Postoperative NauseaPhase 2AcunauseaNCT01389570
Postoperative Nausea/Vomiting and Acupressure
A Phase 2 study testing Acupressure wrist band in people with Postoperative Nausea, run by National Research Centre of Complementary and Alternative Medicine, Norway at 1 site in Norway.
Trial summary
Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice. However, pharmaceutical prophylaxis can confer unpleasant adverse effects. It would therefore be appropriate to consider the use of non-pharmacological methods in preventing PONV. Read more about this study
- Who is it for?
- Ages 1 year to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea
- What is being tested?
- Acupressure wrist band
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2011to Jun 2012
- Phase
- Phase 2
- 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 1 year to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults undergoing orthopaedic, general, and ear, nose, throat surgery at Lovisenberg Diaconal Hospital
Who cannot join
- Not fully verbal communication or informed consent not achieved
Trial locations and contacts
1 site in 1 country.
Norway1 site
Lovisenberg Diaconal Hospital
Oslo
Michael Howley, MD, + 47 23 22 64 29, michael.howley@lds.no
Arne Johan Norheim, PhD, +4748005535, arne.johan.norheim@hlkbb.no
About this study
Official title: Postoperative Nausea/Vomiting and Acupressure Can Acupressure With Wristbands Reduce the Use of Antiemetics for the Treatment of Postoperative Nausea and Vomiting?
Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice. However, pharmaceutical prophylaxis can confer unpleasant adverse effects. It would therefore be appropriate to consider the use of non-pharmacological methods in preventing PONV. Acupuncture and acupressure are reported to be effective preventive treatment for PONV, and the adverse effects are minimal. Consequently, the aim of the study is to implement acupressure in our anaesthetic department procedures. A reduction of the use of antiemetics will be a parameter on the effectiveness of acupressure. The study will focus on acupressure as a supplement to the ordinary prophylactic treatment of PONV in adults undergoing orthopaedic and general surgery, and adults and children undergoing ear, nose, throat surgery. The primary endpoints are the quantities of antiemetics used before (baseline) and during the implementation period. The study will be conducted from January to December 2011.
Read the detailed description
Background:
Nausea and vomiting after surgery and anaesthesia are inconvenient and undesirable physiological and psychological events. In addition to causing distress and discomfort for the patient, retching and vomiting can increase the risk of pain and bleeding, resultant resource use, and prolong stay at the postoperative ward and hospital. The mechanisms behind Postoperative nausea and vomiting (PONV) are complicated, and many of the trigger factors are still unknown. Several types of pharmaceutical antiemetics are in use, but drug therapy is only partially effective in preventing or treating PONV. In 2008 we conducted a trial to assess the effectiveness of acupuncture and acupressure (acustimulation) in reducing postoperative retching and vomiting in children undergoing tonsillectomy and/or adenoidectomy. The results were promising, and the article is published in Acupuncture in Medicine in March 2011.
Acustimulation:
Cochrane systematic reviews show the effect of acupuncture and acupressure in postoperative antiemetic treatment. The reviews show no clear difference in the effectiveness of P6 acupoint stimulation for adults and children, or for invasive and non-invasive acupoint stimulation. Moreover, there was no reliable evidence for differences in risks of postoperative nausea or vomiting after P6 acupoint stimulation compared to antiemetic drugs.
Aim and objective:
Acupressure wrist bands are less expensive compared to most antiemetics, and the adverse effects of acupoint stimulation are minimal. Accordingly, a reduction in cost-benefit by the use of wristband, is apparent. Considering the results from earlier research along with the promising results from our trial, we are encouraged to implement acupressure into our standard anaesthetic procedures. A reduction of the use of antiemetics will be a parameter on the effectiveness of acupressure.
The aim of this quality improvement study is to implement acupressure as a supplement to the ordinary prophylactic treatment of PONV in our hospital. The objective is to observe whether use of acupressure wristbands reduces the consumption of antiemetics for the treatment of postoperative nausea and vomiting.
- Conditions
- Postoperative Nausea
- Being tested
- Acupressure wrist band
- Medical subject headings
- 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 bandProcedure or surgery
Also called Sea-Band Ltd
Use of acupressure wristband during surgery Manufacturer; Pinnacle Ind Ltd, Rm 831 Thriving Ind Ctr, 26-38 Sha Tsui Rd, Tsuen Wan, Hong Kong
| Study group | Role | What they receive |
|---|---|---|
| Acupressure wrist band | Experimental | The group receiving acupressure wrist band Receives: Procedure: Acupressure wrist band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of acupressure for postoperative nausea in terms of less use of antiemetic drugs
Study the effectiveness of acupressure for nausea in all surgical patients undergoing surgery at the Lovisenberg Diakonale hospital.
Effectiveness is monitored by the use of antiemetic drugs compared to a similar period before the wristbands were introduced as standard care at the hospital.
Measured: one year
Secondary outcomes (1)
Reduction in use of antiemetic medication as a consequence of the introduction of acupressure wristband
The study will be conducted with a one-group pretest-posttest design, measuring the consumption of antiemetics during a three month period before the implementation (baseline), and during the implementation period. The numbers of surgical operations will be the denominator in the two fractions.
