- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07454044
Nurse-Led Emotional Freedom Technique for Preoperative Anxiety and Fear in Thyroid Surgery (EFT)
The Effect of Emotional Freedom Techniques on Preoperative Anxiety and Fear in Patients Undergoing Thyroid Surgery
Emotional Freedom Technique (EFT) is a non-invasive, low-cost complementary intervention that has been used in various clinical settings to reduce anxiety and psychological distress. Although previous studies have suggested the potential benefits of EFT in general anxiety and postoperative psychological outcomes, evidence regarding its effectiveness in patients undergoing thyroid surgery is limited. Thyroid surgery is associated with unique sources of preoperative anxiety and fear due to potential complications related to voice, swallowing, and hormonal balance.
This randomized controlled study aims to evaluate the effect of Emotional Freedom Technique on preoperative anxiety and fear in patients undergoing thyroid surgery. Eligible patients will be randomly assigned to an intervention group receiving EFT in addition to standard preoperative nursing care or to a control group receiving standard preoperative nursing care alone. EFT will be administered by trained nurses following a standardized protocol during the preoperative period. Anxiety and fear levels will be assessed using validated measurement tools before and after the intervention. The findings of this study are expected to contribute to evidence-based nursing practices and to support the integration of complementary interventions into perioperative nursing care.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed as a randomized controlled trial with a pretest-posttest control group design. The study will be conducted in the surgical clinic of Yeditepe University Koşuyolu Hospital among patients scheduled for thyroid surgery. Participants will be randomly assigned to either an intervention group or a control group.
The intervention group will receive Emotional Freedom Technique in addition to routine preoperative nursing care, while the control group will receive routine preoperative nursing care only. Emotional Freedom Technique will be administered by trained nurses in a quiet and comfortable environment during the preoperative period. Preoperative anxiety and fear levels will be assessed before and after the intervention using validated measurement tools. The study aims to evaluate the effect of Emotional Freedom Technique on preoperative anxiety and fear within the scope of perioperative nursing care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kamile Yaren Behlevan
- Phone Number: +905372468285
- Email: yaren.behlevan@gmail.com
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Yeditepe University Kosuyolu Hospital
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Contact:
- Kamile Yaren Behlevan
- Phone Number: +905372468285
- Email: yaren.behlevan@gmail.com
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Principal Investigator:
- Selda Rızalar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients scheduled for thyroid surgery
- Aged 18 years and older
- Able to speak and understand Turkish
- Literate (able to read and write)
- No visual, hearing, or mental impairment
- Able to communicate effectively
- Preoperative anxiety and fear level of 3 or higher according to the Subjective Units of Distress (SUD) scale
Exclusion Criteria:
- Presence of a neurological disorder
- Diagnosed psychiatric disorder and current use of medication for this condition
- Previous training related to coping with anxiety or fear
- Previous participation in an energy therapy course
- Presence of infection, wound, or scar at the tapping (touch) sites
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants in this group will receive Emotional Freedom Technique in addition to routine preoperative nursing care.
|
Emotional Freedom Technique will be administered by trained nurses during the preoperative period according to a standardized protocol.
|
|
No Intervention: Control Group
Participants in this group will receive routine preoperative nursing care only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Surgical Anxiety Scale for Adult Patients Total Score (Range: 0-68)
Time Frame: From baseline (pre-intervention) to immediately after the intervention (approximately 30 minutes later, preoperatively).
|
Total score measured using the Surgical Anxiety Scale for Adult Patients.
Scores range from 0 to 68, with higher scores indicating greater anxiety.
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From baseline (pre-intervention) to immediately after the intervention (approximately 30 minutes later, preoperatively).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Surgical Fear Questionnaire (SFQ) Total Score (Range: 0-80)
Time Frame: From baseline (pre-intervention, preoperative period) to immediately after the intervention (approximately 30 minutes later, preoperatively).
|
Total score measured using the Surgical Fear Questionnaire (SFQ).
The scale consists of 8 items rated on an 11-point Likert scale (0-10), with total scores ranging from 0 to 80. Higher scores indicate greater surgical fear.
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From baseline (pre-intervention, preoperative period) to immediately after the intervention (approximately 30 minutes later, preoperatively).
|
|
Change in Subjective Units of Distress (SUD) Score (Range: 0-10)
Time Frame: Immediately before and immediately after the EFT session (approximately 25-30 minutes).
|
Measured using the Subjective Units of Distress Scale (SUDS).
Scores range from 0 to 10, with higher scores indicating greater emotional distress.
|
Immediately before and immediately after the EFT session (approximately 25-30 minutes).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Selda Rızalar, Saglik Bilimleri Universitesi
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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