NCT07348068

Brief Summary

The aim of the study is to examine the effect of the emotional freedom technique applied to postmenopausal women before the probe curettage procedure on pain, anxiety and vital signs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 21, 2025

Last Update Submit

January 9, 2026

Conditions

Keywords

Anxiety, Pain, and Vital Signs

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    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.

    Baseline (pre-procedure) and during the probe curettage procedure.

Secondary Outcomes (4)

  • State-Trait Anxiety Inventory - State Version (STAI-I)

    Baseline (pre-procedure) and immediately post-procedure.

  • Systolic and Diastolic Blood Pressure

    Baseline (pre-procedure), during the probe curettage procedure, and immediately post-procedure (within 2 minutes after completion).

  • Heart Rate

    Baseline (pre-procedure), during the probe curettage procedure, and immediately post-procedure (within 2 minutes after completion).

  • Peripheral Oxygen Saturation (SpO₂)

    Baseline (pre-procedure), during the probe curettage procedure, and immediately post-procedure (within 2 minutes after completion).

Other Outcomes (1)

  • State-Uncertainty Emotion (SUE) Scale

    Baseline (pre-procedure) and immediately post-procedure (within 2 minutes after completion).

Study Arms (2)

EFT İNVERTİON GROUP

EXPERIMENTAL

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

Behavioral: emotional freedom technique

control group

NO INTERVENTION

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.

Interventions

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.

EFT İNVERTİON GROUP

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

kahramanmaraş NFK Obstetrics and Pediatrics Hospital Additional Service Building

Kahramanmaraş, Kahramanmaraş, 4600, Turkey (Türkiye)

Location

Kahramanmaraş Sütçü Imam Üniversitesi

Kahramanmaraş, Kahramanmaraş, 4600, Turkey (Türkiye)

Location

Kahramanmaraş Sütçü Imam Üniversitesi

Kahramanmaraş, 4600, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
"Participants were blinded to the specific details of the procedure being applied, including whether or not the emotional freedom technique (EFT) was used during the probe curettage procedure."
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: "This study uses a behavioral intervention model in which Emotional Freedom Techniques (EFT) are applied to postmenopausal women prior to a probe curettage procedure to examine its effects on pain, anxiety, and quality of life. EFT is a technique that involves gently tapping on specific acupuncture points while focusing on emotional distress. The intervention aims to reduce anxiety related to pain and improve overall quality of life. The study will evaluate the effectiveness of EFT applied prior to the probe curettage procedure on pain, anxiety, and quality of life during the procedure in postmenopausal women."
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
graduate student

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 16, 2026

Study Start

February 1, 2025

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) will not be shared due to privacy concerns and to ensure confidentiality of personal information. Additionally, the data is collected for a specific study and will not be made available for secondary analyses.

Locations