Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000291583
Ethics application status
Approved
Date submitted
25/11/2023
Date registered
20/03/2024
Date last updated
20/03/2024
Date data sharing statement initially provided
20/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Emotional Freedom Techniques: a novel psychological approach t0 depression and Quality of life in Post -Stroke Patients.
Scientific title
'A randomized controlled trial investigating the feasibility and efficacy of Emotional Freedom Techniques (EFT) in decreasing depression amongst Pakistani stroke survivors.'
Secondary ID [1] 311030 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 332146 0
post-stroke 332707 0
Condition category
Condition code
Stroke 328869 328869 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention name is Emotional Freedom Technique (EFT)
The Emotional Freedom Technique (EFT) is a Psychological modality, also known as tapping, involves participants tapping on specific points on their body with their fingertips. These points are based on traditional Chinese medicine meridian points. Here are the basic tapping locations:

Karate Chop Point (KC): This is on the fleshy part on the side of your hand, between the base of the pinky finger and the wrist. You tap this point with the opposite hand's fingertips.

Top of the Head (TH): This is the crown of your head. Use all fingers of one or both hands to tap gently.

Eyebrow (EB): Located at the beginning of your eyebrow, near the bridge of your nose. Tap with two fingers.

Side of the Eye (SE): On the bone at the outer edge of your eye. Again, use two fingers to tap.

Under the Eye (UE): On the bone under your eye, in line with your pupil. Tap with two fingers.

Under the Nose (UN): Above your upper lip, just under your nose. Tap with one or two fingers.

Chin Point (CP): Midway between the point of your chin and the bottom of your lower lip. Use one or two fingers to tap.

Collarbone Point (CB): Just below the hard ridge of your collarbone. Tap with all your fingers or use a fist.

Under the Arm (UA): On the side of your body, about four inches below the armpit. Use one or two fingers.

While tapping on these points, participants usually repeat statements related to their emotional issue or distress. The process is designed to address and release negative emotions, reduce stress, and promote emotional well-being.

The process of Emotional freedom technique
Identify the Issue: Individuals using EFT first identify a specific issue, whether it be a negative emotion, a traumatic memory, or a limiting belief.
The Setup: During this phase, the person acknowledges the problem and accepts themselves despite it, using a setup statement while tapping on the karate chop point on the hand.
Tapping Sequence: The individual then taps on specific meridian points while focusing on the identified issue. This sequence is repeated until the emotional intensity decreases.
Reassessment: After completing the tapping sequence, individuals reassess their emotional state. The goal is to achieve a sense of calm and acceptance regarding the issue.

Applications of Emotional Freedom Technique:
EFT is used to address a wide range of emotional and psychological issues, including anxiety ,depression, phobias, traumatic memories, stress, sleeping disorder and limiting beliefs.

the duration of the intervention will be one hour consultation and the mode of administration will be in group therapy only. and monitor the adherence to the intervention through clinical attendance checklist and audit of medical records .

Primary investigator is Psychologist will deliver the intervention, she has 25 years of experience. it will be based on face to face and group therapy. the intervention will be deliver twice a week and duration will be 8 weeks then break and after 4 weeks re-evaluate technique effectiveness of intervention with the double blind technique. Total duration will be 12 weeks (3 months).
location will be Islamabad and Rawalpindi hospitals and neuro-rehabilitation hospital and home based patients.

participants will maintain their current traditional rehabilitation therapies, at discretion of physician and rehab specialist
Intervention code [1] 327479 0
Rehabilitation
Comparator / control treatment

Control Group:
Receives only traditional rehabilitation therapies. Participants will maintain their current traditional rehabilitation therapies, at discretion of physician and Rehab specialists.
Does not receive the experimental treatment (EFT).
Control group
Active

