Postoperative ComplicationsNCT02510183
P6 Acupressure Before Laparoscopic Cholecystectomy
A study testing Acupressure Wrist Band in people with Postoperative Complications and Postoperative Nausea and Vomiting, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
Trial summary
This study is to evaluate the effect of preoperative acupressure application on Postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy in terms of being in high risk group for PONV. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Complications, Postoperative Nausea and Vomiting
- What is being tested?
- Acupressure Wrist Band
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Apr 2016
- 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
- Patient undergoing elective laparoscopic cholecystectomy
- Patients who make their admission the day before surgery
- Patients with American Society of Anesthesiologists (ASA) physical status classification system I and II
- Patient who gave written consent to participate in the study
Who cannot join
- Patient who undergone urgent laparoscopic cholecystectomy
- Patients who make their admission on the day of surgery
- Patients with who do not conform physical status of ASA I and II
- Patients who loss single or both upper extremity
- Patients with open wounds, scar tissue or infection on wrist in acupressure application area
About this study
Official title: Evaluation of the Effects of P6 Acupressure Application on Postoperative Nausea and Vomiting Before Laparoscopic Cholecystectomy
This study is to evaluate the effect of preoperative acupressure application on Postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy in terms of being in high risk group for PONV.
Read the detailed description
Prevention of postoperative complications is one of the main tasks of nurses. However, there are limited nursing interventions that can be done to prevent PONV. The American Society of PeriAnesthesia Nurses suggest nurses to teach patients with a high risk of PONV about acupressure application on P6 acupoint or to apply acupressure wristbands preoperatively. However this suggestion has a low evidence.
- Being tested
- Acupressure Wrist Band, Placebo Acupressure Wrist Band
- Keywords
- Acupressure, Perioperative Care, Postoperative Nausea and Vomiting, Nursing Care Management
- Medical subject headings
- Postoperative Complications, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure Wrist BandDevice
Also called Sea Band
Acupressure wrist band is a knitted elasticated wrist band, which operates by applying pressure on the P6 acupressure point on each wrist by means of a plastic stud.
Placebo Acupressure Wrist BandDevice
Placebo Acupressure Wrist Band is a knitted elasticated wrist band without a plastic stud.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Wrist Band | Active comparator | Patient receive preoperative education a day before surgery, education for acupressure application on the day of surgery, an acupressure wrist band is applied on P6 acupoint in both wrist an hour before surgery Receives: Device: Acupressure Wrist Band |
| Placebo Wrist Band | Placebo comparator | Patient receive preoperative education a day before surgery, an placebo acupressure wrist band is applied in both wrist an hour before surgery Receives: Device: Placebo Acupressure Wrist Band |
| Control Grup Without Band | No intervention | Patient receive preoperative education a day before surgery, and patient are only visited an hour before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acupressure affect on Postoperative Nausea, Vomiting and medication need
Postoperative nausea, vomiting and medication need are assessed on 2nd, 6th and 24th hours postoperative. Nausea severity measured by 0-10 scoring (0- no nausea,10- nausea as bad as can be), and vomiting is assessed as episodes. Number of antiemetics and analgesics medications that are given (out of routine therapy) are also evaluated.
Measured: 24 hours postoperatively
Secondary outcomes (2)
Pain
Pain measured by 0-10 scoring (0- no pain,10- pain as bad as can be) on 2nd, 6th and 24th hours postoperative.
Measured: 24 hours postoperatively
Perioperative Stress
Perioperative Stress measured by State-Trait Anxiety Inventory (STAI) score on day before surgery and day after surgery
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emine Iyigun, Assoc.Prof., Study chair, Gulhane Military Medical Academy, School of Nursing, Department of Surgical NursingMehmet F CAN, Assoc.Prof., Study chair, Gulhane Military Medical Academy, Department of General SurgerySibel Yilmaz Sahin, PhDs, Principal investigator, Gulhane Military Medical Academy, School of Nursing, Department of Surgical Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510183
- Sponsor's protocol ID
- GulhaneMMA
- Status last verified
- Jun 2015
- First submitted
- 28 Jun 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Adib-Hajbaghery M, Etri M, Hosseainian M, Mousavi MS. Pressure to the p6 acupoint and post-appendectomy pain, nausea, and vomiting: a randomized clinical trial. J Caring Sci. 2013 Jun 1;2(2):115-22. doi: 10.5681/jcs.2013.014. eCollection 2013 Jun.
PubMed 25276717Agarwal A, Bose N, Gaur A, Singh U, Gupta MK, Singh D. Acupressure and ondansetron for postoperative nausea and vomiting after laparoscopic cholecystectomy. Can J Anaesth. 2002 Jun-Jul;49(6):554-60. doi: 10.1007/BF03017380.
PubMed 12067865American Society of PeriAnesthesia Nurses PONV/PDNV Strategic Work Team. ASPAN'S evidence-based clinical practice guideline for the prevention and/or management of PONV/PDNV. J Perianesth Nurs. 2006 Aug;21(4):230-50. doi: 10.1016/j.jopan.2006.06.003. No abstract available.
PubMed 16935735Hickman AG, Bell DM, Preston JC. Acupressure and postoperative nausea and vomiting. AANA J. 2005 Oct;73(5):379-85.
PubMed 16261854Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003281. doi: 10.1002/14651858.CD003281.pub3.
PubMed 19370583Sadati L, Pazouki A, Mehdizadeh A, Shoar S, Tamannaie Z, Chaichian S. Effect of preoperative nursing visit on preoperative anxiety and postoperative complications in candidates for laparoscopic cholecystectomy: a randomized clinical trial. Scand J Caring Sci. 2013 Dec;27(4):994-8. doi: 10.1111/scs.12022. Epub 2013 Jan 28.
