| CTRI Number |
CTRI/2015/07/005959 [Registered on: 02/07/2015] Trial Registered Prospectively |
| Last Modified On: |
03/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of emotional freedom techniques tapping on anxiety among women undergoing obstetrics and gynecological surgeries |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of emotional freedom techniques(E.F.T) tapping on anxiety among women undergoing obstetrics and gynecological surgeries in a selected hospital,Mangalore |
| Trial Acronym |
EFT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rosa M TSr Rosaline Thomas |
| Designation |
Post Graduate Student |
| Affiliation |
Father Muller Charitable Institutions |
| Address |
Sellere Malaparamba
Calicut
Kerala
Sellere Malaparamba
Calicut
Kerala
Kozhikode
KERALA
673009
India |
| Phone |
9620321330 |
| Fax |
|
| Email |
rosetomc30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Savitha Pramilda Cutinho |
| Designation |
Professor & HOD OBG Nursing |
| Affiliation |
Father Muller Charitable Institutions |
| Address |
Father Muller College Of Nursing
FMCI
Kankanady
Mangaluru
Father Muller College Of Nursing
FMCI
Kankanady
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9740687444 |
| Fax |
|
| Email |
savithacutinho@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Darryl MS Aranha |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Charitable Institutions |
| Address |
Father Muller College Of Nursing
FMCI
Kankanady
Mangaluru
Father Muller College Of Nursing
FMCI
Kankanady
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9481346802 |
| Fax |
|
| Email |
aranhadarryl@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rosa M T |
| Address |
Rosa M T
Sellere Malaparamba House
Calicut
Kerala
673009 |
| Type of Sponsor |
Other [Self Financed] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Darryl MS Aranha |
Father Muller Medical College Hospital |
G & H Unit
Obstetrics & Gynaec Ward
Father Muller Medical College Hospital
FMCI
Kankanady
Mangaluru
Dakshina Kannada
KARNATAKA |
9481346802
aranhadarryl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Women admited in hospital to undergo obstetrical and gynaecological surgeries with selected conditions obstructed labour,cefalo pelvic disproportions,uterine fibroids and uterine prolapse, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Emotional freedom techniques |
Gr I control group Pre surgery Medicatuion Tablet Rantac 150mg & perinorm 10mg |
| Intervention |
Emotional Freedom Techniques(EFT) |
Emotional Freedom Techniques (EFT) is a new and emerging complementary therapy for eliminating emotional and physical problems by re-balancing the energy system of the body based on one simple paradigm-shift: “The cause of all negative emotions is a disruption in the body’s energy systemâ€. The investigator gently taps on traditional acupressure points on the face, the upper body and the hands, with fingertips while the subject thinks about the specific problem and voicing positive affirmations. The Setup...Repeat 3 times this affirmation:
"Even though I have this anxiety , I deeply and completely accept myself."
While continuously rubbing the Sore Spot or tapping the Karate Chop point.
Karate chop point is located at the center of the fleshy part of the outside of the hand between the top of the wrist and base of the baby finger.
2. The Sequence...Tap about 7 times on each of the following energy points while repeating the Reminder Phrase at each point. The reminder phrase in my intervention –“ my anxiety about the operationâ€.
(Craig, 2011). The combination of tapping the energy meridians and voicing positive affirmation works to clear the emotional block from your bodys bio-energy system, thus restoring the mind and bodys balance |
| Comparator Agent |
Routine treatment with Emotional freedom Techniques Tapping |
Duration of EFT: 2 rounds of basic recipe at one session which takes about 10 minutes. 2 sessions are done on each subject on previous day and on the day of surgery. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.Women undergoing obstetrics and gynecological surgeries under spinal and general anesthesia.
2.Women with moderate to severe pre-interventional anxiety.
|
|
| ExclusionCriteria |
| Details |
1.Women with mild anxiety
2.Women practicing alternate relaxation therapies
3.Women on regular anxiolytic drugs.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce Anxiety |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better Surgical outcome |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Accepted for Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Emotional Freedom Techniques tapping is a used to reduce the anxieties of women before surgery of the sensitive genito urinary tract. Anxiety will be checked with Hamilton’s anxiety rating scale and the severity of the symptoms will be assessed .Immediate intervention will be given for reduction of anxiety and improvement of surgical nursing outcome. |