Outcomes
Primary outcome [1] 336667 0
The primary outcome of this study is 'Change in subjective depression rating'.
Timepoint [1] 336667 0
time point: baseline 12 weeks after randomization
Secondary outcome [1] 429272 0
To assess the impact of Emotional Freedom Technique (EFT) on subjective distress levels (SUDs) in stroke survivors in Pakistan, using validated psychological assessments.
Timepoint [1] 429272 0
weekly from baseline to 12 weeks after intervention
Secondary outcome [2] 429273 0
To examine the long-term impact or sustainability of Emotional Freedom Technique (EFT) on r depression symptoms among stroke survivors in Pakistan.
Timepoint [2] 429273 0
weekly from baseline to 12 weeks after intervention
Secondary outcome [3] 431145 0
quality of life
The secondary objective of this study is to assess any changes in the quality of life (QOL) of stroke survivors following the application of Emotional Freedom Technique (EFT).
Timepoint [3] 431145 0
weekly from baseline to 12 weeks after intervention
Secondary outcome [4] 431146 0
long term quality of life
Timepoint [4] 431146 0
Weekly from baseline t0 12 weeks after intervention

Eligibility
Key inclusion criteria
inclusion criteria will be the patient diagnosed with ischemic stroke with good reception and are able to talk (Mini Mental State Examination (MMSE) will use for screening and age from 30 to 60 years, and experience low mood, lack of pleasure, depression(Beck depression inventory will use for evaluation)
Mini Mental State Examination (MMSE) score will be greater than 17.
High score on Beck Depression inventory.
Family member or caregiver willing and able to participate in patient's treatment
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusive criteria: with other neurological condition (dementia, autoimmune disease etc) and more than 70 years and included unstable co-morbid condition, severe cognitive, and/or communication difficulties that would interfere with participation. MMSE score less than 17. severe aphasia. a history of epileptic seizures or a first degree relative with epilepsy. Presence of illnesses other than stroke (e.g., untreated thyroid or adrenal disease, pancreatic cancer, and lymphoma) current involvement in other psychological therapy (Taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerized sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
using Morgan formula for sample size
total 100 participants (50 participants in each group)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2024
Actual
Sample size
Target
100
Accrual to date
90
Final
Recruitment outside Australia
Country [1] 25990 0
Pakistan
State/province [1] 25990 0
Islamabad

Funding & Sponsors
Funding source category [1] 315691 0
Self funded/Unfunded
Name [1] 315691 0
Muhammad Alauddin
Country [1] 315691 0
Pakistan
Primary sponsor type
Individual
Name
Muhammad Alauddin
Address
Health Services Academy, Opposite National Institute of Health, Park road, chak Shahzad, Islamabad, post code 44000
Country
Pakistan
Secondary sponsor category [1] 317796 0
None
Name [1] 317796 0
Address [1] 317796 0
Country [1] 317796 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314215 0
Institutional Ethical Review Committee (IERC), Health Services Academy
Ethics committee address [1] 314215 0
Ethics committee country [1] 314215 0
Pakistan
Date submitted for ethics approval [1] 314215 0
03/10/2023
Approval date [1] 314215 0
10/11/2023
Ethics approval number [1] 314215 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130810 0
Mrs Shazia Shahzadi
Address 130810 0
Health Services Academy, Opposite National Institute of Health, Park road, chak Shahzad, Islamabad, post code 44000
Country 130810 0
Pakistan
Phone 130810 0
+923312722929
Fax 130810 0
Email 130810 0
[email protected]
Contact person for public queries
Name 130811 0
Shazia Shahzadi
Address 130811 0
Health Services Academy, Opposite National Institute of Health, Park road, chak Shahzad, Islamabad, post code 44000
Country 130811 0
Pakistan
Phone 130811 0
+923312722929
Fax 130811 0
Email 130811 0
[email protected]
Contact person for scientific queries
Name 130812 0
Shazia Shahzadi
Address 130812 0
Health Services Academy, Opposite National Institute of Health, Park road, chak Shahzad, Islamabad, post code 44000
Country 130812 0
Pakistan
Phone 130812 0
+923312722929
Fax 130812 0
Email 130812 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.