- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06780371
Kinesiophobia and Pressure Sore Risk After Bariatric Surgery.
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:
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bitlis, Turkey (Türkiye), 13100
- Bitlis Eren University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being 18 years of age or older
- Having had obesity surgery
- Not having any visual or auditory problems
- Not having any psychiatric problems.
Exclusion Criteria:
- Not accepting to participate in the study or wanting to leave
- Being under 18 years of age.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: 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.
|
Emotional Freedom Technique application; It is an application that works on cognitive and energetic levels. Emotional Freedom Technique Application Instructions
|
|
No Intervention: No Intervention: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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"
|
20 minutes
|
|
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 |
20 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Şerafettin OKUTAN, PhD., Bitlis Eren University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Okutan3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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