KinesiophobiaNCT06780371
Kinesiophobia and Pressure Sore Risk After Bariatric Surgery.
A study testing Emotional Freedom Technique in people with Kinesiophobia and Pressure Sore, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of emotional freedom technique on kinesiophobia and the risk of developing pressure sores in patients undergoing obesity surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kinesiophobia, Pressure Sore, Emotional Freedom Technique
- What is being tested?
- Emotional Freedom Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2025to 7 Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older
- Having had obesity surgery
- Not having any visual or auditory problems
- Not having any psychiatric problems.
Who cannot join
- Not accepting to participate in the study or wanting to leave
- Being under 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University
The aim of this study was to investigate the effect of emotional freedom technique on kinesiophobia and the risk of developing pressure sores in patients undergoing obesity surgery.
The hypotheses of the study are as follows:
Read more
H1-0: Emotional liberation technique has no effect on kinesiophobia in patients undergoing bariatric surgery.
H1-1: Emotional liberation technique has a positive effect on kinesiophobia in patients undergoing bariatric surgery.
H2-0: Emotional liberation technique has no effect on the risk of developing pressure ulcers in patients undergoing bariatric surgery.
H2-1: Emotional liberation technique has a positive effect on the risk of developing pressure ulcers in patients undergoing bariatric surgery.
Read the detailed description
Intervention Group: After the pre-test application (Personal Introduction Form, Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) EFT was applied to the patients when they were stable before the bariatric surgery and they were taught to do it on their own. After the bariatric surgery, the patients were asked to do 1 session of EFT and were accompanied. After the application, the patients were applied post-tests (Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale). EFT training was given by a researcher who has a certificate in the field.
Control Group Patients were administered pre-tests (Personal Introduction Form, Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) at a stable time before bariatric surgery. Post-tests (Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) were administered to patients after bariatric surgery at a stable time. After the post-tests, EFT was administered to patients in the control group.
- Conditions
- Kinesiophobia, Pressure Sore, Emotional Freedom Technique, Complementary Therapies, Bariatric Surgery
- Being tested
- Emotional Freedom Technique
- Keywords
- pressure sore, Kinesiophobia, emotional freedom technique
- Medical subject headings
- Kinesiophobia, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Freedom TechniqueOther
Emotional Freedom Technique application; It is an application that works on cognitive and energetic levels.
Emotional Freedom Technique Application Instructions
- Determination of Subjective Units of Disturbance (SUD)
- Preparation or setup
- Application of appropriate acupuncture points in order
- 9-Gamut: An application that allows the two hemispheres of the brain to be stimulated simultaneously
- Application of appropriate acupuncture points in order again
- Control of the differentiation in the level of discomfort with SUDS again
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention Group | Experimental | After the pre-test application (Personal Introduction Form, Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) EFT was applied to the patients when they were stable before the bariatric surgery and they were taught to do it on their own. After the bariatric surgery, the patients were asked to do 1 session of EFT and were accompanied. After the application, the patients were applied post-tests (Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale). EFT training was given by a researcher who has a certificate in the field. Receives: Other: Emotional Freedom Technique |
| No Intervention: Control Group | No intervention | Pre-tests were administered to patients (Personal Introduction Form, Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) at a stable time before bariatric surgery. Post-tests (Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) were administered to patients (Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) at a stable time after bariatric surgery. After the post-tests, EFT was administered to patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
kinesiophobia level
It is a scale that measures movement restriction. As a result of the survey, the person receives a total score between 17-68 according to the answers they give. A high score on the scale indicates that the person has a high level of kinesiophobia. Those with a score above 37 are grouped as "high level kinesiophobia", those with a score of 37 and below are grouped as "low level kinesiophobia"
Measured: 20 minutes
pressure ulcer risk
The Braden Scale was developed in 1987 by Nancy Bergstrom, Barbara J. Braden and their colleagues for the early diagnosis of patients at risk of pressure ulcers.
The lowest score that can be obtained from the scale is 6, and the highest score is 23. Patients who receive 12 points or less from the scale are considered high risk, 13-14 points are considered risky, 15-16 points are considered low risk, and 15-18 points are considered low risk in patients over the age of 75
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start15 Feb 2025
- Primary completion25 Sep 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KinesiophobiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- It will be conducted as a randomized controlled experimental study in a pre-test-post-test control group experimental model.
