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Completed

NCT Number: NCT02169856

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

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.

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benazir Bhutto Hospital Rawalpindi.

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing elective laparoscopic cholecystectomy for gallstone disease.
  • Patients with age range of 25 to 55 years

Exclusion criteria

  • H/O chronic illness like DM, IHD, CRF, CLD,
  • H/O acute or chronic psychiatric or psychological illness.
  • H/O APD (acid peptic disease) or regurgitation.
  • H/O of any chemotherapy (cancer drugs, opioids), radiotherapy, any history of repeated infection.
  • H/O use of hepatotoxic drugs like acetaminophen, ciprofloxacin, ATT, valproic acid etc. in last one month.
  • H/O alcohol intake in last one month.
  • Previous hepatobilliary surgery.
  • Complicated cholecystectomy in which laparoscopic cholecystectomy is converted to open cholecystectomy.
  • Patients who are given opioids in postoperative period.
  • Patients who need epidural analgesia in postoperative period.

Treatment and study plan

EFTs (emotional freedom techniques)

Behavioral

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

Other names: EFTs by garry craig

Tab. Midazolam 7.5 mg

Drug

Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.

Other names: Tab. Doramicum

Inj. Midazolam 0.7mg/kg

Drug

Inj . Midazolam 0.7 mg/kg given as premedication 45 min before surgery.

Other names: inj. Doramicum

Inj. Propofol 2.5mg/kg

Drug

It was given to induce anesthesia after 3 min of pre oxygenation.

Inj. Atracurium 0.5 mg/kg

Drug

It was given to induce muscle relaxation during anesthesia

Sevoflurane 2.5 vol %

Drug

It was given to maintain anesthesia during surgery alongwith oxygen in air mixture

Inj. Cefuroxime 1.5 g IV

Drug

It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery

Other names: inj. zinacef

Drug: Inj. Ketorolac 30 mg IV

Drug

3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period

Inj. Zantac 50mg IV

Drug

2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery

Primary outcomes

  1. Postoperative nausea and vomiting.

    Time frame: will be measured at upto 15 hours postoperatively.

    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
  2. Rescue antiemetic

    Time frame: It will be measured upto 15 hours postoperatively.

    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).

Other outcomes

  1. age

    Time frame: age of the patient at study time in years. average was 30 years approximately.

    age of the patient

Sponsors and collaborators

Lead sponsor

Benazir Bhutto Hospital, Rawalpindi

Other Gov

Registry information

Official study title

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

Acronym: EFT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 23, 2014
Registry last updated
Jun 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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