Role of Emotional Freedom Techniques in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Information source: Benazir Bhutto Hospital, Rawalpindi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Nausea and Vomiting
Intervention: EFTs (emotional freedom techniques) (Behavioral); Tab. Midazolam 7.5 mg (Drug); Inj. Midazolam 0.7mg/kg (Drug); Inj. Propofol 2.5mg/kg (Drug); Inj. Atracurium 0.5 mg/kg (Drug); Sevoflurane 2.5 vol % (Drug); Inj. Cefuroxime 1.5 g IV (Drug); Drug: Inj. Ketorolac 30 mg IV (Drug); Inj. Zantac 50mg IV (Drug)
Phase: N/A
Status: Completed
Sponsored by: Benazir Bhutto Hospital, Rawalpindi Official(s) and/or principal investigator(s): Fazal H Shah, FCPS I, Principal Investigator, Affiliation: Benazir Bhutto Hospital, Rawalpindi Aurangzeb Khan, FCPS, Study Chair, Affiliation: Benazir Bhutto Hospital, Rawalpindi Jahangir S Khan, FCPS, FACS, Study Chair, Affiliation: Benazir Bhutto Hospital, Rawalpindi Muhammad B Habshi, FCPS I, Study Chair, Affiliation: Benazir Bhutto Hospital, Rawalpindi Muhammad Z Saeed, FCPS I, Study Chair, Affiliation: Benazir Bhutto Hospital, Rawalpindi Sheikh F Riaz, FCPS I, Study Chair, Affiliation: Benazir Bhutto Hospital, Rawalpindi
Summary
In our study the investigators want to evaluate the effects of EFTs (emotional freedom
techniques) for reducing incidence of PONV (Postoperative nausea and vomiting). The effects
of EFTs have been quiet evident on many aspects if the incidence of PONV is reduced then it
will be much valuable adjunct to postoperative management of the patients.
Our hypothesis was Emotional freedom techniques are very useful to reduce the incidence of
postoperative nausea and vomiting after laparoscopic cholecystectomy.
Clinical Details
Official title: A Randomized Controlled Trial: Role of EFTs (Emotional Freedom Techniques) in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Postoperative nausea and vomiting.Rescue antiemetic
Detailed description:
The laparoscopic cholecystectomy is now considered as the gold standard for gall stone
disease worldwide and over 90% of cholecystectomies are now performed laparoscopically. Due
to variety of factors, postoperative nausea and vomiting (PONV) which occurs in 40-70 % of
patients undergoing laparoscopic cholecystectomy (LC) is sometimes much troublesome to
manage. To reduce the incidence of PONV many drugs and modifications were introduced, such
as use of dexamethasone, serotonin receptor antagonists, changing drugs and dosages during
anesthesia and acupressure. All these measures except acupressure have some degree of side
effects on patients.
The Emotional Freedom Techniques (EFTs) which has been pioneered by Gary Craig is a form of
alternate medicine which works by tapping on body energy meridian points. Unlike drugs the
EFTs has no side effects too. The role of EFTs for various kinds of physical and mental
problems has been established and has shown quite significant results. Initially EFTs were
used for psychological benefits but later on research proved that it works on the physical
and biochemical levels too which is comparable to the various drugs which act by biochemical
changes on human body.
In our study we want to evaluate the effects of EFTs for reducing incidence of PONV. The
effects of EFTs have been quiet evident on many aspects if the incidence of PONV is reduced
then it will be much valuable adjunct to postoperative management of the patients. We have
taken into the consideration of PONV only and after promising results we can evaluate EFTs
on more and more other aspects of patient management After meeting inclusion and exclusion
criteria, All patients were given Tab. Midazolam 7. 5 mg PO at night before surgery and
received same standard general anesthesia with endotracheal intubation. Inj. Midazolam IV
0. 7 mg/kg was given 45 min before surgery as premedication. Anesthesia was induced by
propofol (2. 5 mg/kg) after 3 minutes of preoxygenation. Muscle relaxation was achieved by
atracuium (0. 5 mg/kg). Anesthesia was maintained with sevoflurane (2. 5 vol %) and oxygen in
air mixture (0. 50 ratio). Ventilation was controlled mechanically and end tidal normocapnia
was maintained by keeping pCO2 at 35-38 mmHg.
Following medications were given to patients during the process.
