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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06296927
Other study ID # SumeyyeKose-E.138186
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date March 1, 2025

Study information

Verified date March 2024
Source Saglik Bilimleri Universitesi
Contact Sumeyye Kose
Phone 2163961630
Email sumeyyekose28@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was planned to determine the effect of Emotional Freedom Technique on perceived pain level, situational anxiety, salivary cortisol and satisfaction level during mammography screening.


Description:

The randomized controlled and experimental study will be conducted with 76 women who apply to the Cancer Early Diagnosis, Screening and Training Center for mammography screening. Women in the experimental group (n=38) will undergo Emotional Freedom Technique before mammography screening, and women in the control group (n=38) will undergo routine mammography screening. Information Form Containing Sociodemographic Information, Visual Analog and Situational Anxiety Inventory will be used to collect data.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 76
Est. completion date March 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 50 Years
Eligibility Inclusion Criteria: - Having a first mammography screening - Knowing how to read and write, - Having entered menopause (at least 1 year has passed since the last menstruation) Exclusion Criteria: - Having any cognitive or hearing-related problems, - Having used analgesic medication before the procedure, - Not having chronic diseases (insulin resistance, hypertension, obesity) (as saliva may affect cortisol level), - Having a psychiatrically diagnosed disease (Schizophrenia, bipolar disorder) - Having epilepsy (since it is contraindicated for EFT applications), - Presence of oral diseases, inflammation or lesions (as saliva may affect cortisol level), - Having eaten, drank, chewed gum or brushed teeth 30 minutes before.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Emotional Freedom Technique
The researcher will apply the Emotional Freedom Technique to women in the intervention group who apply for mammography screening for 30-40 minutes before the screening.

Locations

Country Name City State
Turkey Pendik District Health Directorate Maternal Child Health and Family Planning Center Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety Data will be collected using the State Anxiety Inventory. The answer options collected in four classes on the State Anxiety Inventory scale are: (1) Not at all, (2) A little, (3) A lot and (4) Completely; The options on the trait anxiety scale are (1) Rarel, (2) Sometimes, (3) A lot of the time, and (4) Almost always. The higher the score obtained from the scales, the higher the person's anxiety is. The total score obtained from the scale varies between 20-80, and 20-39 indicates a mild anxiety level, 40-59 indicates a medium anxiety level, 60-79 indicates a high anxiety level, and 80 points indicates a panic anxiety level. 20 minute
Primary Pain Level Data will be collected using the Visual Analogue Scale. Pain can be given a score between 0 and 10 on the scale.The higher the scale score, the greater the pain. 10 minute
Secondary Satisfaction Level Data will be collected using the Visual Analog Scale. Satisfaction can be given a score between 0 and 10 on the scale. The higher the scale score, the higher the satisfaction level. 10 minutes
Secondary Cortisol Level Data will be collected using saliva ELISA kits. Analyzes will be done in the biochemistry laboratory. The higher the result, the higher the cortisol level. 10 minutes
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