Role of Emotional Freedom Techniques in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Postoperative Nausea and Vomiting Clinical Trial

— EFT  

Official title:

A Randomized Controlled Trial: Role of EFTs (Emotional Freedom Techniques) in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169856
• Other study ID #: 02
• Status: Completed
• Phase: N/A
• First received: June 9, 2014
• Last updated: June 19, 2014
• Start date: July 2013
• Est. completion date: February 2014

Study information

• Verified date: June 2014
• Source: Benazir Bhutto Hospital, Rawalpindi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Behavioral:
• EFTs (emotional freedom techniques)
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

Drug:
• Tab. Midazolam 7.5 mg
Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.
• Inj. Midazolam 0.7mg/kg
Inj . Midazolam 0.7 mg/kg given as premedication 45 min before surgery.
• Inj. Propofol 2.5mg/kg
It was given to induce anesthesia after 3 min of pre oxygenation.
• Inj. Atracurium 0.5 mg/kg
It was given to induce muscle relaxation during anesthesia
• Sevoflurane 2.5 vol %
It was given to maintain anesthesia during surgery alongwith oxygen in air mixture
• Inj. Cefuroxime 1.5 g IV
It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery
• Drug: Inj. Ketorolac 30 mg IV
3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period
• Inj. Zantac 50mg IV
2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery

Locations

Country	Name	City	State
Pakistan	Benazir Bhutto Hospital Rawalpindi.	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Benazir Bhutto Hospital, Rawalpindi

Country where clinical trial is conducted

Pakistan, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Craig G. The EFT Manual. Available from: http://www.spiritual-web.com/downloads/eftmanual.pdf

Eryilmaz HB, Memis 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	age	age of the patient	age of the patient at study time in years. average was 30 years approximately.	No
Primary	Postoperative nausea and vomiting.	Both groups will be assessed for postoperative nausea/vomiting by VDS (verbal descriptive scale) at 6, 7, 10 and 15 hours respectively.; Verbal descriptive Scale 0 No nausea; Mild nausea; Moderate nausea; Frequent vomiting; Severe vomiting	will be measured at upto 15 hours postoperatively.	No
Primary	Rescue antiemetic	Both groups will receive rescue antiemetic i.e. inj. Metoclopramide 10mg IV when there will be 2 or more score on VDS (verbal descriptive scale).	It will be measured upto 15 hours postoperatively.	No

External Links

•   EFTs manual