This secondary outcome might also be regarded as the primary outcome as the amount of antinausea medication is the major outcome measure
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative NauseaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre of Complementary and Alternative Medicine, Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital
- Investigators
- Arne Johan Norheim, PhD, Principal investigator, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389570
- Sponsor's protocol ID
- 2011/176
- Acronym
- Acunausea
- Status last verified
- Jun 2011
- First submitted
- 31 May 2011
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Nausea/Vomiting and Acupressure Can Acupressure With Wristbands Reduce the Use of Antiemetics for the Treatment of Postoperative Nausea and Vomiting?
- ClinicalTrials.gov ID
- NCT01389570
- Acronym / sponsor ID
- Acunausea / 2011/176
- Conditions
- Postoperative Nausea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Research Centre of Complementary and Alternative Medicine, NorwayUniversity, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 8 Jul 2011 (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.
Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice. However, pharmaceutical prophylaxis can confer unpleasant adverse effects. It would therefore be appropriate to consider the use of non-pharmacological methods in preventing PONV. Acupuncture and acupressure are reported to be effective preventive treatment for PONV, and the adverse effects are minimal. Consequently, the aim of the study is to implement acupressure in our anaesthetic department procedures. A reduction of the use of antiemetics will be a parameter on the effectiveness of acupressure. The study will focus on acupressure as a supplement to the ordinary prophylactic treatment of PONV in adults undergoing orthopaedic and general surgery, and adults and children undergoing ear, nose, throat surgery. The primary endpoints are the quantities of antiemetics used before (baseline) and during the implementation period. The study will be conducted from January to December 2011.
Detailed description
Background:
Nausea and vomiting after surgery and anaesthesia are inconvenient and undesirable physiological and psychological events. In addition to causing distress and discomfort for the patient, retching and vomiting can increase the risk of pain and bleeding, resultant resource use, and prolong stay at the postoperative ward and hospital. The mechanisms behind Postoperative nausea and vomiting (PONV) are complicated, and many of the trigger factors are still unknown. Several types of pharmaceutical antiemetics are in use, but drug therapy is only partially effective in preventing or treating PONV. In 2008 we conducted a trial to assess the effectiveness of acupuncture and acupressure (acustimulation) in reducing postoperative retching and vomiting in children undergoing tonsillectomy and/or adenoidectomy. The results were promising, and the article is published in Acupuncture in Medicine in March 2011.
Acustimulation:
Cochrane systematic reviews show the effect of acupuncture and acupressure in postoperative antiemetic treatment. The reviews show no clear difference in the effectiveness of P6 acupoint stimulation for adults and children, or for invasive and non-invasive acupoint stimulation. Moreover, there was no reliable evidence for differences in risks of postoperative nausea or vomiting after P6 acupoint stimulation compared to antiemetic drugs.
Aim and objective:
Acupressure wrist bands are less expensive compared to most antiemetics, and the adverse effects of acupoint stimulation are minimal. Accordingly, a reduction in cost-benefit by the use of wristband, is apparent. Considering the results from earlier research along with the promising results from our trial, we are encouraged to implement acupressure into our standard anaesthetic procedures. A reduction of the use of antiemetics will be a parameter on the effectiveness of acupressure.
The aim of this quality improvement study is to implement acupressure as a supplement to the ordinary prophylactic treatment of PONV in our hospital. The objective is to observe whether use of acupressure wristbands reduces the consumption of antiemetics for the treatment of postoperative nausea and vomiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupressure wrist band | Experimental | Procedure: Acupressure wrist bandThe group receiving acupressure wrist band |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults undergoing orthopaedic, general, and ear, nose, throat surgery at Lovisenberg Diaconal Hospital
Key exclusion criteria (1 listed)
- Not fully verbal communication or informed consent not achieved
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-Band LtdUse of acupressure wristband during surgery Manufacturer; Pinnacle Ind Ltd, Rm 831 Thriving Ind Ctr, 26-38 Sha Tsui Rd, Tsuen Wan, Hong Kong | Procedure or surgery | Acupressure wrist band |
Primary outcome
Effectiveness of acupressure for postoperative nausea in terms of less use of antiemetic drugs
Time frame: one year
Study the effectiveness of acupressure for nausea in all surgical patients undergoing surgery at the Lovisenberg Diakonale hospital. Effectiveness is monitored by the use of antiemetic drugs compared to a similar period before the wristbands were introduced as standard care at the hospital.
1 secondary outcome
Reduction in use of antiemetic medication as a consequence of the introduction of acupressure wristband
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2011.
Related trials for Postoperative Nausea
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
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Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
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Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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.
Arne Johan Norheim, PhD principal investigator
University of Tromso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupressure wrist band in people with Postoperative Nausea, run by National Research Centre of Complementary and Alternative Medicine, Norway at 1 site in Norway.
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: status not confirmed, as of the sponsor's last update on 18 Jul 2011. 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 Norway. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Michael Howley, MD (+ 47 23 22 64 29, michael.howley@lds.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of acupressure for postoperative nausea in terms of less use of antiemetic drugs (time frame: one year). 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 18 Jul 2011.