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serafettin Okutan, Bitlis Eren University
- Investigators
- Şerafettin OKUTAN, PhD., Principal investigator, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780371
- Sponsor's protocol ID
- Okutan3
- Status last verified
- Nov 2025
- First submitted
- 13 Jan 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University
- ClinicalTrials.gov ID
- NCT06780371
- Acronym / sponsor ID
- Okutan3
- Conditions
- Kinesiophobia, Pressure Sore, Emotional Freedom Technique, Complementary Therapies, Bariatric Surgery
- Keywords
- pressure sore, Kinesiophobia, emotional freedom technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 17 Jan 2025 (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.
The aim of this study was to investigate the effect of emotional freedom technique on kinesiophobia and the risk of developing pressure sores in patients undergoing obesity surgery.
The hypotheses of the study are as follows:
H1-0: Emotional liberation technique has no effect on kinesiophobia in patients undergoing bariatric surgery.
H1-1: Emotional liberation technique has a positive effect on kinesiophobia in patients undergoing bariatric surgery.
H2-0: Emotional liberation technique has no effect on the risk of developing pressure ulcers in patients undergoing bariatric surgery.
H2-1: Emotional liberation technique has a positive effect on the risk of developing pressure ulcers in patients undergoing bariatric surgery.
Detailed description
Intervention Group: After the pre-test application (Personal Introduction Form, Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) EFT was applied to the patients when they were stable before the bariatric surgery and they were taught to do it on their own. After the bariatric surgery, the patients were asked to do 1 session of EFT and were accompanied. After the application, the patients were applied post-tests (Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale). EFT training was given by a researcher who has a certificate in the field.
Control Group Patients were administered pre-tests (Personal Introduction Form, Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) at a stable time before bariatric surgery. Post-tests (Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) were administered to patients after bariatric surgery at a stable time. After the post-tests, EFT was administered to patients in the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It will be conducted as a randomized controlled experimental study in a pre-test-post-test control group experimental model.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Group | Experimental | Other: Emotional Freedom TechniqueAfter the pre-test application (Personal Introduction Form, Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) EFT was applied to the patients when they were stable before the bariatric surgery and they were taught to do it on their own. After the bariatric surgery, the patients were asked to do 1 session of EFT and were accompanied. After the application, the patients were applied post-tests (Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale). EFT training was given by a researcher who has a certificate in the field. |
| No Intervention: Control Group | No intervention | –Pre-tests were administered to patients (Personal Introduction Form, Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) at a stable time before bariatric surgery. Post-tests (Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) were administered to patients (Tampa Kinesiophobia Scale and Braden Pressure Sore Risk Assessment Scale) at a stable time after bariatric surgery. After the post-tests, EFT was administered to patients in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 years of age or older
- Having had obesity surgery
- Not having any visual or auditory problems
- Not having any psychiatric problems.
Key exclusion criteria (2 listed)
- Not accepting to participate in the study or wanting to leave
- Being under 18 years of age.
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 TechniqueEmotional Freedom Technique application; It is an application that works on cognitive and energetic levels. Emotional Freedom Technique Application Instructions 1. Determination of Subjective Units of Disturbance (SUD) 2. Preparation or setup 3. Application of appropriate acupuncture points in order 4. 9-Gamut: An application that allows the two hemispheres of the brain to be stimulated simultaneously 5. Application of appropriate acupuncture points in order again 6. Control of the differentiation in the level of discomfort with SUDS again | Other | Experimental: Intervention Group |
Primary outcome
kinesiophobia level
Time frame: 20 minutes
It is a scale that measures movement restriction. As a result of the survey, the person receives a total score between 17-68 according to the answers they give. A high score on the scale indicates that the person has a high level of kinesiophobia. Those with a score above 37 are grouped as "high level kinesiophobia", those with a score of 37 and below are grouped as "low level kinesiophobia"
pressure ulcer risk
Time frame: 20 minutes
The Braden Scale was developed in 1987 by Nancy Bergstrom, Barbara J. Braden and their colleagues for the early diagnosis of patients at risk of pressure ulcers. The lowest score that can be obtained from the scale is 6, and the highest score is 23. Patients who receive 12 points or less from the scale are considered high risk, 13-14 points are considered risky, 15-16 points are considered low risk, and 15-18 points are considered low risk in patients over the age of 75
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 4 Dec 2025.
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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.
Şerafettin OKUTAN, PhD. principal investigator
Bitlis Eren University
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 Technique in people with Kinesiophobia and Pressure Sore, run by Bitlis Eren 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 4 inclusion and 2 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 4 Dec 2025. 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?
kinesiophobia level (time frame: 20 minutes). The study lists 2 primary outcomes in all. 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 4 Dec 2025.