dataSharing planned: No
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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 Transcutaneous Electrical Acupoint Stimulation in people with Recovery, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 25 Sep 2024. 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 Turkey (Türkiye). 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?
Quality of Recovery (time frame: The first 24 hours postoperatively). 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 25 Sep 2024.