PubMed 23350886
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of P6 Acupressure Application on Postoperative Nausea and Vomiting Before Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02510183
- Acronym / sponsor ID
- GulhaneMMA
- Keywords
- Acupressure, Perioperative Care, Postoperative Nausea and Vomiting, Nursing Care Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 29 Jul 2015 (estimated)
- 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 study is to evaluate the effect of preoperative acupressure application on Postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy in terms of being in high risk group for PONV.
Detailed description
Prevention of postoperative complications is one of the main tasks of nurses. However, there are limited nursing interventions that can be done to prevent PONV. The American Society of PeriAnesthesia Nurses suggest nurses to teach patients with a high risk of PONV about acupressure application on P6 acupoint or to apply acupressure wristbands preoperatively. However this suggestion has a low evidence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupressure Wrist Band | Active comparator | Device: Acupressure Wrist BandPatient receive preoperative education a day before surgery, education for acupressure application on the day of surgery, an acupressure wrist band is applied on P6 acupoint in both wrist an hour before surgery |
| Placebo Wrist Band | Placebo comparator | Device: Placebo Acupressure Wrist BandPatient receive preoperative education a day before surgery, an placebo acupressure wrist band is applied in both wrist an hour before surgery |
| Control Grup Without Band | No intervention | –Patient receive preoperative education a day before surgery, and patient are only visited an hour before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient undergoing elective laparoscopic cholecystectomy
- Patients who make their admission the day before surgery
- Patients with American Society of Anesthesiologists (ASA) physical status classification system I and II
- Patient who gave written consent to participate in the study
Key exclusion criteria (5 listed)
- Patient who undergone urgent laparoscopic cholecystectomy
- Patients who make their admission on the day of surgery
- Patients with who do not conform physical status of ASA I and II
- Patients who loss single or both upper extremity
- Patients with open wounds, scar tissue or infection on wrist in acupressure application area
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 |
|---|---|---|
| Acupressure Wrist BandAlso: Sea BandAcupressure wrist band is a knitted elasticated wrist band, which operates by applying pressure on the P6 acupressure point on each wrist by means of a plastic stud. | Device | Acupressure Wrist Band |
| Placebo Acupressure Wrist BandPlacebo Acupressure Wrist Band is a knitted elasticated wrist band without a plastic stud. | Device | Placebo Wrist Band |
Primary outcome
Acupressure affect on Postoperative Nausea, Vomiting and medication need
Time frame: 24 hours postoperatively
Postoperative nausea, vomiting and medication need are assessed on 2nd, 6th and 24th hours postoperative. Nausea severity measured by 0-10 scoring (0- no nausea,10- nausea as bad as can be), and vomiting is assessed as episodes. Number of antiemetics and analgesics medications that are given (out of routine therapy) are also evaluated.
2 secondary outcomes
Pain
Time frame: 24 hours postoperatively
Perioperative Stress
Time frame: 48 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Background: PubMed 25276717Adib-Hajbaghery M, Etri M, Hosseainian M, Mousavi MS. Pressure to the p6 acupoint and post-appendectomy pain, nausea, and vomiting: a randomized clinical trial. J Caring Sci. 2013 Jun 1;2(2):115-22. doi: 10.5681/jcs.2013.014. eCollection 2013 Jun.
- Background: PubMed 12067865Agarwal A, Bose N, Gaur A, Singh U, Gupta MK, Singh D. Acupressure and ondansetron for postoperative nausea and vomiting after laparoscopic cholecystectomy. Can J Anaesth. 2002 Jun-Jul;49(6):554-60. doi: 10.1007/BF03017380.
- Background: PubMed 16935735American Society of PeriAnesthesia Nurses PONV/PDNV Strategic Work Team. ASPAN'S evidence-based clinical practice guideline for the prevention and/or management of PONV/PDNV. J Perianesth Nurs. 2006 Aug;21(4):230-50. doi: 10.1016/j.jopan.2006.06.003. No abstract available.
- Background: PubMed 16261854Hickman AG, Bell DM, Preston JC. Acupressure and postoperative nausea and vomiting. AANA J. 2005 Oct;73(5):379-85.
- Background: PubMed 19370583Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003281. doi: 10.1002/14651858.CD003281.pub3.
- Background: PubMed 23350886Sadati L, Pazouki A, Mehdizadeh A, Shoar S, Tamannaie Z, Chaichian S. Effect of preoperative nursing visit on preoperative anxiety and postoperative complications in candidates for laparoscopic cholecystectomy: a randomized clinical trial. Scand J Caring Sci. 2013 Dec;27(4):994-8. doi: 10.1111/scs.12022. Epub 2013 Jan 28.
Related trials for Postoperative Complications
Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Not yet recruiting
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
Infection, Surgical Site
RecruitingPhase 4
Acetaminophen-Mannitol Injection and Postoperative Delirium
Postoperative Delirium
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.
Emine Iyigun, Assoc.Prof. study chair
Gulhane Military Medical Academy, School of Nursing, Department of Surgical Nursing
Mehmet F CAN, Assoc.Prof. study chair
Gulhane Military Medical Academy, Department of General Surgery
Sibel Yilmaz Sahin, PhDs principal investigator
Gulhane Military Medical Academy, School of Nursing, Department of Surgical Nursing
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure Wrist Band in people with Postoperative Complications and Postoperative Nausea and Vomiting, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Acupressure affect on Postoperative Nausea, Vomiting and medication need (time frame: 24 hours postoperatively). 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 NCT02510183, which also lists 6 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 29 Jul 2015.