The Effect of the Emotional Freedom Technique Applied to Postmenopausal Women Before Probe Curettage on Pain, Anxiety and Vital Signs. (EFT-ANXIETY)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kahramanmaraş, Turkey (Türkiye), 4600
- Kahramanmaraş Sütçü İmam Üniversitesi
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Kahramanmaraş
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Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye), 4600
- kahramanmaraş NFK Obstetrics and Pediatrics Hospital Additional Service Building
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Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye), 4600
- Kahramanmaraş Sütçü İmam Üniversitesi
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Those who are in menopause
- Do not have conditions such as infection, wound or scar in the tapping areas,
- Having no problem communicating in Turkish,
- Those who have not used any analgesic medication in the last 24 hours,
- Those who have not had probe curettage before,
- Volunteer to participate in the study,
- Not using any medication that directly affects vital signs,
- Does not have a disease that would cause problems in feeling pain,
- Not using antidepressants, anxiolytics and sedative agents.
Exclusion Criteria:
• Those who are not in menopause
- Women who have had probe curettage before
- Their general condition deteriorates during the procedure or a different intervention is made with anesthesia,
- Any complications developed during the procedure,
- Those who experienced syncope during the procedure and the procedure was continued with general/local anesthesia,
- Having a psychiatric problem,
- Analgesic medication used during the procedure,
- Having cognitive, affective, perceptual problems.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: EFT İNVERTİON GROUP
During the initial consultation, the Personal Information Form, SUE Scale, State Anxiety Scale (SAS), Visual Analog Scale (VAS), vital signs (blood pressure, heart rate, and peripheral oxygen saturation/SpO2) Monitoring Form will be administered.
EFT, which lasts approximately 30-40 minutes, will be administered to women by the researcher.
Second measurement: Immediately after EFT, the SUE Scale, State Anxiety Scale (SAS), Visual Analog Scale (VAS), and vital signs (blood pressure, heart rate, and peripheral oxygen saturation/SpO2) will be administered again.
Following the second measurement, the probe curettage will be performed.
Third measurement: During the procedure, the VAS and vital signs (blood pressure, heart rate, and peripheral oxygen saturation/SpO2) Monitoring Form will be administered.
Fourth measurement: After the probe curettage, women will be given 2 minutes to rest.
The Visual Analog Scale (VAS) and vital signs (blood pressure, heart rate, and peripheral oxygen satur
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In this study, the effect of emotional freedom technique on pain, anxiety, and vital signs prior to the probe curettage procedure will be examined.
The EFT session will be administered by an EFT specialist approximately 40 minutes prior to the probe curettage procedure by tapping on the tapping points.
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No Intervention: control group
During the initial consultation, the Personal Information Form, SUE Scale, State Anxiety Scale (SAS), Visual Analog Scale (VAS), vital signs (blood pressure, heart rate, and peripheral oxygen saturation/SpO2) Monitoring Form will be administered.
Second measurement: The SUE Scale, State Anxiety Scale (SAS), Visual Analog Scale (VAS), and vital signs (blood pressure, heart rate, and peripheral oxygen saturation/SpO2) will be administered again simultaneously with the EFT group.
Following the second measurement, a probe curettage will be performed.
Third measurement: During the procedure, the VAS and vital signs (blood pressure, heart rate, and peripheral oxygen saturation/SpO2) Monitoring Form will be applied.
Fourth measurement: After the probe curettage, women will be given 2 minutes to rest.
The Visual Analog Scale (VAS) and vital signs (blood pressure, heart rate, and peripheral oxygen saturation/SpO2) Monitoring Form will be applied.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analogue Scale (VAS)
Time Frame: Baseline (pre-procedure) and during the probe curettage procedure.
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Pain intensity will be assessed using the Visual Analogue Scale (VAS), a numeric rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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Baseline (pre-procedure) and during the probe curettage procedure.
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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State-Trait Anxiety Inventory - State Version (STAI-I)
Time Frame: Baseline (pre-procedure) and immediately post-procedure.
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Anxiety levels will be assessed using the State-Trait Anxiety Inventory - State Version (STAI-I), which measures situational anxiety at a specific point in time.
The scale consists of 20 items, with total scores ranging from 20 to 80. Higher scores indicate greater levels of anxiety.
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Baseline (pre-procedure) and immediately post-procedure.
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Systolic and Diastolic Blood Pressure
Time Frame: Baseline (pre-procedure), during the probe curettage procedure, and immediately post-procedure (within 2 minutes after completion).
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Systolic and diastolic blood pressure will be measured to evaluate physiological responses associated with the probe curettage procedure and the effect of the Emotional Freedom Technique (EFT).
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Baseline (pre-procedure), during the probe curettage procedure, and immediately post-procedure (within 2 minutes after completion).
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Heart Rate
Time Frame: Baseline (pre-procedure), during the probe curettage procedure, and immediately post-procedure (within 2 minutes after completion).
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Heart rate will be measured to assess autonomic physiological responses related to anxiety, pain, and procedural stress during the probe curettage procedure.
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Baseline (pre-procedure), during the probe curettage procedure, and immediately post-procedure (within 2 minutes after completion).
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Peripheral Oxygen Saturation (SpO₂)
Time Frame: Baseline (pre-procedure), during the probe curettage procedure, and immediately post-procedure (within 2 minutes after completion).
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Peripheral oxygen saturation will be measured to monitor respiratory and physiological stability during and after the probe curettage procedure.
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Baseline (pre-procedure), during the probe curettage procedure, and immediately post-procedure (within 2 minutes after completion).
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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State-Uncertainty Emotion (SUE) Scale
Time Frame: Baseline (pre-procedure) and immediately post-procedure (within 2 minutes after completion).
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Emotional distress related to uncertainty will be assessed using the State-Uncertainty Emotion (SUE) Scale.
The scale is scored on a numeric scale from 0 to 10, where higher scores indicate greater emotional distress and uncertainty.
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Baseline (pre-procedure) and immediately post-procedure (within 2 minutes after completion).
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Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- KSU-MED-TRIAL-01
- 2024/109 (Other Identifier: Ethics Committee Protocol Number)
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
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