- Inj. Cefuroxime 1. 5 gm. IV (2 doses, 1st dose 30-60 min before surgery and 2nd dose 6
hours after surgery)
- Inj. Ketorolac 30mg IV (3 doses total, 1st dose immediate postop, 2nd and 3rd at 8 and
16 hours after surgery respectively)
- Inj. Zantac 50 mg IV (2 doses total, 1st immediate postop and 2nd at 12 hours after
surgery) All patients were operated by the consultant surgeons. After surgery ward all
patients received same standard postoperative care. At 6 hour postoperative period all
patients were assessed for PONV by VDS. Then patients were divided randomly into two
groups equally by consecutive non probability sampling. Group A was control group while
Group B received one session of EFTs tapping for 5 to 10 min. All patients were
assessed by PONV at 7, 10 and 15 hours postoperatively. Rescue antiemetic (inj.
Metoclopramide 10mg IV) was used when the score of PONV was 2 or more on VDS. To see
the effectiveness of EFTs in study group the no. of injections of metoclopramide were
not counted at 6 hour postoperatively i. e. before intervention of EFTs.
All the data was recorded on specially designed Performa. Statistical analysis: Data was
analyzed using SPSS version 12. Mean and standard deviation were calculated for quantitative
data like age, frequency of antiemetic injections. Frequency and percentages were calculated
for qualitative data like gender, PONV on the basis of VDS scale. The results were finally
analyzed and compared for the two groups using Chi-square test and Mann Whitney U tests
where applicable. A p value <0. 05 was considered significant.
Eligibility
Minimum age: 25 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients undergoing elective laparoscopic cholecystectomy for gallstone disease.
2. Patients with age range of 25 to 55 years
Exclusion Criteria:
1. H/O chronic illness like DM, IHD, CRF, CLD,
2. H/O acute or chronic psychiatric or psychological illness.
3. H/O APD (acid peptic disease) or regurgitation.
4. H/O of any chemotherapy (cancer drugs, opioids), radiotherapy, any history of
repeated infection.
5. H/O use of hepatotoxic drugs like acetaminophen, ciprofloxacin, ATT, valproic acid
etc. in last one month.
6. H/O alcohol intake in last one month.
7. Previous hepatobilliary surgery.
8. Complicated cholecystectomy in which laparoscopic cholecystectomy is converted to
open cholecystectomy.
9. Patients who are given opioids in postoperative period.
10. Patients who need epidural analgesia in postoperative period.
Locations and Contacts
Benazir Bhutto Hospital Rawalpindi., Rawalpindi, Punjab 46000, Pakistan
Additional Information
EFTs manual
Related publications: Eryılmaz HB, Memiş D, Sezer A, Inal MT. The effects of different insufflation pressures on liver functions assessed with LiMON on patients undergoing laparoscopic cholecystectomy. ScientificWorldJournal. 2012;2012:172575. doi: 10.1100/2012/172575. Epub 2012 Apr 24. Feng PH, Chu KS, Lu IC, Shieh JP, Tzeng JI, Ho ST, Wang JJ, Chu CC. Haloperidol plus ondansetron prevents postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. Acta Anaesthesiol Taiwan. 2009 Mar;47(1):3-9. doi: 10.1016/S1875-4597(09)60013-8. Bianchin A, De Luca A, Caminiti A. Postoperative vomiting reduction after laparoscopic cholecystectomy with single dose of dexamethasone. Minerva Anestesiol. 2007 Jun;73(6):343-6. Craig G. The EFT Manual. Available from: http://www.spiritual-web.com/downloads/eftmanual.pdf Church D, De Asis MA, Brooks AJ. Brief group intervention using emotional freedom techniques for depression in college students: a randomized controlled trial. Depress Res Treat. 2012;2012:257172. doi: 10.1155/2012/257172. Epub 2012 Jul 17. Church D, Hawk C, Brooks AJ, Toukolehto O, Wren M, Dinter I, Stein P. Psychological trauma symptom improvement in veterans using emotional freedom techniques: a randomized controlled trial. J Nerv Ment Dis. 2013 Feb;201(2):153-60. doi: 10.1097/NMD.0b013e31827f6351. Church D, Yount G, Brooks AJ. The effect of emotional freedom techniques on stress biochemistry: a randomized controlled trial. J Nerv Ment Dis. 2012 Oct;200(10):891-6. doi: 10.1097/NMD.0b013e31826b9fc1. Stapleton P, Church D, Sheldon T, Porter B, Carlopio C. Depression symptoms improve after successful weight loss with emotional freedom techniques. ISRN Psychiatry. 2013 Jul 28;2013:573532. doi: 10.1155/2013/573532. eCollection 2013.
Starting date: July 2013
Last updated: June 19, 2014
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