Emotional DistressNCT05359458
Emotional Freedom Liberation Technique, Surgical Fear and Anxiety
A study testing Emotional Freedom Liberation Technique in people with Emotional Distress, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Aim: In this study, the effect of Emotional Freedom Technique applied to patients before Laparoscopic Cholecystectomy on surgical fear and anxiety was investigated. Design: This is a randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emotional Distress
- What is being tested?
- Emotional Freedom Liberation Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical treatment for Laparoscopic Cholecystectomy
- 18 years of age or older
- Mentally healthy
Who cannot join
- Agree to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University
Erzurum, ABD Veya Kanada'da Lütfen Seçin ..., 25070
About this study
Official title: The Effect of Emotional Freedom Liberation Technique on Surgical Fear and Anxiety Applied to Patients Before Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Aim: In this study, the effect of Emotional Freedom Technique applied to patients before Laparoscopic Cholecystectomy on surgical fear and anxiety was investigated.
Design: This is a randomized controlled study. Method: A total of 112 patients who were going to have Laparoscopic Cholecystectomy were randomly divided into two groups each including 56 participants. The intervention group was provided with Emotional Freedom Technique. The control group received routine face-to-face education. Surgical fear and anxiety were examined.
- Conditions
- Emotional Distress
- Being tested
- Emotional Freedom Liberation Technique
- Keywords
- surgery, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Freedom Liberation TechniqueBehavioural
The investigators will apply Emotional Freedom Liberation Technique
| Study group | Role | What they receive |
|---|---|---|
| Emotional Freedom Liberation Technique Applied to Laparoscopic Cholecystectomy Patients | Experimental | The intervention group is the group in which the investigators applied Emotional Freedom Liberation Technique Intervention: Behavioral: Emotional Freedom Liberation Technique Receives: Behavioral: Emotional Freedom Liberation Technique |
| Standard Clinical Care Applied to Laparoscopic Cholecystectomy Patients | No intervention | The control group is the group that receives standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Fear Scale
Surgical Fear Scale will be filled in the preoperative period. ll items are scored on an eleven point numeric rating scale (NRS) ranging from 0 (not at all afraid) to 10 (very afraid). This results in a score of 0-40 for each subscale and a total score of 0 to 80.
Measured: through study completion, an average of 5 month
Secondary outcomes (1)
Anxiety Scale
Anxiety scale will be filled in the preoperative period. The scale consists of 10 statements that include the fears that patients may experience about the surgery. The maximum score that can be obtained from the scale is 50. High scores in scale scoring reflect concerns about pain, death during surgery, and postoperative complications and limitations.
Measured: through study completion, an average of 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Aug 2021
- Primary completion1 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Yayla, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359458
- Sponsor's protocol ID
- AEP17
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Emotional Freedom Liberation Technique on Surgical Fear and Anxiety Applied to Patients Before Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05359458
- Acronym / sponsor ID
- AEP17
- Conditions
- Emotional Distress
- Keywords
- surgery, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: In this study, the effect of Emotional Freedom Technique applied to patients before Laparoscopic Cholecystectomy on surgical fear and anxiety was investigated.
Design: This is a randomized controlled study. Method: A total of 112 patients who were going to have Laparoscopic Cholecystectomy were randomly divided into two groups each including 56 participants. The intervention group was provided with Emotional Freedom Technique. The control group received routine face-to-face education. Surgical fear and anxiety were examined.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotional Freedom Liberation Technique Applied to Laparoscopic Cholecystectomy Patients | Experimental | Behavioral: Emotional Freedom Liberation TechniqueThe intervention group is the group in which the investigators applied Emotional Freedom Liberation Technique Intervention: Behavioral: Emotional Freedom Liberation Technique |
| Standard Clinical Care Applied to Laparoscopic Cholecystectomy Patients | No intervention | –The control group is the group that receives standard clinical care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical treatment for Laparoscopic Cholecystectomy
- 18 years of age or older
- Mentally healthy
Key exclusion criteria (1 listed)
- Agree to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Freedom Liberation TechniqueThe investigators will apply Emotional Freedom Liberation Technique | Behavioural | Emotional Freedom Liberation Technique Applied to Laparoscopic Cholecystectomy Patients |
Primary outcome
Surgical Fear Scale
Time frame: through study completion, an average of 5 month
Surgical Fear Scale will be filled in the preoperative period. ll items are scored on an eleven point numeric rating scale (NRS) ranging from 0 (not at all afraid) to 10 (very afraid). This results in a score of 0-40 for each subscale and a total score of 0 to 80.
1 secondary outcome
Anxiety Scale
Time frame: through study completion, an average of 5 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Freedom Liberation Technique in people with Emotional Distress, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Fear Scale (time frame: through study completion, an average of 5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.