NCT05358392

Brief Summary

This study will be conducted to investigate the effect of Emotional Freedom Technique (EFT) Application on infertility stress in women undergoing infertility treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

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

April 21, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

April 21, 2022

Last Update Submit

November 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • INFERTILITY STRESS SCALE score

    This scale, which will be applied to evaluate the stress experienced by infertile women.The scale has three sub-dimensions related to "personal", "marriage" and "social" fields and consists of 14 items in total.

    change from baseline ınfertility stress scale score ( approximately 15 days later ınfertility treatment)

Secondary Outcomes (2)

  • Subjective Level of Discomfort

    1,2,3,4,5. times EFT ıntervention (First 15 days of ınfertility treatment)

  • pregnancy status (positive or negativity according to BHCG value)

    30 days later of ınfertility treatment

Study Arms (2)

emotional freedom technique

EXPERIMENTAL

5 sessions of EFT\* will be applied to this group on the first day of the treatment, 1st Control, 2nd Control, before the OPU procedure and before the embryo transfer. Subjective discomfort level will be measured with SUD\*\* before and after each application.

Other: emotional freedom technique (EFT)

control

NO INTERVENTION

No application will be made to this group. Infertility stress scale will be filled in the case and control group at the beginning of the treatment and after the embryo transfer.

Interventions

EFT is an energy psychotherapy derivative application, consisting of cognitive and somatic components, used to heal personal negative emotions and related emotional and physical disorders. Stress hormones are secreted in response to the stress response in the person, and then the amygdala and other cerebral parts that respond to stress are activated. There are basic steps to be followed in EFT application; By giving a message to the emotional body (subconscious) with suggestion sentences, clicks are made on the twelve energy meridian endpoints (acupressure points).

emotional freedom technique

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women who have applied to the IVF clinic for primary infertility treatment,
  • in the initial stage of IVF/ICSI treatment,
  • literate in Turkish,
  • have no chronic disease,
  • have no diagnosed psychiatric disease,
  • between the ages of 18-40,
  • agree to participate in the study.

You may not qualify if:

  • Women want to leave the study (for the intervention group) before the implementation phases are completed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gonca Karataş Baran

Ankara, Eyalet/Yerleşke, 06290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • GONCA K KARATAS BARAN, PHD

    Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
: Women who applied to Etlik Zübeyde Hanım Gynecology Training and Research Hospital IVF/ICSI unit for IVF/ICSI treatment. who meet the criteria for inclusion in the study will be informed about the study, and the women who accept the study will be assigned to the groups determined by randomization.After participating in the study, the participants will know which group they are in.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Since there is no reference study on this subject, the effect width will be calculated for the main research question by making a preliminary application (9 cases, 9 controls) and the sample will be calculated with 90 power and 0.05 margin of error in the effect width obtained. Block randomization (3 blocks as male infertility, female infertility and unexplained infertility) for the pre-application intervention and control groups was performed through the Randomization Sofcare Allocation program. In the main application, this program will be made according to the number of samples and the intervention and control groups will be assigned. Pre-application data will be included in the research analysis. The Patient Follow-up Form consists of 3 parts. In the first part, there are data on socio-demographic and obstetric characteristics. The second part includes the infertility stress scale (pre-test) and the third part includes the infertility stress scale (post-test).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Nurse

Study Record Dates

First Submitted

April 21, 2022

First Posted

May 3, 2022

Study Start

May 1, 2022

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

November 22, 2024

Record last verified: 2024-11

Locations